Skip to main content
. 2023 Aug 31;2023(8):CD013074. doi: 10.1002/14651858.CD013074.pub2

Motedayen 2014.

Study characteristics
Methods Study design
  • Parallel RCT (author reported that the study was a controlled trial)


Study dates
  • Duration of follow‐up: 2 months

  • Time frame: not reported

Participants Study characteristics
  • Setting: multicentre (Baqiyatallah Hospital and Labbafinejad Hospital, Tehran)

  • Country: Iran

  • Inclusion criteria: undergoing HD 3 times/week for at least 3 months who were capable of learning during the exercises

  • Exclusion criteria: patients participating in the regular exercise program in the preceding 6 months; medical prohibition from the exercise; history of ischaemic heart disease; third‐degree congestive heart failure; unstable angina; kidney transplant; high BP (≥ 180/110 mm Hg); low BP (≤ 90 mm Hg); reluctance to continue participating in the exercises


Baseline characteristics
  • Number (analysed/randomised): overall (66/75); intervention group (33/not reported); control group (33/not reported)

  • Mean age ± SD (years): overall (56.75 ± 11.91)

  • Sex (M/F): intervention group (22/11); control group (16/17)

  • Dialysis type: HD

  • Dialysis vintage (years) (mean ± SD): not reported

  • 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
  • Intradialytic physical and mental exercises for 2 months


Control group
  • No intervention


Co‐interventions
  • Not reported

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

  • Fatigue

    • FSS (Appendix 3): assessed at baseline, and at months 1 and 2

  • Death: assessed until the end of treatment

Notes Additional information
  • Funding: This paper was derived from the thesis and approved by Nursing School Board of Examiners in Baqiyatallah University of Medical Sciences. The special thanks go to Baqiyatallah Hospital Nephrology and Urology Research Center for its financial support

  • Conflicts of interest/disclosures: not reported

  • Trial registration identification number: not reported

  • A priori published protocol: not 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 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