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

Suzuki 2018.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 8 weeks

  • Time frame: October 2013 to September 2015

Participants Study characteristics
  • Setting: single centre (Jikei University Katsushika Medical Center in Japan)

  • Country: Japan

  • Inclusion criteria: ≥ 20 years; dialysis duration for a minimum of 2 months with adequate dialysis delivery; stable medical condition

  • Exclusion criteria: severe or symptomatic cardiovascular disease; orthopaedic complaints interfering with physical function test; severe dementia; implanted medical devices contraindicating MRI scans


Baseline characteristics
  • Number (analysed/randomised): intervention group (13/15); control group (13/14)

  • Mean age ± SD (years): intervention group (66.2 ± 12.8); control group (65.± 1 8.1)

  • Sex (M/F): intervention group (14/1); control group (13/1)

  • Dialysis type: HD

  • Mean dialysis vintage ± SD (years): intervention group (2.3 ± 2.0); control group (2.5 ± 2.0)

  • Comorbidities

    • CVD: not reported

    • Diabetes: intervention group (7/13); control group (10/13)

    • Hypertension: intervention group (11/13); control group (13/13)

    • Depression (clinician diagnosis): not reported

Interventions Intervention classification
  • Non‐pharmacological intervention

  • Indication: study targeting fatigue


Intervention group
  • Electrical muscle stimulation


Control group
  • No intervention


Co‐interventions
  • Not reported

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

  • Isometric knee extensor strength

  • Physical function

    • Timed up‐and‐go test

  • HRQoL

    • SF‐8: assessed at baseline and end of treatment

  • Laboratory parameters (albumin, Hb, lipids, IGF‐1): assessed at baseline and end of treatment

  • BP: assessed at baseline and end of treatment)

  • Dry weight: assessed at baseline and end of treatment

  • Adverse events

Notes Additional information
  • Funding: This study received no external funding

  • Conflicts of interest/disclosures: none

  • Trial registration identification number: UMIN000012061

  • A priori published protocol was reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "A total of 29 HD patients were eligible for inclusion in the study and were randomly assigned to either the EMS or the control (no training) group by simple random allocation
(drawing lots)."
Comment: 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 Quote: "This was a prospective, open‐label, randomised controlled trial."
Comment: An open‐label study is considered as high risk of bias
Blinding of outcome assessment (detection bias)
All outcomes High risk The outcomes (including vitality) 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. However, objective and subjective outcomes were assessed
Incomplete outcome data (attrition bias)
All outcomes High risk Quote: "The EMS group included 14 men and 1 woman, while the control group included 13 men and 1 woman. Thirteen (86.7%) participants in the EMS group completed EMS training. The reasons for failure to complete training were hospitalisation before intervention (n51) and dropout due to discomfort of the wet electrode bands (n51). Likewise, 13 (92.9%) participants in the control group completed the protocol. One participant in the control group withdrew consent to join the study. The final analyses included 13 patients in each group."
Comment: 13/15 participants in the intervention group and 13/14 participants in the control group completed the study (> 5% lost to follow‐up, with difference between group). Reasons for discontinuations were reported
Selective reporting (reporting bias) High risk Information about the protocol were reported. Vitality was reported using multiple eligible outcome measurements (scales, time points). Vitality 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 authors did not have conflicts of interest. No other source of bias were apparent