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. 2019 Dec 2;2019(12):CD004542. doi: 10.1002/14651858.CD004542.pub3

Kouidi 2010.

Methods
  • Study design: parallel RCT

  • Time frame: not reported

  • Follow‐up period: 1 year

Participants
  • Country: Greece

  • Setting: single centre (Renal Unit of the AHEPA Hospital of Thessaloniki)

  • Inclusion criteria: no history of clinical signs or symptoms of psychiatric, neurological, cardiologic, or pulmonary disorders; absence of diabetes mellitus; no significant electrolytic instability or undisciplined patients; no musculoskeletal limitation or other medical problems contraindicating participation in an exercise training program

  • Number (analysed/randomised): treatment group (23/24); control group (15/20)

  • BDI score at baseline: treatment group (22.29 ± 6.71); control group (22.30 ± 6.81)

  • Mean age ± SD (years): treatment group (46.3 ± 11.2); control group (45.8 ± 10.9)

  • Sex (M/F): treatment group (14/10); control group (12/8)

  • Antidepressant medication: none of the patients was on antidepressants or other psychotropic agents

  • Exclusion criteria: not reported

Interventions Treatment group
  • 60 and 90 minutes of exercise during the first 2 hours of dialysis for 1 year


Control group
  • Sedentary control status


Co‐interventions
  • Not reported

Outcomes
  • Depression

    • BDI‐II: not depressed (0 to 9), mildly depressed (10 to 15), moderately depressed (16 to 23), severely depressed (≥ 24)

    • HADS

  • Anxiety

    • HADS

  • Cardiopulmonary exercise testing

    • VO2peak

    • Exercise time

  • Heart rate variability indices

    • SDNN (standard deviation of RR intervals)

    • MSSD (mean square successive differences)

    • pNN50 (percentage of RR intervals differing by more than 50 ms from the preceding RR)

    • LF/HF (low frequency power/high frequency power)

  • Clinical outcomes

    • Haemoglobin

    • Urea

    • Creatinine

    • Potassium

    • Sodium

    • Calcium

    • Phosphate

  • Adverse events

Notes
  • Funding source: not reported.

  • Trial registration identification number: not reported

  • Corresponding author: A.P. Deligiannis (stergios@med.auth.gr)

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Fifty participants met these criteria and were assigned to either an exercise training (group A) or to a sedentary control group (group B) through complete randomisation."
Comment: Sequence generation methods were not reported in sufficient detail to perform an adjudication
Allocation concealment (selection bias) Unclear risk Method of allocation concealment was not reported in sufficient detail to perform an adjudication
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Blinding of participants and/or the investigators was not reported. The methods of intervention and control treatment were physically different. Participants and investigators could be aware on the treatment allocation group
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "The Beck Depression Inventory (BDI‐II) is a self‐rating questionnaire for the assessment of the severity of depression. [...] The Hospital Anxiety and Depression Scale (HADS) is a self‐administered questionnaire for assessing depression and anxiety of general hospital patients."
Comment: The BDI‐II and the HADS were completed by participants. Participants were aware of the intervention they received. Therefore, the outcome assessment for depression and anxiety was not blinded
Incomplete outcome data (attrition bias) 
 All outcomes High risk Quote: "In 24 patients of group A (one dropped out of the exercise training program), a final similar exercise test was carried out after the completion of the last training session. Five patients of group B were lost to follow‐up."
Comment: 1/24 in the intervention group and 5/20 in the control group were lost to the follow‐up (> 10% loss to follow‐up; there was a differential loss between groups)
Selective reporting (reporting bias) Low risk There was no published protocol for this study. This study reported many patient‐centred outcomes that might be expected for a study of this type (i.e. depression; anxiety; adverse events)
Other bias Low risk No evidence of other sources of bias