| Literature DB >> 34178059 |
Ricardo de Ávila Oliveira1,2, Eliza Nakajima2, Vladimir Tonello de Vasconcelos2, Rachel Riera2, José Carlos Costa Baptista-Silva2.
Abstract
We conducted a systematic review to compare the effectiveness and safety of exercise versus no exercise for patients with asymptomatic aortic aneurysm. We followed the guidelines set out in the Cochrane systematic review handbook. We searched Medline, Embase, CENTRAL, LILACS, PeDRO, CINAHL, clinicaltrials.gov, ICTRP, and OpenGrey using the MeSH terms "aortic aneurysm" and "exercise". 1189 references were identified. Five clinical trials were included. No exercise-related deaths or aortic ruptures occurred in these trials. Exercise did not reduce the aneurysm expansion rate at 12 weeks to 12 months (mean difference [MD], -0.05; 95% confidence interval [CI], -0.13 to 0.03). Six weeks of preoperative exercise reduced severe renal and cardiac complications (risk ratio, 0.54; 95% CI, 0.31-0.93) and the length of intensive care unit stay (MD, -1.00; 95% CI, -1.26 to -0.74). Preoperative and postoperative forward walking reduced the length of hospital stay (MD, -0.69; 95% CI, -1.24 to -0.14). The evidence was graded as 'very low' level.Entities:
Keywords: abdominal aortic aneurysm; aortic aneurysm; exercise; postoperative complications
Year: 2020 PMID: 34178059 PMCID: PMC8202166 DOI: 10.1590/1677-5449.190086
Source DB: PubMed Journal: J Vasc Bras ISSN: 1677-5449
MEDLINE search strategy.
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| (“Aortic Aneurysm”[Mesh] OR (Aortic Aneurysm) OR (Aneurysms, Aortic) OR (Aortic Aneurysms) OR (Aneurysm, Aortic)) AND ((“Exercise”[Mesh]) OR (Exercise) OR (Exercises) OR (Exercise, Physical) OR (Exercises, Physical) OR (Physical Exercise) OR (Physical Exercises) OR (Exercise, Isometric) OR (Exercises, Isometric) OR (Isometric Exercises) OR (Isometric Exercise) OR (Exercise, Aerobic) OR (Aerobic Exercises) OR (Exercises, Aerobic) OR (Aerobic Exercise) OR “Physical Fitness”[Mesh] OR (Fitness, Physical) OR (Physical Fitness) OR “Exercise Therapy”[Mesh] OR (Therapy, Exercise) OR (Exercise Therapies) OR (Therapies, Exercise) OR “Physical Exertion”[Mesh] OR (Exertion, Physical) OR (Exertions, Physical) OR (Physical Exertions) OR (Physical Effort) OR (Effort, Physical) OR (Efforts, Physical) OR (Physical Efforts) OR “Sports”[Mesh] OR (Sport) OR (Athletics) OR (Athletic) OR “Exercise Movement Techniques”[Mesh] OR (Movement Techniques, Exercise) OR (Exercise Movement Technics) OR (Pilates-Based Exercises) OR (Exercises, Pilates-Based) OR (Pilates Based Exercises) OR (Pilates Training) OR (Training, Pilates) OR “Physical Endurance”[Mesh] OR (Endurance, Physical) OR (Endurances, Physical) OR (Physical Endurances)) |
GRADEpro-GDT judgment of the quality of evidence: GRADE question: Should exercise be indicated for patients with aortic aneurysms at surveillance?
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| Mortality follow up: range 7 weeks to 12 weeks | 0 per 100 | 0 per 100 (0 to 0) | not estimable | 263 (4 RCTs) | ⨁◯◯◯ VERY LOW a,b,c,d |
| Aortic rupture follow up: range 7 weeks to 12 weeks | 0 per 100 | 0 per 100 (0 to 0) | not estimable | 263 (4 RCTs) | ⨁◯◯◯ VERY LOW a,b,c,d |
| Aneurysm growth rate follow up: range 7 weeks to 12 weeks | The mean aneurysm growth rate was 0 | The mean aneurysm growth rate in the exercise group was 0.06 lower (0.23 lower to 0.11 higher) | - | (2 RCTs) | ⨁◯◯◯ VERY LOW b,c,d,e |
| Number of patients with at least one cardiovascular complication follow up: range 7 weeks to 12 weeks | 0 per 100 | 0 per 100 (0 to 0) | RR 100.00 (0.07 to 35.46) | 263 (4 RCTs) | ⨁◯◯◯ VERY LOW a,b,c,d |
| Number of patients who reached threshold for surgery follow up: range 7 weeks to 12 weeks | 0 per 100 | 0 per 100 (0 to 0) | not estimable | 263 (4 RCTs) | ⨁◯◯◯ VERY LOW a,b,c,d |
The risk in the exercise group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI); CI: Confidence interval; MD: Mean difference; RR: Risk ratio; GRADE Working Group grades of evidence. High certainty: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect. Explanations:
a. Half of the studies did not have blinded outcome assessment or did not have allocation concealment or the randomization method was unclear;
b. The time point of measurement was not long enough to support any conclusions;
c. Low number of events;
d. Small sample size;
e. The study had unblinded outcome assessment and did not have allocation concealment. The randomization method was unclear and there were incomplete outcome data.
GRADEpro-GDT judgment of the quality of the evidence: GRADE question: Should exercise be indicated for patients with aortic aneurysms at surveillance?
| Summary of findings: | |||||
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| Exercises compared to no exercise for aortic aneurysm patients at surveillance in long term (at 3 y) | |||||
| Patient or population: aortic aneurysm patients at surveillance in long term (at 3 y) | |||||
| Setting: | |||||
| Intervention: exercise | |||||
| Comparison: no exercise | |||||
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| Mortality follow up: mean 3 years | 0 per 100 | 0 per 100 (0 to 0) | not estimable | 140 (1 RCT) | ⨁◯◯◯ VERY LOW a,b,c,d,e |
| Aortic rupture follow up: mean 3 years | 0 per 100 | 0 per 100 | not estimable | 45 | ⨁◯◯◯ |
| (0 to 0) | (1 RCT) | VERY LOW a,b,d,e,f | |||
| Aneurysm growth rate | The mean aneurysm growth rate was 0.54 | The mean aneurysm growth rate in the exercise group was 0.06 lower (0.23 lower to 0.11 higher) | - | 45 | ⨁◯◯◯ |
| follow up: mean 3 years | (1 RCT) | VERY LOW a,b,c,d,e | |||
| Number of patients with at least one cardiovascular complication | 0 per 100 | 0 per 100 | not estimable | 45 | ⨁◯◯◯ |
| follow up: mean 3 years | (0 to 0) | (1 RCT) | VERY LOW a,b,c,d,e | ||
| Number of patients who reached threshold for surgery | 13 per 100 | 4 per 100 | RR 0.31 | 140 | ⨁◯◯◯ |
| follow up: mean 3 years | (1 to 15) | (0.09 to 1.11) | (1 RCT) | VERY LOW a,b,c,d,e | |
The risk in the exercise group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; MD: Mean difference; RR: Risk ratio. GRADE Working Group grades of evidence. High certainty: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect. Explanations:
a. The randomization method, allocation concealment, blinding of outcome assessment, and other sources of bias are unclear. There is a high risk of incomplete outcome data;
b. The intervention was performed in a very controlled setting, not applied to the usual patient;
c. There was only one study;
d. The sample size is too small to make a judgment;
e. The number of events were small;
f. Single study. Large number of patients lost to follow-up.
GRADEpro-GDT judgment of the quality of the evidence: GRADE question: Should exercise be indicated for patients with aortic aneurysms before surgery?
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| Mortality follow up: mean 30 days | 3 per 100 | 3 per 100 | RR 1.00 | 124 | ⨁◯◯◯ | Mortality was related to surgery. There was no mortality related to exercise. |
| (3 to 3) | (0.93 to 1.07) | (1 RCT) | VERY LOW a,b | |||
| Aortic rupture follow up: mean 30 days | 0 per 100 | 0 per 100 | not estimable | 124 | ⨁◯◯◯ | |
| (0 to 0) | (1 RCT) | VERY LOW a,b | ||||
| Aneurysm growth rate - not measured | - | - | - | - | - | |
| Number of patients with at least one cardiovascular complication follow up: mean 30 days | 23 per 100 | 8 per 100 | RR 0.36 | 124 | ⨁◯◯◯ | |
| (3 to 21) | (0.14 to 0.93) | (1 RCT) | VERY LOW a,b | |||
| Number of patients who reached threshold for surgery - not measured | - | - | - | - | - | |
The risk in the exercise group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; GRADE Working Group grades of evidence. High certainty: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect. Explanations:
a. Due to nature of intervention, it was impossible to blind participants and personnel;
b. Single study, low number of events
GRADEpro-GDT judgment of the quality of the evidence: GRADE question: Should exercise be indicated for patients with aortic aneurysms after surgery?
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| Mortality - not measured | - | - | - | - | - |
| Aortic rupture - not measured | - | - | - | - | - |
| Aneurysm growth rate - not measured | - | - | - | - | - |
| Number of patients with at least one cardiovascular complication - not measured | - | - | - | - | - |
| Number of patients who reached threshold for surgery - not measured | - | - | - | - | - |
The risk in the exercise group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI); CI: Confidence interval. GRADE Working Group grades of evidence. High certainty: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.
GRADEpro-GDT judgment of the quality of the evidence: GRADE question: Should exercise be indicated for patients with aortic aneurysms before and after surgery?
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| Mortality - not measured | - | - | - | - | - | |
| Aortic rupture - not measured | - | - | - | - | - | |
| Aneurysm growth rate - not measured | - | - | - | - | - | |
| Number of patients with at least one cardiovascular complication - not measured | - | - | - | - | - | |
| Number of patients who reached threshold for surgery - not measured | - | - | - | - | - | |
The risk in the exercise group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval. GRADE Working Group grades of evidence. High certainty: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.
Figure 1PRISMA flow chart for the review. This figure shows the PRISMA flow chart illustrating the processing of searching for, selecting, excluding, and including studies. There were three references from the same studies: two25,26 from Myers et al.11 and one27 from Barakat et al.,28 resulting in eight references from five original studies.
Studies and characteristics.
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| Kothmann et al. (2009) | Number of patients in exercise group: 20 |
| Number of patients in control group: 10 | |
| Age (mean): exercise group: 69.5 years, control group: 69.4 years | |
| Time of intervention: At surveillance | |
| Sex: 20 men and 5 women | |
| Interventions: | |
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| Outcomes: change in anaerobic threshold | |
| Follow-up: 7 weeks | |
| Tew et al. (2012) | Number of patients in exercise group: 14 |
| Number of patients in control group: 14 | |
| Age: exercise group: 71 ± 8 years, control group: 74 ± 6 years. | |
| Time of intervention: at surveillance | |
| Sex: male/female: Exercise group: 10/1. Control group: 11/3 | |
| Interventions: | |
| Borg perceived exhaustion scale at zones of 12 to
14 | |
| Outcomes: ** | |
| Follow-up: 12 weeks | |
| Myers et al. (2014) | Number of patients in exercise group: 72 |
| Number of patients in control group: 68 | |
| Age: exercise group: 71.8 ± 7 years, control group: 71.3 ± 8 years. | |
| Time of intervention: at surveillance | |
| Sex: exercise group: 92% men, control group: 93% men. | |
| Interventions: | |
| Borg perceived exhaustion scale at zones of 12 to
14 | |
| Outcomes: safety; aneurysm growth rates. | |
| Follow-up: up to 36 months | |
| Barakat et al. (2016) | Number of patients in exercise group: 62 |
| Number of patients in control group: 62 | |
| Age: exercise group: 73.8 years, control group: 72.9 years. | |
| Time of intervention: during preoperative period. | |
| Sex: exercise group: 6 women; control group: 7 women. | |
| Interventions: | |
| Outcomes: composite postoperative cardiac, renal
and postoperative respiratory complications; length of hospital stay, and
ITU stay, “ | |
| Follow-up: 12 weeks | |
| Wnuk et al. (2016) | Number of patients in exercise group: 44 (22 backward walking; 22 forward walking) |
| Number of patients in control group: 21 | |
| Age: exercise group: 71 ± 8 years, control group: 74 ± 6 years. | |
| Time of intervention: during postoperative period. | |
| Sex ratio: male/female: Exercise group: 10/1. Control group: 11/3. | |
| Interventions: postoperative backward walking training, and postoperative forward walking training. | |
| Outcomes: six minutes walking test; heart rate training; standard metabolic equivalent; FVC, FEV1, FEV1/FVC, PEF, hospital-stay. | |
| Follow-up: 7 days | |
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| Dronkers et al. (2008) | RCT comparing respiratory physical therapy with usual care in patients with an aortic aneurysm scheduled for surgery. Physical therapy was not considered to be exercise. |
| Nakayama et al. (2018) | Retrospective cohort comparing cardiac rehabilitation with usual care with a follow up of 3000 days. Not a clinical trial. |
| Main ID: JPRN-UMIN000028237 | |
| Hayashi et al. (2016) | Case-control study. Patients were allocated to fit or unfit groups according to physical capacity. |
| Bailey et al. (2018) | RCT evaluating effect of acute exercise on endothelial function in patients with abdominal aortic aneurysm. The study describes acute flow-mediated-dilatation and not the outcomes of the exercise over a long period as a necessity of treatment for the disease, so it was considered physical activity and not physical exercises. |
| Weston et al. (2017) | RCT assessing the accuracy of high-intensity interval training (HIT) in patients awaiting repair of large abdominal aortic aneurysms. |
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| ClinicalTrials.gov (2017) | As contacted by e-mail: NCT01805973 (14) has been changed to “The AAA Get fit trial”: |
| Randomized, parallel, blinded to assessors study:
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| ClinicalTrials.gov Identifier: NCT02997618 | |
| ClinicalTrials.gov (2017) | Randomized, parallel, open study: |
| ClinicalTrials.gov Identifier: NCT03064308 | |
| ClinicalTrials.gov (2017) | Randomized, parallel, blinded to
assessors study: |
| ClinicalTrials.gov Identifier: NCT02767518 | |
| Mosk 2017 | Non-randomized, two or more arms study: |
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| Main ID: NTR5932 |
Excluded studies: describes excluded studies and reasons for exclusion. Ongoing studies: describes ongoing studies and characteristics. Included studies: describes included studies and characteristics. AAA: Abdominal Aortic Aneurysm. AT: Anaerobic Threshold. APACHE II scores: Acute Physiology And Chronic Health Evaluation II. CEPET: Cardiopulmonary Exercise Test. FEV1: Forced Expiratory Volume in 1 second. FEV1/FVC: ratio of forced expiratory volume in one second to forced vital capacity. FVC: Functional Vital Capacity. HDU/ITU: High-dependency Unit/Intensive Care Unit. HIT: High-Intensity Interval Training. ITU: Intensive Care Unit. PEF: Peak Expiratory Flow. QoL: Quality of Life. RCT: Randomized Controlled Trial. VO2: rate of oxygen consumption during incremental exercise.
Text quoted from ClinicalTrials.gov36;
Text quoted from ClinicalTrials.gov37;
Text quoted from ClinicalTrials.gov38;
|| Text quoted from Mosk39;
Text quoted from Kothmann et al.29;
Text quoted from Tew et al.18;
Text quoted from Myers et al.11;
Text quoted from Barakat et al.28.
Risk of bias table with justifications.
| A) Clinical trials: | |
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| Barakat et al. | Quote: “ |
| Random sequence generation (selection bias) | |
| “Low risk” | Comment: randomization was described and seems to be appropriate. |
| Allocation concealment (selection bias) “Unclear risk” | Comment: not described |
| Blinding of participants and personnel (performance bias) – all-cause mortality | Quote: “ |
| “High risk” | Comment: due to the nature of the intervention, it is impossible to blind patients. |
| Blinding of participants and personnel (performance bias) – number of patients with aortic rupture. | Quote: “ |
| “High risk” | Comment: due to the nature of the intervention it is impossible to blind patients. |
| Blinding of participants and personnel (performance bias) – aneurysm growth | Quote: “ |
| “High risk” | Comment: due to the nature of the intervention it is impossible to blind patients. |
| Blinding of participants and personnel (performance bias) – quality of life | Not assessed |
| Blinding of participants and personnel (performance bias) – number of patients referred for surgery | Not assessed |
| Blinding of participants and personnel (performance bias) – peri-operative complications | Quote: “ |
| “High risk” | Comment: due to the nature of the intervention it is impossible to blind patients. |
| Há Blinding of participants and personnel (performance bias) – postoperative complications | Quote: “ |
| “High risk” | Comment: due to the nature of the intervention it is impossible to blind patients. |
| Blinding of participants and personnel (performance bias) – cardiovascular mortality | Quote: “ |
| “High risk” | Comment: due to the nature of the intervention it is impossible to blind patients. |
| Blinding of participants and personnel (performance bias) – hospital stay | Quote: “ |
| “High risk” | Comment: due to the nature of the intervention it is impossible to blind patients. |
| Blinding of participants and personnel (performance bias) – VEF1 | Not assessed |
| Blinding of outcome assessment (detection bias) – all-cause mortality | Quote: “ |
| “Low risk” | Comment: blinding of outcome assessment was described and seems to be appropriate |
| Blinding of outcome assessment (detection bias) – number of patients with aortic rupture | Quote: “ |
| “Low risk” | Comment: blinding of outcome assessment was described and seems to be appropriate |
| Blinding of outcome assessment (detection bias) – aneurysm growth | Quote: “ |
| “Low risk” | Comment: blinding of outcome assessment was described and seems to be appropriate |
| Blinding of outcome assessment (detection bias) – quality of life | Not assessed |
| Blinding of outcome assessment (detection bias) – number of patients referred for surgery | Not applicable |
| Blinding of outcome assessment (detection bias) – peri-operative complications | Quote: “ |
| “Low risk” | Comment: blinding of outcome assessment was described and seems to be appropriate |
| Blinding of outcome assessment (detection bias) – postoperative complications | Quote: “ |
| “Low risk” | Comment: blinding of outcome assessment was described and seems to be appropriate |
| Blinding of outcome assessment (detection bias) – cardiovascular mortality | Quote: “ |
| “Low risk” | Comment: blinding of outcome assessment was described and seems to be appropriate |
| Blinding of outcome assessment (detection bias) – hospital stay | Quote: “ |
| “Low risk” | Comment: blinding of outcome assessment was described and seems to be appropriate |
| Blinding of outcome assessment (detection bias) – VEF1 | Not assessed |
| Incomplete outcome data (attrition bias) – all-cause mortality | Quote: “ |
| “Low risk” | Comment: there were 8.8% losses from each group and they were explained. There were no other loses of follow up. |
| Incomplete outcome data (attrition bias) – number of patients with aortic rupture | Quote: “ |
| “Low risk” | Comment: there were 8.8% losses from each group and they were explained There were no other loses of follow up. |
| Incomplete outcome data (attrition bias) – aneurysm growth | Quote: “ |
| “Low risk” | Comment: there were 8.8% losses from each group and they were explained There were no other loses of follow up. |
| Incomplete outcome data (attrition bias) – quality of life | Not assessed |
| Incomplete outcome data (attrition bias) – number of patients referred for surgery | Not applicable |
| Incomplete outcome data (attrition bias) – peri-operative complications | Quote: “ |
| “Low risk” | Comment: there were 8.8% losses from each group and they were explained There were no other loses of follow up. |
| Incomplete outcome data (attrition bias) – postoperative complications | Quote: “ |
| “Low risk” | Comment: there were 8.8% losses from each group and they were explained There were no other loses of follow up. |
| Incomplete outcome data (attrition bias) – cardiovascular mortality | Quote: “ |
| “Low risk” | Comment: there were 8.8% losses from each group and they were explained There were no other loses of follow up. |
| Incomplete outcome data (attrition bias) – hospital stay | Quote: “ |
| “Low risk” | Comment: there were 8.8% losses from each group and they were explained There were no other loses of follow up. |
| Incomplete outcome data (attrition bias) – VEF1 | Not assessed |
| Selective reporting (reporting bias) | Comment: A protocol has been published: NCT01062594. All proposed outcomes were reported. |
| “Low risk” | Comment: there were no imbalances between groups. There were two different interventions (endovascular and open surgery). The numbers were balanced between groups. |
| Other bias | |
| “Low risk” | |
| Kothmann et al. | |
| Random sequence generation (selection bias) | Quote: |
| “Low risk” | Comment: Randomization was described and seems to be appropriate. |
| Allocation concealment (selection bias) | Comment: not described |
| “Unclear risk” | |
| Blinding of participants and personnel (performance bias) – all-cause mortality | Comment: no information provided. Probably not done due to the nature of the intervention. |
| “High risk” | |
| Blinding of participants and personnel (performance bias) – number of patients with aortic rupture. | Comment: no information provided. Probably not done due to the nature of the intervention. |
| “High risk” | |
| Blinding of participants and personnel (performance bias) – aneurysm growth | Not assessed |
| Blinding of participants and personnel (performance bias) – quality of life | Not assessed |
| Blinding of participants and personnel (performance bias) – number of patients referred for surgery | Comment: no information provided. Probably not done due to the nature of the intervention. |
| “High risk” | |
| Blinding of participants and personnel (performance bias) – peri-operative complications | Not applicable |
| Blinding of participants and personnel (performance bias) – postoperative complications | Not applicable |
| Blinding of participants and personnel (performance bias) – cardiovascular mortality | Comment: no information provided. Probably not done due to the nature of the intervention. |
| “High risk” | |
| Blinding of participants and personnel (performance bias) – hospital stay | Not applicable |
| Blinding of participants and personnel (performance bias) – VEF1 | Not assessed |
| Blinding of outcome assessment (detection bias) – all-cause mortality | Quote: |
| “Low risk” | Comment: blinding of outcome assessment properly described. |
| Blinding of outcome assessment (detection bias) – number of patients with aortic rupture | Quote: |
| “Low risk” | Comment: blinding of outcome assessment properly described. |
| Blinding of outcome assessment (detection bias) – aneurysm growth | Not assessed |
| Blinding of outcome assessment (detection bias) – quality of life | Not assessed |
| Blinding of outcome assessment (detection bias) – number of patients referred for surgery | Quote: |
| “Low risk” | Comment: blinding of outcome assessment properly described. |
| Blinding of outcome assessment (detection bias) – peri-operative complications | Not applicable |
| Blinding of outcome assessment (detection bias) – postoperative complications | Not applicable |
| Blinding of outcome assessment (detection bias) – cardiovascular mortality | Quote: |
| “Low risk” | Comment: blinding of outcome assessment properly described. |
| Blinding of outcome assessment (detection bias) – hospital stay | Not applicable |
| Blinding of outcome assessment (detection bias) – VEF1 | Not assessed |
| Incomplete outcome data (attrition bias) – all-cause mortality | “ |
| “Unclear risk” | Comment: (There was 15% losses from the intervention group and 20% from the control group. We are not sure about the extent to which this could affect the results). |
| Incomplete outcome data (attrition bias) – number of patients with aortic rupture | “ |
| “Unclear risk” | Comment: (There was 15% losses from the intervention group and 20% from the control group. We are not sure about the extent to which this could affect the results). |
| Incomplete outcome data (attrition bias) – aneurysm growth | Not assessed |
| Incomplete outcome data (attrition bias) – quality of life | Not assessed |
| Incomplete outcome data (attrition bias) – number of patients referred for surgery | “ |
| “unclear risk” | Comment: There was 15% losses from the intervention group and 20% from the control group. We are not sure to what extent this could affect the results. |
| Incomplete outcome data (attrition bias) – peri-operative complications | Not applicable |
| Incomplete outcome data (attrition bias) – postoperative complications | Not applicable |
| Incomplete outcome data (attrition bias) – cardiovascular mortality | “ |
| “Unclear risk” | Comment: There was 15% losses from the intervention group and 20% from the control group. We are not sure to what extent this could affect the results. |
| Incomplete outcome data (attrition bias) – hospital stay | Not applicable |
| Incomplete outcome data (attrition bias) – VEF1 | Not assessed |
| Selective reporting (reporting bias) | Comment: All the proposed outcomes were reported. |
| “Low risk” | |
| Other bias | Comment: There is an uncertainty about the balance between groups at baseline, since no p value was provided. We are not sure to what extent this could affect the results. |
| “Unclear risk” | |
| Myers et al. | |
| Random sequence generation (selection bias) | Quote: “ |
| “Unclear risk” | Comment: Not described. |
| Allocation concealment (selection bias) | Comment: not described |
| “Unclear risk” | |
| Blinding of participants and personnel (performance bias) – all-cause mortality | Comment: not stated. Probably not done since the nature of intervention precluded this masking |
| “High risk” | |
| Blinding of participants and personnel (performance bias) – number of patients with aortic rupture. | Comment: not stated. Probably not done since the nature of intervention precluded this masking |
| “High risk” | |
| Blinding of participants and personnel (performance bias) – aneurysm growth | Comment: not stated. Probably not done since the nature of intervention precluded this masking |
| “High risk” | |
| Blinding of participants and personnel (performance bias) – quality of life | Not assessed |
| Blinding of participants and personnel (performance bias) – number of patients referred for surgery | Comment: not stated. Probably not done since the nature of intervention precluded this masking |
| “High risk” | |
| Blinding of participants and personnel (performance bias) – peri-operative complications | Not assessed |
| Blinding of participants and personnel (performance bias) – postoperative complications | Not assessed |
| Blinding of participants and personnel (performance bias) – cardiovascular mortality | Comment: not stated. Probably not done since the nature of intervention precluded this masking |
| “High risk” | |
| Blinding of participants and personnel (performance bias) – hospital stay | Not assessed |
| Blinding of participants and personnel (performance bias) – VEF1 | Not assessed |
| Blinding of outcome assessment (detection bias) – all-cause mortality | Quote: |
| “Unclear risk” | Comment: no information provided for data assessors |
| Blinding of outcome assessment (detection bias) – number of patients with aortic rupture | Quote: Quote: |
| “Unclear risk” | Comment: no information provided for data assessors |
| Blinding of outcome assessment (detection bias) – aneurysm growth | Quote: |
| “Unclear risk” | Comment: no information provided for data assessors |
| Blinding of outcome assessment (detection bias) – quality of life | Not assessed |
| Blinding of outcome assessment (detection bias) – number of patients referred for surgery | Quote: |
| “Unclear risk” | Comment: no information provided for data assessors |
| Blinding of outcome assessment (detection bias) – peri-operative complications | Not assessed |
| Blinding of outcome assessment (detection bias) – postoperative complications | Not assessed |
| Blinding of outcome assessment (detection bias) – cardiovascular mortality | Quote: |
| “Unclear risk” | Comment: no information provided for data assessors |
| Blinding of outcome assessment (detection bias) – hospital stay | Not assessed |
| Blinding of outcome assessment (detection bias) – VEF1 | Not assessed |
| Incomplete outcome data (attrition bias) – all-cause mortality | Quote: |
| “High risk” | Comment: There were 19% losses in one year. Additionally, at the end of follow-up, there were 39 losses from the intervention group and 36 from the control group. The reasons for these losses are unclear. |
| Incomplete outcome data (attrition bias) – number of patients with aortic rupture | Quote: |
| “High risk” | Comment: There were 19% losses in one year. Additionally, at the end of follow-up, there were 39 losses from the intervention group and 36 from the control group. The reasons for these losses are unclear. |
| Incomplete outcome data (attrition bias) – aneurysm growth | Quote: |
| “High risk” | Comment: There were 19% losses in one year. Additionally, at the end of follow-up, there were 39 losses from the intervention group and 36 from the control group. The reasons for these losses are unclear. |
| Incomplete outcome data (attrition bias) – quality of life | Not assessed |
| Incomplete outcome data (attrition bias) – number of patients referred for surgery | Quote: |
| “High risk” | Comment: There were 19% losses in one year. Additionally, at the end of follow-up, there were 39 losses from the intervention group and 36 from the control group. The reasons for these losses are unclear. |
| Incomplete outcome data (attrition bias) – peri-operative complications | Not assessed |
| Incomplete outcome data (attrition bias) – postoperative complications | Not assessed |
| Incomplete outcome data (attrition bias) – cardiovascular mortality | Quote: |
| “High risk” | Comment: There were 19% losses in one year. Additionally, at the end of follow-up, there were 39 losses from the intervention group and 36 from the control group. The reasons for these losses are unclear. |
| Incomplete outcome data (attrition bias) – hospital stay | Not assessed |
| Incomplete outcome data (attrition bias) – VEF1 | Not assessed |
| Selective reporting (reporting bias) | Quote: Protocol available at Clinicaltrials.gov, identifier: NCT00349947. |
| “Low risk” | Comment: protocol described. All proposed outcomes were reported |
| Other bias | Comment: There was an
“ |
| “Unclear risk” | We are not sure to what extent this could affect the results. |
| Tew et al. | |
| Random sequence generation (selection bias) | Quote: |
| “Unclear risk” | Comment: unclear information |
| Allocation concealment (selection bias) | Quote: |
| “Unclear risk” | Comment: unclear information |
| Blinding of participants and personnel (performance bias) – all-cause mortality | Quote: |
| “High risk” | Comment: The nature of the intervention precluded this masking |
| Blinding of participants and personnel (performance bias) – number of patients with aortic rupture. | Quote: |
| “High risk” | Comment: The nature of the intervention precluded this masking |
| Blinding of participants and personnel (performance bias) – aneurysm growth | Quote: |
| “High risk” | Comment: The nature of the intervention precluded this masking |
| Blinding of participants and personnel (performance bias) – quality of life | Quote: |
| “High risk” | Comment: The nature of the intervention precluded this masking |
| Blinding of participants and personnel (performance bias) – number of patients referred for surgery | Not assessed |
| Blinding of participants and personnel (performance bias) – peri-operative complications | Not applicable |
| Blinding of participants and personnel (performance bias) – postoperative complications | Not applicable |
| Blinding of participants and personnel (performance bias) – cardiovascular mortality | Quote: |
| “High risk” | Comment: The nature of the intervention precluded this masking |
| Blinding of participants and personnel (performance bias) – hospital stay | Not applicable |
| Blinding of participants and personnel (performance bias) – VEF1 | Not assessed |
| Blinding of outcome assessment (detection bias) – all-cause mortality | Quote: “ |
| “High risk” | Comment: There was no blinding |
| Blinding of outcome assessment (detection bias) – number of patients with aortic rupture | Quote: “ |
| “High risk” | Comment: There was no blinding |
| Blinding of outcome assessment (detection bias) – aneurysm growth | Quote: “ |
| “High risk” | Comment: There was no blinding |
| Blinding of outcome assessment (detection bias) – quality of life | Quote: |
| “High risk” | Comment: There was no blinding |
| Blinding of outcome assessment (detection bias) – number of patients referred for surgery | Not assessed |
| Blinding of outcome assessment (detection bias) – peri-operative complications | Not applicable |
| Blinding of outcome assessment (detection bias) – postoperative complications | Not applicable |
| Blinding of outcome assessment (detection bias) – cardiovascular mortality | Quote: |
| “High risk” | Comment: There was no blinding |
| Blinding of outcome assessment (detection bias) – hospital stay | Not applicable |
| Blinding of outcome assessment (detection bias) – VEF1 | Not assessed |
| Incomplete outcome data (attrition bias) – all-cause mortality | Quote: |
| “Unclear risk” | Comment: There were about 20% of losses from the intervention group, with reasons provided. We are not sure to what extent this could affect the results. |
| Incomplete outcome data (attrition bias) – number of patients with aortic rupture | Quote: |
| “Unclear risk” | Comment: There were about 20% of losses from the intervention group, with reasons provided. We are not sure to what extent this could affect the results. |
| Incomplete outcome data (attrition bias) – aneurysm growth | Quote: |
| “Unclear risk” | Comment: There were about 20% of losses from the intervention group, with reasons provided. We are not sure to what extent this could affect the results. |
| Incomplete outcome data (attrition bias) – quality of life | Quote: |
| “Unclear risk” | Comment: There were about 20% of losses from the intervention group, with reasons provided. We are not sure to what extent this could affect the results. |
| Incomplete outcome data (attrition bias) – number of patients referred for surgery | Not assessed |
| Incomplete outcome data (attrition bias) – peri-operative complications | Not applicable |
| Incomplete outcome data (attrition bias) – postoperative complications | Not applicable |
| Incomplete outcome data (attrition bias) – cardiovascular mortality | Quote: |
| “Unclear risk” | Comment: There were about 20% of losses from the intervention group, with reasons provided. We are not sure to what extent this could affect the results. |
| Incomplete outcome data (attrition bias) – hospital stay | Not applicable |
| Incomplete outcome data (attrition bias) – VEF1 | Not assessed |
| Selective reporting (reporting bias) | Quote: |
| “Low risk” | Comment: there is a protocol and it seems to be appropriate. All proposed outcomes were reported. |
| Does not
show the data for the quality of life outcome | |
| Other bias | Comment: There is an uncertainty about the balance between groups at baseline, since no p value was provided. We are not sure to what extent this could affect the results. |
| “Unclear risk | |
| Wnuk et al. | |
| Random sequence generation (selection bias) | Quote: |
| “Low risk” | Comment: randomization considered done and apparently appropriate. |
| Allocation concealment (selection bias) | Comment: not stated |
| “Unclear risk” | |
| Blinding of participants and personnel (performance bias) – all-cause mortality | Not assessed |
| Blinding of participants and personnel (performance bias) – number of patients with aortic rupture. | Not applicable |
| Blinding of participants and personnel (performance bias) – aneurysm growth | Not applicable |
| Blinding of participants and personnel (performance bias) – quality of life | Not assessed |
| Blinding of participants and personnel (performance bias) – number of patients referred for surgery | Not applicable |
| Blinding of participants and personnel (performance bias) – peri-operative complications | Not applicable |
| Blinding of participants and personnel (performance bias) – postoperative complications | Not assessed |
| Blinding of participants and personnel (performance bias) – cardiovascular mortality | Not assessed |
| Blinding of participants and personnel (performance bias) – hospital stay | Quote: “ |
| “High risk” | Comment: not blinded |
| Blinding of participants and personnel | Quote: “ |
| (performance bias) – VEF1 | Comment: not blinded |
| “High risk” | |
| Blinding of outcome assessment (detection bias) – all-cause mortality | Not assessed |
| Blinding of outcome assessment (detection bias) – number of patients with aortic rupture | Not applicable |
| Blinding of outcome assessment (detection bias) – aneurysm growth | Not applicable |
| Blinding of outcome assessment (detection bias) – quality of life | Not assessed |
| Blinding of outcome assessment (detection bias) – number of patients referred for surgery | Not applicable |
| Blinding of outcome assessment (detection bias) – peri-operative complications | Not applicable |
| Blinding of outcome assessment (detection bias) – postoperative complications | Not assessed |
| Blinding of outcome assessment (detection bias) – cardiovascular mortality | Not assessed |
| Blinding of outcome assessment (detection bias) – hospital stay | Quote: described as a single blinded study. Replied by e-mail
09/27/2017: |
| “Low risk” | Comment: blinding of outcome assessment was described and seems to be appropriate. |
| Blinding of outcome assessment (detection bias) – VEF1 | Quote: described as a
single blinded study. Replied by e-mail 09/27/2017: |
| “Low risk” | Comment: blinding of outcome assessment was described and seems to be appropriate. |
| Incomplete outcome data (attrition bias) – all-cause mortality | Not assessed |
| Incomplete outcome data (attrition bias) – number of patients with aortic rupture | Not applicable |
| Incomplete outcome data (attrition bias) – aneurysm growth | Not applicable |
| Incomplete outcome data (attrition bias) – quality of life | Not assessed |
| Incomplete outcome data (attrition bias) – number of patients referred for surgery | Not applicable |
| Incomplete outcome data (attrition bias) – peri-operative complications | Not applicable |
| Incomplete outcome data (attrition bias) – postoperative complications | Not assessed |
| Incomplete outcome data (attrition bias) – cardiovascular mortality | Not assessed |
| Incomplete outcome data (attrition bias) – hospital stay | Comment: there were 27.41% dropouts and we do not what the impact of this would be on results and conclusions. |
| “Unclear risk” | |
| Incomplete outcome data (attrition bias) – VEF1 | Comment: there were 27.41% dropouts and we do not what the impact of this would be on results and conclusions. |
| “Unclear risk” | |
| Selective reporting (reporting bias) | Comment: the proposed outcomes were described and seem to be appropriate. |
| “Low risk” | |
| Other bias | Comment: describes balance between groups at baseline. No other source of bias detected. |
| “Low risk” |
Not assessed: The reduction in bias is possible since the authors report the necessary information to avoid bias but it was not described in the study; Not applicable: not possible within the study protocol; Not stated: not described.
Figure 2Number of patients referred for surgery at any time during surveillance. This figure shows patients referred for surgery at any time during the surveillance period. They were described at 12 weeks (1.2.1) and at 12 months (1.2.2). M-H, Mantel–Haenszel; Random, random-effects model; CI, confidence interval; Events, number of patients referred for surgery; Total, total number of patients; Total (95% CI), effect size at 95% confidence interval.
Figure 3Exercise time during surveillance. (A) Exercise time during surveillance at 12 weeks (exercise vs. no exercise). (B) Exercise time during surveillance at 12 months (exercise vs. no exercise). IV, inverse variance; Random, random-effects model; CI, confidence interval; Total, total number of patients; Total (95% CI), effect size at 95% confidence interval.
Figure 4Change in anaerobic threshold and peak VO2 during surveillance. (A) Change in total anaerobic threshold values at 7 and 12 weeks during surveillance (exercise vs. no exercise). (B) Peak VO2 during surveillance at 7 and 12 weeks (exercise vs. no exercise). IV, inverse variance; Random, random-effects model; CI, confidence interval; Total, total number of patients; Total (95% CI), effect size at 95% confidence interval.
Figure 5Thirty-day mortality after surgery in patients in the preoperative study. This figure compares 30-day mortality after surgery in patients in the exercise and no exercise groups during the preoperative period. EVAR, endovascular aneurysm repair. Comparison 2 involves the subset treated with EVAR (2.5.1) and the subset treated with open surgery (2.5.2). M-H: Mantel–Haenszel; Random, random-effects model; CI, confidence interval; Events, number of deaths up to 30 days after surgery; Total, total number of patients; Total (95% CI), effect size at 95% confidence interval.