Habers 2016.
Methods | Parallel‐group RCT | |
Participants |
Inclusion criteria People were eligible if they were diagnosed with juvenile DM by a paediatric rheumatologist/immunologist according to the Bohan and Peter criteria, and were aged 8‐18 years at time of enrolment in this study. Exclusion criteria People were excluded if: medical status contraindicated exercise testing; the patient (or the parents or caregivers) had an insufficient understanding of the Dutch language; a medical event that might interfere with the outcome of testing and/or the trial was present (such as a planned surgery); the rheumatologist advised against participation based on a recent relapse or the concurrent existence of other disease; and/or the person was already very active in sports without any restrictions and without a subjectively diminished exercise capacity. Baseline demographics The median (range) age at inclusion was 12.3 years and 62% were girls. The median (range) age at diagnosis was 7.1 years. The median (range) disease duration at inclusion was 4.4 years. Sample size Intervention group: 14 children and adolescents with juvenile DM, control group: 12 children and adolescents with juvenile DM |
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Interventions | Strength training and aerobic exercise training vs no training Type of training and exercise Interval treadmill training, strength training, at home Intensity Aerobic training: individualised work rate, 30 min leg exercise on an ergo cycle, 65%‐90% of the peak heart rate alternated with short periods of low‐intensity exercise (50%‐60% of peak heart rate) Strength training: the intensity of the strength training was set by time (20‐30 s for every single exercise), performing as many repetitions in 20‐30 s. Frequency 2‐3 times/week, total of 32 training sessions Setting At home (the Netherlands) Duration Session: 40 min‐60 min. Programme: 12 weeks Muscle groups Proximal muscle groups Supervision Parents were present for support and motivation. Every 2 weeks, a researcher or physiotherapist conducted a home visit for supervision, adjustments and motivation. |
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Outcomes |
Primary Aerobic exercise capacity Secondary Isometric muscle strength of knee and hip flexors and extensors, perception of fatigue, distance walked in a 6‐min walk test, quality of life, muscle function (distance standing long jump, amount of sit‐ups and push‐ups, time wall sit, time V‐up, muscle soreness, perception of fatigue (PedsQOL multidimensional fatigue scale), pain (VAS) Time‐points measured Before and after 12 weeks of control or training period and after 12 weeks of follow‐up |
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Dates | Participants were included from 2012‐2014 | |
Funding/ declarations of interest |
Funding: "This work was supported by the Dutch Arthritis Foundation [11‐I‐202]." Disclosure statement: study authors have declared no conflicts of interest |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "This was a multicenter (four academic hospitals), stratified (age and gender), parallel‐group study (...) with a balanced randomisation performed by an independent and blinded person using computer generated lists of random numbers with randomly varying block sizes (2 or 4)". |
Allocation concealment (selection bias) | Low risk | Quote: "This was a multicenter (four academic hospitals), stratified (age and gender), parallel‐group study (...) with a balanced randomisation performed by an independent and blinded person using computer generated lists of random numbers with randomly varying block sizes (2 or 4)". Comment: probably done |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible: intervention was training vs no training |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The researchers performing the assessments, as well as those charged with data analyses were blinded to treatment allocation". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "all participants were included in the groups to which they were randomly assigned and the researchers made efforts too obtain outcome data for all participants, even if the intervention was not completed". Comment: 3 participants stopped the intervention prematurely. |
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 |