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

Schardong 2021.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 8 weeks

  • Time frame: October 2017 to September 2018

Participants Study characteristics
  • Setting: single centre (HD outpatient of Santa Clara hospital at ISCMPA)

  • Country: Brazil

  • Inclusion criteria: CKF on HD for ≥ 3 months, of both sexes; 18 and 80 years; URR ≥ 65% and weekly dialysis frequency of 3 times/week were included in the study

  • Exclusion criteria: cognitive dysfunction that prevented performing the evaluations; inability to understand the informed consent form; epidermal lesions at the site of PBM application, patients with active carcinoma, stroke sequelae, recent acute MI (2 months); uncontrolled hypertension (SBP > 230 mm Hg and DBP > 120 mm Hg); IV grade heart failure according to the NYHA or decompensated; unstable angina; deep venous thrombosis in the lower limb; incapacitating osteoarticular or musculoskeletal disease, uncontrolled diabetes (glycaemia > 300 mg/dL), febrile state and/or infectious disease, and smokers


Baseline characteristics
  • Number (analysed/randomised): intervention group (14/17); control group (14/16)

  • Mean age ± SD (years): intervention group (53.0 ± 17); control group (58.1 ± 16.9)

  • Sex (M/F): intervention group (9/5); control group (7/7)

  • Dialysis type: HD

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

  • Comorbidities

    • CVD: not reported

    • Diabetes: intervention group (2/14); control group (4/14)

    • Hypertension: intervention group (13/14); control group (13/14)

    • Depression (clinician diagnosis): not reported

Interventions Intervention classification
  • Non‐pharmacological intervention

  • Indication: study targeting fatigue


Intervention group
  • Photobiomodulation therapy


Control group
  • No intervention


Co‐interventions
  • Not reported

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

  • Vital signs

  • Adverse events

  • Muscle strength

  • Muscle structure

  • Functional capacity

    • 6MWT

  • Pain

  • Fatigue

  • HRQoL

    • EQ‐5D (Appendix 3)

      • Mobility

      • Personal care

      • Habitual activities

      • Pain/discomfort

      • Anxiety/depression

    • KDQOL‐SF (Appendix 3)

Notes Additional information
  • Funding: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) – Financial code 001

  • Conflicts of interest/disclosures: none

  • Trial registration identification number: NCT03250715

  • A priori published protocol was reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomization occurred through the www.random.org website."
Allocation concealment (selection bias) Low risk Quote: "The sequence of numbers was generated by a researcher “blinded” to the study, and it was kept confidential until the beginning of the intervention to guarantee the concealment of the allocation."
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 Low risk Quote: "All analyses were conducted by a researcher blind to the study procedures (randomisation, evaluations, and intervention)."
Comment: 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 Quote: "Thirty‐six patients with CKF on HD were evaluated for eligibility and possible admission into the study. Twenty‐eight met the inclusion criteria and finalized the protocol."
Comment: 14/17 participants in the intervention group and 14/16 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 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 data analysis and interpretation. No other source of bias were apparent