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. 2023 Aug 31;2023(8):CD013074. doi: 10.1002/14651858.CD013074.pub2

Salehi 2020.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 4 months

  • Time frame: not reported

Participants Study characteristics
  • Setting: single centre (HD units of Shafa Hospital and Jawad Al Aemeh Center, affiliated with Kerman University of Medical Sciences)

  • Country: Iran

  • Inclusion criteria: ≥ 18 years; receiving HD for at least 3 months; without problems in their legs

  • Exclusion criteria: contraindication of exercise according to doctors' perspective; diabetic foot; PTH > 1000 ng/L; not exercising for more than 3 sessions


Baseline characteristics
  • Number (analysed/randomised): intervention group (20/27); control group (17/27)

  • Mean age ± SD (years): intervention group (57.8 ± 9.17); control group (54.65 ± 10.02)

  • Sex (M/F): intervention group (13/7); control group (13/4)

  • Dialysis type: HD

  • Mean dialysis vintage ± SD (years): intervention group (3.6 ± 3.2); control group (3.1 ± 1.7)

  • Comorbidities

    • CVD: not reported

    • Diabetes: not reported

    • Hypertension: not reported

    • Depression (clinician diagnosis): not reported

Interventions Intervention classification
  • Non‐pharmacological intervention

  • Indication: study targeting fatigue


Intervention group
  • Mini‐bikes for 20 min twice/week for 3 months


Control group
  • No intervention for 3 months


Co‐interventions
  • Not reported

Outcomes Outcomes reported
  • Fatigue outcome measures used: validation data available

  • Death

  • Fatigue

    • MFI‐20 (Appendix 3)

      • Fatigue

      • Physical fatigue

      • Decline in activity

      • Decline in motivation

      • Mental fatigue

Notes Additional information
  • Funding: none

  • Conflicts of interest/disclosures: none

  • Trial registration identification number: IRCT20180314039100N1

  • A priori published protocol was reported

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 Fatigue was 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. However, subjective and objective outcomes were assessed
Incomplete outcome data (attrition bias)
All outcomes High risk 20/27 participants in the intervention group and 17/27 participants in the control group completed the study (> 5% lost to follow‐up). There were differences between groups. Reasons for discontinuation were reported
Selective reporting (reporting bias) High risk Information about the protocol and the statistical analysis plan were reported. Fatigue was assessed using multiple eligible outcome measurements (scales and time points). Fatigue at the end of treatment 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. There was no source of funding or conflict of interests. No other source of bias were apparent