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

Soliman 2015.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 8 weeks

  • Time frame: June 2014 to November 2014

Participants Study characteristics
  • Setting: single centre

  • Country: Egypt

  • Inclusion criteria: male and female; > 18 years; minimum HD vintage of 3 months, stable on HD; no recent hospitalisation; no acute or chronic medical conditions that would make exercise training potentially hazardous or primary outcomes impossible to assess; receiving HD 3 times/week, for 3 or 4 hours/session, having no problems in arteriovenous fistulas, adequate dialysis therapy (Kt/V > 1.2); high‐flux dialysis membrane was in use only those patients who used bicarbonate solution were included; unintentional low dietary protein intake < 1 g/kg of ideal weight/day for at least 2 months, unintentional low dietary energy intake < 30 kcal/kg of ideal weight/day for at least 2 months

  • Exclusion criteria: uncontrolled hypertension; congestive heart failure; arrhythmia requiring treatment; unstable angina; major valvular heart disease; MI, significant arteriosclerosis; risk of fracture; musculoskeletal disorders; change in the resting ECG; severe aortic stenosis; suspected or known dissecting aneurysm; myocarditis; participation in another trial; inadequate dialysis Kt/V < 1.2; Hb < 10 g/dL unstable on dialysis


Baseline characteristics
  • Number (analysed/randomised): intervention group (18/23); control group (12/17)

  • Age (years): not reported

  • Sex (M/F): intervention group (8/10); control group (6/6)

  • 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
  • Range of motion exercise


Control group
  • No intervention


Co‐interventions
  • Not reported

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

  • Fatigue

  • Serum electrolyte level, including phosphate and potassium, and calcium: baseline, 1 and 2 months

  • Hb: baseline, 1 and 2 months

  • BP: baseline, 1 and 2 months

  • Other laboratory parameters (urea, creatinine): baseline, 1 and 2 months

Notes Additional information
  • Funding: not reported

  • Conflicts of interest/disclosures: none

  • Trial registration identification number: not reported

  • A priori published protocol was 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. No imbalance between intervention groups was apparent
Allocation concealment (selection bias) Unclear risk Method of allocation concealment was not reported in sufficient detail to permit judgement. No imbalance between intervention groups was apparent
Blinding of participants and personnel (performance bias)
All outcomes High risk Not reported. However, interventions were different and investigators/participants 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, objective and subjective outcomes were assessed
Incomplete outcome data (attrition bias)
All outcomes High risk Quote: "40 met the inclusion criteria and agreed to participate within the proposed study, 10 patients were excluded from the study due to death, transplantation or refusing to try to do exercise regularly due to fatigue. Of those, 30 patients completed the study, 18 in experimental group and twelve in control group."
Comment: 18/23 participants in the intervention group and 12/17 participants in the control group completed the study (> 5% lost to follow‐up). There were differences between groups. Reasons for discontinuation were provided
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 Unclear risk There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding was not reported