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. 2021 Mar 30;2021(3):CD013119. doi: 10.1002/14651858.CD013119.pub2

Leehey 2009.

Study characteristics
Methods

  • Study design: parallel RCT

  • Recruitment: enrolment start and finish date not reported

  • Study duration: 24 weeks
Participants

  • Country: USA

  • Setting: Single centre, renal outpatient hospital clinic

  • Inclusion criteria: CKD stages 2 to 4; type 2 diabetes mellitus; BMI ≥ 30 kg/m²; proteinuria (urine PCR > 200 mg/g for ≥ 3 months); treatment with ACEi or ARB, aspirin, and statin (if low density lipoprotein > 100 mg/dL)

  • Number: Intervention group (7); control group (4)

  • Mean age (range): 66 years (55 to 81).

  • Sex (M/F): all males

  • Baseline characteristics

    • Nationality: not reported

    • Ethnicity: not reported

    • Mean baseline BMI (kg/m²): not reported

    • Stage of CKD: stages 2 to 4

    • Mean baseline eGFR ± SD (mL/min/1.73 m²): not reported

    • Mean baseline SBP ± SD (mmHg): intervention group (130 ± 28); control group (157 ± 14)

    • Mean baseline DBP ± SD (mmHg): intervention group (71 ± 20); control group (83 ± 20)

    • Mean baseline energy intake ± SD (kcal/day): intervention group (1878 ± 563); control group (1869 ± 13)

    • Comorbid conditions: type 2 diabetes mellitus (100%)

  • Exclusion criteria: hyperparathyroidism/osteoporosis; symptomatic neuropathy/retinopathy; positive stress test due to coronary arterial disease; symptomatic CVD; congestive heart failure (NYHA Class III or IV); chronic obstructive pulmonary disease (FEVI < 50% predicted and/or requires supplemental oxygen support during exercise); complaints of angina during the stress test; cerebrovascular disease/cognitive impairment; kidney transplant; inability to walk on the treadmill; any unforeseen illness or disability that would preclude exercise testing or training; participation in a formal exercise program within the previous 12 weeks
Interventions

  • Intervention type classification: lifestyle

  • Weight loss intervention/s used: aerobic exercise


Intervention group

  • Participants underwent thrice weekly exercise sessions for 6 weeks in a hospital research laboratory, followed by 18 weeks of home exercise sessions. Participants received instruction in walking and proper shoe selection. An introductory session was completed to educate participants on developing a walking program and to familiarize walking on a treadmill. Exercise programs were individualised and based on results of a baseline exercise test. Sessions included light warm up and stretching and began at 30 minutes and gradually increased by five minutes every two weeks. After 6 weeks of supervised walking program participants continued their program unsupervised in their home or local community and asked to increase their walk by 10% each week


Control group

  • Participants received standard medical care which included medical treatment for diabetes and chronic liver disease, including diabetes education. The control group and completed the same battery of testing but did not participate in any exercise training


Co‐interventions

  • Intensive medical management, diabetes teaching, and monitoring of food intake
Outcomes

  • Body weight (kg)

  • Body composition: lean mass (%) and fat mass (%)

  • CrCl (units)

  • SCr (mg/dL)

  • Proteinuria (mg/24 hours)

  • SBP (mmHg)

  • DBP (mmHg)

  • HbA1c (%)

  • Total cholesterol (mg/dL)

  • LDL cholesterol (mg/dL)

  • HDL cholesterol (mg/dL)

  • Triglycerides (mg/dL)

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

  • Dietary intake: energy intake (kcal/day)

  • Physical activity behaviours (exercise duration minutes)
Notes

  • Founding source: not reported

  • Additional data: requested see Appendix 3

  • Trial registration: not reported

  • Possible conflicts of interest for study author: nil declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Block randomisation used to allocate to treatment or control group
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 one of two intervention groups therefore study participants were unlikely to be blinded
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Insufficient information to permit judgement
Selective reporting (reporting bias) Low risk Authors report on what they intended to report on as described in the study aims
Other bias Unclear risk Insufficient information to permit judgement, no indication of adherence to intervention or whether the control group changed their exercise habits during the study