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

Figueiredo 2018.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 16 weeks

  • Time frame: January 2015 to December 2015

Participants Study characteristics
  • Setting: not reported

  • Country: Brazil

  • Inclusion criteria: > 18 years; not receiving anti‐inflammatory or antiallergic medication; under HD treatment 3 times/week for at least 3 months, and with arteriovenous fistula for HD access

  • Exclusion criteria: any contraindication to physical exercise or inability to perform the functional tests


Baseline characteristics
  • Number (analysed/randomised): intervention group 1 (10/11); intervention group 2 (10/13); intervention group 3 (11/13)

  • Mean age (years) (SD not reported): intervention group 1 (52.8); intervention group 2 (49.5); intervention group 3 (45.2)

  • Sex (M/F): intervention group 1 (7/4); intervention group 2 (10/3); intervention group 3 (9/4)

  • Dialysis type: HD

  • Mean dialysis vintage (years) (SD not reported): intervention group 1 (4.4); intervention group 2 (3.0); intervention group 3 (4.9)

  • Comorbidities

    • CVD: not reported

    • Diabetes: intervention group 1 (2/11); intervention group 2 (2/13); intervention group 3 (3/13)

    • Hypertension: not reported

    • Depression (clinician diagnosis): not reported

Interventions Intervention classification
  • Non‐pharmacological intervention

  • Indication: study targeting fatigue


Intervention group 1
  • Inspiratory muscle training at 50% of MIP for 8 weeks


Intervention group 2
  • Aerobic training low intensity for 8 weeks


Intervention group 3
  • Combined training (inspiratory muscle training + aerobic training) for 8 weeks


Co‐interventions
  • The dialysis prescription and medication therapy remained unchanged during the study

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

  • Functional capacity (incremental shuttle walk test): assessed at baseline, weeks 8 and 16

  • MIP and lower limbs strength (sit‐to‐stand test of 30 seconds): assessed at baseline, weeks 8 and 16

  • Plasma levels of IL‐6, soluble tumour necrosis factor receptor 1 and 2, adiponectin, resistin and leptin, redox status parameters: assessed at baseline, weeks 8 and 16

  • Anthropometric/physical parameters (weight, BMI, waist circumference and body fat percentage): assessed at baseline, weeks 8 and 16

  • QoL

    • KDQOL‐SF: assessed at baseline, weeks 8 and 16

Notes
  • Funding: FundacËão de Amparo à Pesquisa do Estado de Minas Gerais, APQ‐03093‐15;

  • Conflicts of interest/disclosures: none

  • Trial registration identification number: Registro Brasileiro de Ensaios clõÂnicos RBR‐4hv9rs

  • A priori published protocol was 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) Low risk Quote: "Randomisation was performed using individual allocation codes placed within opaque, sealed envelopes by a person having no contact with the participants."
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 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/investigators 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. It was not stated if the monitoring group was blinded to the treatment assigned. However, objective and subjective outcomes were assessed.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Quote: "Intention‐to‐treat."
Comment: 10/11 participants in the intervention group 1 (IMT), 10/13 participants in the intervention group 2 (at), and 11/13 participants in the intervention group3 3 (combination) completed the study. However ITT was performed.
Selective reporting (reporting bias) Low risk Information about the protocol and the statistical analysis plan were reported. Fatigue was reported using multiple eligible outcome measurements (scales, time points). Fatigue was reported in a format that was not extractable for meta‐analysis. All outcomes that should be addressed (fatigue, cardiovascular disease, and death) were reported, but fatigue was not extractable.
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 had conflicts of interests. No other source of bias were apparent.