Jansen 2013.
Methods | Parallel‐group RCT | |
Participants |
Sample size Intervention group: 17 boys with DMD, control group: 13 boys with DMD Inclusion criteria Boys were included if they needed more than 5 s to rise from the floor, were not able to rise from the floor, were not able to cycle without electric assistance, or needed a wheelchair to move over a long (> 500 m) distance. Wheelchair‐dependent boys were eligible if they were able to touch the top of their head with both hands or were able to use a hand‐operated wheelchair. Exclusion criteria Exclusion criteria were as follows: age < 6 years, a clinical cardiomyopathy, and other disabling diseases influencing mobility Baseline demographics At baseline, 8 boys were ambulant and 9 were wheelchair‐dependent in the intervention group, compared with 10 and 3 in the control group, respectively (P = .098). In the intervention group, 14 boys used corticosteroids compared with 9 in the control group. |
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Interventions | Aerobic exercise vs no training Type of training and exercise Assisted bicycle home training programme Intensity 15 min cycling with arms and legs using a mobility trainer with electrical motor support Frequency 5 days/week Setting At home or at school, depending on the preferences of the participants (the Netherlands) Duration Session: 15 min. Programme: 24 weeks Supervision Parents and/or teachers were instructed to assist the boys. Training intensity and posture were monitored and if necessary adjusted by the primary investigator |
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Outcomes |
Primary MFM and the 6‐min Cycling Test Secondary PEDI, timed tests (rise from floor, 10‐m run, 9‐hole peg test), muscle strength, passive joint ROM, and quantitative muscle ultrasound. Bilaterally muscle strength of the hip extensors, knee extensors, ankle dorsiflexors, shoulder abductors, and elbow extensors (MRC score), signs of overexertion by means of a questionnaire Time‐points measured Outcomes were assessed at baseline, after 4 weeks, 8 weeks, 32 weeks and 56 weeks. |
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Dates | Boys were recruited January 2009‐January 2010 | |
Funding/ declarations of interest |
Funding Study author(s) "disclosed receipt of the following financial support for the research, authorship, and/or publication of this article. This study was financially supported by a grant from the patient organisation Duchenne Parent Project." Declarations of interest Study author(s) "declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article." |
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Notes | ‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "Stratified randomisation (ambulant vs wheelchair‐dependent) was used to allocate participants to either the intervention or the control group in a 2:1 ratio. Two boys were not randomised, but directly allocated to the intervention group, because the study duration was ending. Comment: no published information on the sequence generation. Study author (Jansen) informed us that the randomisation list was provided by the statistician. |
Allocation concealment (selection bias) | Low risk | Comment: no published information on the allocation concealment. Study author (Jansen) informed us that an independent secretary allocated the boys to one of both groups. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: participants and outcome assessor were not blinded to treatment allocation but had no information about previous test results at each assessment. 2 boys were originally allocated to the intervention group, but replaced to the control group within 2 weeks after trying the intervention". |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: participants and outcome assessor were not blinded to treatment allocation but had no information about previous test results at each assessment. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: one boy discontinued the training and assessment after 12 weeks and was excluded from the analysis, so the analysis was not ITT. |
Selective reporting (reporting bias) | Low risk | Comment: no evidence found for selective reporting |
Other bias | Low risk | Comment: no risk of bias from other sources detected |