| Literature DB >> 35738643 |
Varsamo Antoniou1, Andrew Xanthopoulos2, Gregory Giamouzis2, Constantinos Davos3, Ladislav Batalik4,5, Vasileios Stavrou6, Konstantinos I Gourgoulianis6, Eleni Kapreli1, John Skoularigis2, Garyfallia Pepera7.
Abstract
INTRODUCTION: Exercise-based cardiac rehabilitation (CR) is a beneficial tool for the secondary prevention of cardiovascular diseases with, however, low participation rates. Telerehabilitation, intergrading mobile technologies and wireless sensors may advance the cardiac patients' adherence. This study will investigate the efficacy, efficiency, safety and cost-effectiveness of a telerehabilitation programme based on objective exercise telemonitoring and evaluation of cardiorespiratory fitness. METHODS AND ANALYSIS: A supervised, parallel-group, single-blind randomised controlled trial will be conducted. A total of 124 patients with coronary disease will be randomised in a 1:1 ratio into two groups: intervention telerehabilitation group (TELE-CR) (n=62) and control centre-based cardiac rehabilitation group (CB-CR) (n=62). Participants will receive a 12-week exercise-based rehabilitation programme, remotely monitored for the TELE-CR group and standard supervised for the CB-CR group. All participants will perform aerobic training at 70% of their maximal heart rate, as obtained from cardiopulmonary exercise testing (CPET) for 20 min plus 20 min for strengthening and balance training, three times per week. The primary outcomes will be the assessment of cardiorespiratory fitness, expressed as peak oxygen uptake assessed by the CPET test and the 6 min walk test. Secondary outcomes will be the physical activity, the safety of the exercise intervention (number of adverse events that may occur during the exercise), the quality of life, the training adherence, the anxiety and depression levels, the nicotine dependence and cost-effectiveness. Assessments will be held at baseline, end of intervention (12 weeks) and follow-up (36 weeks). ETHICS AND DISSEMINATION: The study protocol has been reviewed and approved by the Ethics Committee of the University of Thessaly (1108/1-12-2021) and by the Ethics Committee of the General University Hospital of Larissa (3780/31-01-2022). The results of this study will be disseminated through manuscript publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT05019157. © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.Entities:
Keywords: cardiology; rehabilitation medicine; telemedicine
Mesh:
Year: 2022 PMID: 35738643 PMCID: PMC9226468 DOI: 10.1136/bmjopen-2021-059945
Source DB: PubMed Journal: BMJ Open ISSN: 2044-6055 Impact factor: 3.006
Figure 1Flow chart of the study design. CAD, coronary artery disease; CR, cardiac rehabilitation; HADS, Hospital Anxiety and Depression Scale; HR, heart rate; HRQoL, health-related quality of life; IPAQ, International Physical Activity Questionnaire; 6MWT, 6 min walk test.
Summary of study schedule
| Enrolment | Baseline (A0) | End of intervention (A12) | Follow-up (A36) | |
| Eligibility screening | X | |||
| Informed consent | X | |||
| Randomisation | X | |||
| Allocation | X | |||
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| Centre-based CR |
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| Telerehabilitation |
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| Demographic characteristics | X | |||
| Spirometry, TTE | X | |||
| Strength evaluation test | X | |||
| Cardiac biomarkers (BNP, NT-proBNP, troponins, creatine kinase) | X | X | ||
| CPET–6MWT | X | X | X | |
| HRQoL | X | X | X | |
| HADS | X | X | X | |
| IPAQ | X | X | X | |
| FTND | X | X | X | |
| Cost analysis | X | |||
| Training adherence | X | |||
BNP, B-type natriuretic peptide; CPET, cardiopulmonary exercise testing; CR, cardiac rehabilitation; FTND, Fagerstrom Test for Nicotine Dependence; HADS, Hospital Anxiety and Depression Scale; HRQoL, health-related quality of life; IPAQ, International Physical Activity Questionnaire; 6MWT, 6 min walk test; NT-proBNP, N-terminal pro-brain natriuretic peptide; TTE, transthoracic echocardiography.
Cardiac risk stratification
| Low risk | Moderate risk | High risk |
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Absence of angina or other symptoms (eg, unusual shortness of breath, mild headache or dizziness). Functional capacity >7 METs, left ventricular ejection fraction (LVEF) ≥50%. Absence of arrhythmia at rest. Absence of depression. |
Presence of angina or other symptoms (eg, unusual shortness of breath, mild headache or dizziness, dizziness occurring at high levels of exercise ≥7 METs). Mild to moderate silent ischaemia (ST eruption <2 mm). Functional capacity >5 METs. LVEF=40%–49%. |
Presence of arrhythmias. Presence of angina or other symptoms (eg, unusual breathlessness, mild headache or dizziness, dizziness occurring at high levels of exercise <5 METs). Silent ischaemia (ST stroke ≥2 mm). Presence of abnormal haemodynamics during exercise (reduction of BP) or postexercise hypotension. LVEF<40%. |
BP, blood pressure; METs, metabolic equivalents.
CB-CR exercise programme
| Warm-up | |
| Cycling or mild treadmill walking | 5 min |
| Stretching activities Upper back Chest Lower back, waist mobility Calf Hamstring Quadriceps | 5 min |
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| Aerobic training | |
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Cycling or treadmill walking | Exercise with an intensity of 70% of the patients’ maximal heart rate (HRmax) at a level of 12/20–14/20 of Borg scale |
| Strengthening training | |
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Biceps curls Shoulder press Triceps Lateral fly Front deltoid raise Mini squats Hamstring curls Plantar flex Side leg raise | 12 repetitions |
| Balance training | |
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Standing on one foot Walking heel to toe Reaching front Lateral Back | Starting with the patient’s own body weight. |
| Duration 40 min | |
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Cycling or mild treadmill walking Moving hands slowly Stretching exercises | 10 min |
CB-CR, centre-based cardiac rehabilitation group.
TELE-CR exercise programme
| Warm-up | |
| Marching on the spot | 5 min |
| Stretching activities Upper back Chest Lower back, waist mobility Calf Hamstring Quadriceps | 5 min |
|
| |
| Aerobic training | |
|
Box stepping Knee raises only With hand to opposite knee Hand to opposite ankle Knee bends only With swinging arms With reaching arms Side steps Just tapping With half-arm lift Reaching over Marching Heal lift only With arms moving | 10 repetitions |
| Strengthening training | |
|
Biceps curls Shoulder press Triceps Lateral fly Front deltoid raise Mini squats Hamstring curls Plantar flex Side leg raise | 12 repetitions |
| Balance training | |
|
Standing on one foot Walking heel to toe Reaching Front Lateral Back | Starting with the patient’s own body weight |
| Duration 40 min | |
|
| |
|
Marching on the spot gently Moving hands slowly Stretching exercises | 10 min |
TELE-CR, telerehabilitation group.