| Literature DB >> 36231316 |
Aiwei Wang1,2, Danran Bu3,4, Siyue Yu5, Yan Sun2, Jingjing Wang6, Tinky Chin Ting Lee7, Julien S Baker2,7, Yang Gao2,7.
Abstract
Children with intellectual disability (ID) are more vulnerable to health conditions than their typically developing peers. Evidence of effective interventions is scarce. A randomized controlled trial was conducted in 30 overweight and obese children with intellectual disability (ID) in China to evaluate a 12-week school-based physical activity intervention for obesity, health-related physical fitness (HRPF), and blood pressure. The intervention consisted of 24 physical activity (PA) sessions (2 sessions/week, 60 min/session), with exercise intensity progressively increasing from a moderate level to a vigorous level. All participants were followed up for 12 weeks after the intervention period to evaluate sustained effects. Outcomes were repeatedly measured at baseline, after the intervention, and after follow-up. The intervention was effective in reducing some obesity-related outcomes (including weight and body mass index) and improving some HRPF-related outcomes (including the 6 min walk test and the 30 s sit-to-stand test), with the significant effects being sustained after the 12-week follow-up. No effect was observed on blood pressure. The findings of this study contribute to the development and implementation of PA interventions to reduce obesity and improve HRPF in children with ID.Entities:
Keywords: China; blood pressure; children; exercise; health-related fitness; intellectual disability; intervention; obesity; overweight; physical activity; randomized controlled trial (RCT)
Mesh:
Year: 2022 PMID: 36231316 PMCID: PMC9564506 DOI: 10.3390/ijerph191912015
Source DB: PubMed Journal: Int J Environ Res Public Health ISSN: 1660-4601 Impact factor: 4.614
Equations for calculating target exercise heart rate [21].
| No. | Equation |
|---|---|
| (1) | Exercise HR 1 (beats/min) = Target% × HRR 2 + HRrest 3 |
| (2) | HRR (beats/min) = HRmax − HRrest |
| (3) | HRmax
4 (beats/min) = 210 − 0.56 × age (in years) − 15.5 (Down syndrome) |
Note. 1 HR, heart rate; 2 HRR, heart rate reserve; 3 HRrest, resting heart rate; 4 HRmax, maximal heart rate.
Figure 1Participant flow diagram in CONSORT format.
Participant characteristics at baseline.
| Variable | Total | IG 1 | CG 2 |
|
|---|---|---|---|---|
|
| 14.17 ± 0.45 | 14.60 ± 2.20 | 13.73 ± 1.44 | 0.212 |
| 0.215 | ||||
|
| 26.30 ± 2.80 | 26.37 ± 2.74 | 26.24 ± 2.95 | 0.745 |
| 1.000 | ||||
|
| ||||
| - Autism Spectrum Disorder | 1.000 | |||
| - Down Syndrome | 0.598 | |||
|
| ||||
| - 1 | 7 (23.3) | 4 (26.7) | 3 (20.0) | 0.923 |
| - 2 | 8 (26.7) | 4 (26.7) | 4 (26.7) | |
| - 3 | 7 (23.3) | 4 (26.7) | 3 (20.0) | |
| - 4 | 8 (26.7) | 3 (20.0) | 5 (33.3) |
Note. 1 IG, intervention group; 2 CG, wait-list control group; 3 To detect between-group differences, independent sample t-test was performed for continuous variables and Fisher’s exact test was performed for categorical variables; 4 SD, standard deviation.
Within-group differences in obesity-related outcomes.
| Outcome | Change from T1 1 to T2 2 | Change from T1 to T3 3 | Change from T2 to T3 | |||
|---|---|---|---|---|---|---|
| Mean Difference (95%CI) 4 |
| Mean Difference (95%CI) |
| Mean Difference (95%CI) |
| |
Note. 1 T1, pre-intervention; 2 T2, post-intervention; 3 T3, follow-up; 4 95%CI, 95% confidence interval; 5 one-way repeated measure ANOVA was performed to detect within-group differences, and post-hoc analysis with Bofferoni correction was employed to test significance of the changes from T1 to T2, T1 to T3, and T2 to T3; 6 IG, intervention group; 7 CG, wait-list control group; 8 BMI, body mass index; bold text indicates significant results.
Between-group differences in obesity-related outcomes.
| Outcome | IG 1 (n = 15) | CG 2 (n = 15) | Adjusted Difference 4 (95%CI) 5 |
| Partial η2 |
|---|---|---|---|---|---|
|
| |||||
|
| |||||
Note. 1 IG, intervention group; 2 CG, wait-list control group; 3 SD, standard deviation; 4 Adjusted difference, the difference of the intervention group relative to the wait-list control group in ANCOVA, adjusted for covariates (baseline values were adjusted in the between-group difference at T2; baseline values and changes in puberty stage were adjusted in the between-group difference at T3); 5 95%CI, 95% confidence interval; 6 BMI, body mass index; bold text indicates significant results.
Figure 2Changes in obesity-related outcomes across the three-time points.
Within-group differences in HRPF-related outcomes.
| Outcome | Change from T1 1 to T2 2 | Change from T1 to T3 3 | Change from T2 to T3 | |||
|---|---|---|---|---|---|---|
| Mean Difference (95%CI) 4 |
| Mean Difference (95%CI) |
| Mean Difference (95%CI) |
| |
Note.1 T1, pre-intervention; 2 T2, post-intervention; 3 T3, follow-up; 4 95%CI, 95% confidence interval; 5 one-way repeated measure ANOVA was performed to detect within-group differences, and post-hoc analysis with Bofferoni correction was employed to test significance of the changes from T1 to T2, T1 to T3, and T2 to T3; 6 6MWT, six-minute walk test; 7 IG, intervention group; 8 CG, wait-list control group; bold text indicates significant results.
Between-group differences in HRPF-related outcomes.
| Outcome | IG 1 (n = 15) | CG 2 (n = 15) | Adjusted Difference 4 (95%CI) 5 |
| Partial |
|---|---|---|---|---|---|
|
| |||||
|
| |||||
Note.1 IG, intervention group; 2 CG, wait-list control group; 3 SD, standard deviation; 4 Adjusted difference, the difference of the intervention group relative to the wait-list control group in ANCOVA, adjusted for covariates (baseline values were adjusted in the between-group difference at T2; baseline values and changes in puberty stage were adjusted in the between-group difference at T3); 5 95%CI, 95% confidence interval; 6 6MWT, six-minute walk test; bold text indicates significant results.
Figure 3Changes in HRPF-related outcomes across the three-time points.
Within-group differences in blood pressure.
| Outcome | Change from T1 1 to T2 2 | Change from T1 to T3 3 | Change from T2 to T3 | |||
|---|---|---|---|---|---|---|
| Mean Difference (95%CI) 4 |
| Mean Difference (95%CI) |
| Mean Difference (95%CI) |
| |
Note.1 T1, pre-intervention; 2 T2, post-intervention; 3 T3, follow-up; 4 95%CI, 95% confidence interval; 5 one-way repeated measure ANOVA was performed to detect within-group differences, and post-hoc analysis with Bofferoni correction was employed to test significance of the changes from T1 to T2, T1 to T3, and T2 to T3; 6 IG, intervention group; 7 CG, wait-list control group.
Between-group differences in blood pressure.
| Outcome | IG 1 (n = 15) | CG 2 (n = 15) | Adjusted Difference 4 (95%CI) 5 |
| Partial η2 |
|---|---|---|---|---|---|
Note.1 IG, intervention group; 2 CG, wait-list control group; 3 SD, standard deviation; 4 Adjusted difference, the difference of the intervention group relative to the wait-list control group in ANCOVA, adjusted for covariates (baseline values were adjusted in the between-group difference at T2; baseline values and changes in puberty stage were adjusted in the between-group difference at T3); 5 95%CI, 95% confidence interval.
Figure 4Changes in blood pressure across the three-time points.
CONSORT 2010 checklist.
| Section/Topic | Item No | Checklist Item | Reported on Page No |
|---|---|---|---|
|
| |||
| 1a | Identification as a randomised trial in the title | P1. Title | |
| 1b | Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) | P1. Abstract | |
|
| |||
| Background and objectives | 2a | Scientific background and explanation of rationale | P1–2. Introduction |
| 2b | Specific objectives or hypotheses | P1–2. Introduction | |
|
| |||
| Trial design | 3a | Description of trial design (such as parallel, factorial) including allocation ratio | P2. Study design and participant |
| 3b | Important changes to methods after trial commencement (such as eligibility criteria), with reasons | P2. Study design and participant | |
| Participants | 4a | Eligibility criteria for participants | P2. Study design and participant |
| 4b | Settings and locations where the data were collected | P2. Study design and participant | |
| Interventions | 5 | The interventions for each group with sufficient details to allow replication, including how and when they were actually administered | P3. Intervention |
| Outcomes | 6a | Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed | P3–4. Measurements |
| 6b | Any changes to trial outcomes after the trial commenced, with reasons | N/A | |
| Sample size | 7a | How sample size was determined | P2. Study design and participant |
| 7b | When applicable, explanation of any interim analyses and stopping guidelines | N/A | |
| Randomisation: | |||
| Sequence generation | 8a | Method used to generate the random allocation sequence | P2. Study design and participant |
| 8b | Type of randomisation; details of any restriction (such as blocking and block size) | P2. Study design and participant | |
| Allocation concealment mechanism | 9 | Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned | P2. Study design and participant |
| Implementation | 10 | Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | P2. Study design and participant |
| Blinding | 11a | If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how | P2. Study design and participant |
| 11b | If relevant, description of the similarity of interventions | N/A | |
| Statistical methods | 12a | Statistical methods used to compare groups for primary and secondary outcomes | P4. Data analysis |
| 12b | Methods for additional analyses, such as subgroup analyses and adjusted analyses | P4. Data analysis | |
|
| |||
| Participant flow (a diagram is strongly recommended) | 13a | For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome | P4–5. Results |
| 13b | For each group, losses and exclusions after randomisation, together with reasons | P4–5. Results | |
| Recruitment | 14a | Dates defining the periods of recruitment and follow-up | P4–5. Results |
| 14b | Why the trial ended or was stopped | N/A | |
| Baseline data | 15 | A table showing baseline demographic and clinical characteristics for each group |
|
| Numbers analysed | 16 | For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups |
|
| Outcomes and estimation | 17a | For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) | P6–13. Results |
| 17b | For binary outcomes, presentation of both absolute and relative effect sizes is recommended | N/A | |
| Ancillary analyses | 18 | Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory | N/A |
| Harms | 19 | All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) | N/A |
|
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| Limitations | 20 | Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | P16. Discussion |
| Generalisability | 21 | Generalisability (external validity, applicability) of the trial findings | P16–17. Conclusion |
| Interpretation | 22 | Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | P14–16. Discussion |
|
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| Registration | 23 | Registration number and name of trial registry | P2. Study design and participants |
| Protocol | 24 | Where the full trial protocol can be accessed, if available | P18. References |
| Funding | 25 | Sources of funding and other support (such as supply of drugs), role of funders | P17. Funding |
Lifestyle confounders of the participants at T1, T2, and T3.
| Variable, n (%) | T1 1 | T2 2 | T3 3 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Total, | IG 4, n = 15 | CG 5, n = 15 |
| Total, N = 30 | IG, n = 15 | CG, n = 15 |
| Total, N = 30 | IG, n = 15 | CG, n = 15 |
| |
Note.1 T1, pre-intervention; 2 T2, post-intervention; 3 T3, follow-up; 4 IG, intervention group; 5 CG, wait-list control group; 6 To detect between-group differences, Fisher’s exact test was performed for all lifestyle confounders (categorical variables); 7 PA, physical activity; 8 MVPA, moderate to vigorous physical activity; Bold text indicates significant results.
Attendance rate of the 12-week physical activity program.
| Training Period | Session | Except Number of Attendants | Actual Number of Attendants | Attendance Rate |
|---|---|---|---|---|
|
| 1 | 15 | 15 | 100.0 |
| 2 | 15 | 14 | 93.3 | |
| 3 | 15 | 15 | 100.0 | |
| 4 | 15 | 15 | 93.3 | |
| 5 | 15 | 14 | 93.3 | |
| 6 | 15 | 13 | 86.7 | |
| 7 | 15 | 15 | 100.0 | |
| 8 | 15 | 15 | 100.0 | |
|
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|
| 9 | 15 | 14 | 93.3 |
| 10 | 15 | 13 | 86.7 | |
| 11 | 15 | 15 | 100.0 | |
| 12 | 15 | 15 | 100.0 | |
| 13 | 15 | 15 | 100.0 | |
| 14 | 15 | 14 | 93.3 | |
| 15 | 15 | 14 | 93.33 | |
| 16 | 15 | 15 | 100.0 | |
|
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|
| 17 | 15 | 15 | 100.0 |
| 18 | 15 | 15 | 100.0 | |
| 19 | 15 | 15 | 100.0 | |
| 20 | 15 | 15 | 100.0 | |
| 21 | 15 | 14 | 93.3 | |
| 22 | 15 | 15 | 100.0 | |
| 23 | 15 | 14 | 93.3 | |
| 24 | 15 | 15 | 100.0 | |
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Parental feedback on the effectiveness, usefulness, and satisfaction of the 12-week physical activity programme (n = 15).
| How Do You Think about the 12-week PA Program? | Strongly Disagree | Disagree | Not Sure | Agree | Strongly Agree |
|---|---|---|---|---|---|
|
| |||||
|
It is effective for reducing my child’s weight. | 0 | 2 | 1 | 10 (66.7) | 2 |
|
It is effective for improving my child’s health-related physical fitness level. | 0 | 0 | 3 | 11 (73.3) | 1 |
|
It is effective for reducing my child’s blood pressure. | 0 | 0 | 4 | 7 | 1 |
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It is important to reduce my child’s weight. | 0 | 1 | 1 | 11 (73.3) | 2 |
|
It is important to improve my child’s health-related physical fitness level. | 0 | 0 | 3 | 11 (73.3) | 1 |
|
It is important to reduce my child’s blood pressure. | 0 | 0 | 2 | 12 (80.0) | 1 |
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Overall, I am satisfied with the 12-week PA program. | 0 | 0 | 0 | 12 (80.0) | 3 |
Teachers’ feedback on the effectiveness, arrangement, and staffing of the 12-week physical activity programme (n = 4).
| How Do You Think about the 12-week PA program? | Strongly Disagree | Disagree | Not Sure | Agree | Strongly Agree |
|---|---|---|---|---|---|
|
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|
It is effective for reducing students’ weight. | 0 | 0 | 0 | 0 | 4 |
|
It is effective for improving students’ health-related physical fitness level. | 0 | 0 | 0 | 0 | 4 |
|
It is effective for reducing students’ blood pressure. | 0 | 0 | 0 | 0 | 4 |
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I’m satisfied with the whole arrangement of the PA sessions. | 0 | 0 | 0 | 0 | 4 |
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I’m satisfied with the whole arrangement of the measurements. | 0 | 0 | 0 | 1 | 3 |
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I’m satisfied with the staffing of the PA sessions. | 0 | 0 | 0 | 0 | 4 |
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I’m satisfied with the staffing of the measurements. | 0 | 0 | 0 | 1 | 3 |
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If possible, our school would like to continue participate it. | 0 | 0 | 0 | 0 | 4 |
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I would like to recommend it to other special schools. | 0 | 0 | 0 | 0 | 4 |