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. 2019 Dec 6;2019(12):CD003907. doi: 10.1002/14651858.CD003907.pub5

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
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.
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
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
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