Skip to main content
. 2021 Mar 30;2021(3):CD013119. doi: 10.1002/14651858.CD013119.pub2

Baria 2014.

Study characteristics
Methods

  • Study design: prospective RCT

  • Study dates: enrolment start and finish date not reported

  • Study duration: 12 weeks
Participants

  • Country: Brazil

  • Setting: single centre; outpatient hospital CKD clinic

  • Inclusion criteria: BMI > 25 kg/m², aged 18 to 70 years, SBP < 180 mmHg, DBP < 100 mmHg, Hb > 11 g/dL, HbA1c < 8%

  • Number: centre‐based exercise group (10); home‐based exercise group (8); control group (9)

  • Mean age ± SD (years): centre‐based exercise group (52.1 ± 11.4); home‐based exercise group (50.8 ± 7.7); control group (53.4 ± 9.6)

  • Sex (M/F): all males

  • Baseline characteristics

    • Nationality: not reported

    • Ethnicity: not reported

    • Mean baseline BMI ± SD (kg/m²): centre‐based exercise group (30.8 ± 5.1); home‐based exercise group (30.9 ± 3.9); control group (29.6 ± 1.9)

    • Stage of CKD: 3 and 4

    • Mean baseline eGFR ± SD (mL/min/1.73 m²): centre‐based exercise group (25.8 ± 8.8); home‐based exercise group (29.4 ± 11.5); control group (27.7 ± 15.0)

    • Mean baseline SBP ± SD (mmHg): not measured

    • Mean baseline DBP ± SD (mmHg): not measured

    • Mean BP ± SD (mmHg): centre‐based exercise group (97.7 ± 7.4); home‐based exercise group (98.8 ± 13.2); control group (98.2 ± 11.6)

    • Mean baseline energy intake (kcal/kg/day): centre‐based exercise group (21.6 ± 6.9); home‐based exercise group (26.4 ± 7.3); control group (22.3 ± 6.1)

    • Comorbid conditions: 20% of study population had diabetes

  • Exclusion criteria: chronic obstructive pulmonary disease; congestive heart failure or active coronary disease; use of beta blockers or erythropoietin; positive cardiovascular stress test (positive criteria not defined)
Interventions

  • Intervention type classification: lifestyle

  • Weight loss intervention/s used: aerobic exercise


Home‐based exercise group

  • Aerobic exercise program: 3 walking sessions/week on alternate days, at a location at or nearby their home. Received guided support from exercise physiologist. Sessions began at 30 minutes and increased by 10 minutes every 4 weeks during a supervised training session. Intensity was prescribed according to ventilatory threshold obtained via cardiopulmonary exercise test at baseline


In‐centre based exercise group

  • Aerobic exercise program: 3 walking sessions/week on alternate days, walking on treadmill, in‐centre supervised by an exercise physiologist. Sessions began at 30 minutes and increased by 10 minutes every 4 weeks. Intensity was prescribed according to ventilatory threshold obtained via cardiopulmonary exercise test at baseline


Control group

  • Asked to not perform any physical exercise during the study intervention period


Co‐interventions

  • None reported
Outcomes

  • Body weight (kg)

  • BMI (kg/m²)

  • Waist circumference (cm)

  • Body composition: abdominal visceral fat (mm) and subcutaneous fat (mm), total fat mass (kg) lean body mass (kg)

  • Inflammation: C‐reactive protein (mg/dL)

  • Dietary intake: energy intake (kcal/kg/day)
Notes

  • Funding source: Foundation of Support the Research of the State of São Paulo (FAPESP no 2009/14786‐0), Support Foundation to the Federal University of São Paulo (FapUNIFESP) and Fundação Oswaldo Ramos

  • Additional data: start and finish dates requested (see Appendix 3)

  • Trial registration: number not reported

  • Possible conflicts of interest for study author: none declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes High risk Blinding of participants or study personnel was not described. Participants were randomised to a one of two exercise groups or control group. Therefore study participants were unlikely to be blinded
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk A blinded assessor was used to report abdominal computed tomography. It is not reported if assessors reporting on all other outcome measures were blinded, therefore there was insufficient information to permit judgement
Incomplete outcome data (attrition bias)
All outcomes Low risk Data available for 93% of study participants. Similar dropout rates in both treatment and control group
Selective reporting (reporting bias) Unclear risk Protocol not published; however authors appear to report on what they intended to report on as described in the study aims
Other bias Low risk Study appears free of other biases