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

Duggal 2019.

Study characteristics
Methods Study design

  • Parallel RCT


Study dates

  • Duration of follow‐up: 4 weeks

  • Time frame: September 2017 to April 2018
Participants Study characteristics

  • Setting: multicentre (18 centres)

  • Country: USA

  • Inclusion criteria: HD patients with recovery time 6 hours or more at baseline; aged 18 to 89 years; able to answer survey questions in English or Spanish, HD ≥ 3 times/week who reported post‐dialysis fatigue ≥ 6 hours at baseline

  • Exclusion criteria: Kt/V < 1.3 for those dialysing 3 times/week, or Kt/V < 2.1 for those dialysing 4 times/week so clearance targets could still be met despite blood flow rate reduction; pregnant, breastfeeding, or considering pregnancy; planned change in dialysis duration or timing, or if the primary nephrologist had a medical objection to the patient’s involvement


Baseline characteristics

  • Number (analysed/randomised): intervention group (44/52); control group (42/50)

  • Mean age ± SD (years): intervention group (64.2 ± 13.1); control group (64.4 ± 11.9)

  • Sex (M/F): intervention group (31/21); control group (34/26)

  • Dialysis type: HD

  • Mean dialysis vintage ± SD (years): intervention group (4.5 ± 3.6); control group (6.0 ± 6.7)

  • Comorbidities

    • CVD: not reported

    • Diabetes: intervention group (34/52); control group (31/50)

    • Hypertension: not reported

    • Depression (clinician diagnosis): not reported
Interventions Intervention classification

  • Non‐pharmacological intervention

  • Indication: study reporting fatigue


Intervention group

  • Blood flow rate reduction of 100 mL/min to a minimum of 300 mL/min


Control group

  • Standard care


Co‐interventions

  • Not reported
Outcomes Outcomes reported

  • Fatigue outcome measures used: validation data not available

  • Reduction in dialysis recovery time

  • Hospitalisation

  • Fatigue

  • QoL

    • LEVIL survey: baseline and weeks 1, 2, 3, 4 (Appendix 3)

      • Pain

      • Feeling washed out or drained

      • Sleep quality

      • Shortness of breath

      • Appetite

      • Well‐being
Notes Additional information

  • Funding: Satellite Healthcare Research Fellowship award

  • Conflicts of interest/disclosures: W.H., M.R., S.S., G.A., and B.S. are employees of Satellite Healthcare

  • Trial registration identification number: not reported

  • A priori published protocol: IRB Protocol SR064RT
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Patients were randomised in a 1:1 manner to intervention or control arms using a computer‐generated sequence of randomly permuted blocks."
Comment: Comupter generation is considered at low risk of bias
Allocation concealment (selection bias) Low risk Quote: "The random allocation sequence was generated by statisticians who were not involved in the survey process."
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "Single‐blinded." "Patients were blinded to group assignment."
Comment: A single blinded study is considered as high risk of bias
Blinding of outcome assessment (detection bias)
All outcomes High risk The outcomes were assessed with an appropriate measure, without differences between groups. However, objective and subjective outcomes were assessed
Incomplete outcome data (attrition bias)
All outcomes High risk Quote: "There were 102 patients enrolled in the study. A total of 86 (84.3%) of those subjects completed the study. Of
those in the control group, 42 (84.0%) completed the study, and 44 (84.6%) of those in the intervention group
completed the study. Causes of discontinuation are noted."
Comment: 44/52 participants in the intervention group and 42/50 participants in the control group completed the study (> 5% lost to follow‐up). There were differences between groups and reasons for discontinuation were provided
Selective reporting (reporting bias) High risk Information about the protocol and the statistical analysis plan were reported. Regarding fatigue, it was not reported if multiple eligible outcome measurements (scales and time points) were pre‐specified. It was unclear if the reported approach to analysing this outcome was pre‐specified or influenced by the results. Fatigue at the end of treatment was not reported in a format that was not 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. No other source of bias were apparent