Motedayen 2014.
Study characteristics | ||
Methods | Study design
Study dates
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Participants | Study characteristics
Baseline characteristics
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Interventions | Intervention classification
Intervention group
Control group
Co‐interventions
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Outcomes | Outcomes reported
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Notes | Additional information
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Sequence generation methods were not reported in sufficient detail to permit judgement |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment was not reported in sufficient detail to permit judgement |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported. However, interventions were different and participants and/or investigators could be aware of the treatment assigned |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "The Fatigue Severity Scale (FSS) questionnaire was completed by the subjects prior to the study and at the end of the first and the second months." Comment: The outcomes were assessed with an appropriate measure, without differences between groups. However, subjective measures were used, it was not stated whether outcomes were assessed without knowledge of treatment allocation, and knowledge of treatment assignment may have influenced reporting. Participant beliefs about the superiority/inferiority of either intervention could have influenced their assessment of the outcome, but there was no evidence that this was likely. Other objective outcomes were assessed |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Initially, 75 patients were assigned to the experimental and control groups; nine patients were excluded from the study because of death, transplantation, transportation from the health centre, or refusing to do the exercises regularly due to fatigue, boredom, and sleeplessness on the night before dialysis. Therefore, the findings of the study were extracted from the information of two 33‐patient groups." Comment: Overall, 66/75 participants completed the study (>5% lost to follow‐up; possible differences between groups were not reported). Reasons for discontinuations seemed to be not related to the treatment allocation |
Selective reporting (reporting bias) | High risk | Information about the protocol and the statistical analysis plan were not reported. Fatigue was reported using multiple eligible outcome measurements (scales, time points). Fatigue was reported in a format that was extractable for meta‐analysis. All outcomes that should be addressed (fatigue, cardiovascular disease, and death) were not reported |
Other bias | Low risk | There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding was unlikely to influence the data analysis and conflicts of interest was not reported |