Wiesinger 1998a.
| Methods | Parallel‐group RCT | |
| Participants |
Sample size Intervention group: 2 adults with PM, 5 adults with DM, control group: 2 adults with PM, 5 adults with DM Inclusion criteria Established DM or PM with a disease duration of > 6 months, clinical activity defined as the presence of proximal muscle weakness, and/or the elevation of CK levels above the upper limit of normal on ≥ 3 consecutive observations during the preceding 3‐month period, the drug therapy had to be stable for at least 3 months before the start of the training programme Exclusion criteria Clinically manifest pulmonary or cardiac disorders, inclusion body myositis, fever, neoplasms, physical inability to exercise, or increase in muscle destruction during the past 3 months before the start of the training programme, as indicated by at least a 50% increase in CK levels over the baseline value Baseline demographics Mean age participants control group: 40 years, mean age participants training group: 56 years. Female/male ratio control group: 5/2, female/male ratio training group: 4/3. |
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| Interventions | Aerobic exercise training vs no training Type of training and exercise Endurance bicycle training, endurance step aerobics Intensity Bicycle training: 30 min, slowly increased on an individual basis. Resistance was increased until a heart rate of 60% of maximum. Step aerobics: 30 min Frequency During the first 2 weeks, twice weekly, during the remaining 4 weeks, 3 times weekly Setting University Hospital of Vienna, Austria Duration Session: 60 min. Programme: 6 weeks Muscle groups Not applicable Supervision Supervised by a physiotherapist |
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| Outcomes | No primary outcome or secondary outcomes defined. Study outcomes: ADL score, peak isometric torque of knee extensors and hip flexors, peak oxygen consumption and CK and aldolase levels Time‐points measured Before and after 6 weeks of control or training period |
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| Dates | Study dates not reported | |
| Funding/ declarations of interest | None reported | |
| Notes | Outcomes were not presented separately for DM and PM | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Distinct randomisation lists were used". Comment: there was no information about the generation of the list. It is not clear what is meant by "distinct randomisation lists" |
| Allocation concealment (selection bias) | Unclear risk | Comment: there was no published information on the method of allocation concealment |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded for group assignment, as it is impossible to blind exercise training compared to no exercise training. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "Muscle strength assessments were carried out by the same person who was unaware of the group to which the individual patients belonged". Comment: there was no published information about blinding of the assessor of the other measurements |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: complete follow‐up of all participants |
| Selective reporting (reporting bias) | High risk | Comment: no primary or secondary outcomes were defined. Outcomes were also not clearly specified and reported |
| Other bias | Low risk | Comment: no risk of bias from other sources detected |