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A walking intervention to increase weekly steps in dialysis patients: a pilot randomized controlled trial |
Sheshadri A, Kittiskulnam P, Lazar AA, Johansen KL |
American Journal of Kidney Diseases 2020 Apr;75(4):488-496 |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
RATIONALE AND OBJECTIVE: Patients receiving dialysis report very low physical activity. We implemented a pilot trial to assess the feasibility of a pedometer-based intervention to gather preliminary evidence about its impact on physical activity, symptoms, and surrogates of cardiovascular risk. STUDY DESIGN: Pilot randomized controlled trial. SETTING AND PARTICIPANTS: 60 dialysis patients from San Francisco dialysis clinics. INTERVENTION: Participants were randomly assigned 1:1 to receiving pedometers with weekly step goals or usual care for 3 months. OUTCOMES: The primary outcome was step counts, measured using pedometers. Secondary outcomes included physical performance using the Short Physical Performance Battery, the Physical Function and Vitality scales of the 36-Item Short Form Health Survey, the Dialysis Symptoms Index, and the Center for Epidemiologic Studies-Depression Scale, with endothelial function as a secondary and heart rate variability as an exploratory surrogate measure of cardiovascular risk. Targeted enrollment was 50% and targeted completion was 85%. RESULTS: 49% of approached patients were enrolled, and 92% completed the study. After 3 months, patients randomly assigned to the intervention (n = 30) increased their average daily steps by 2,256 (95% CI 978 to 3,537) more than the 30 controls (p < 0.001). Heart rate variability (standard deviation of N-N intervals) increased by 14.94 (95% CI 0.31 to 33.56) milliseconds in the intervention group as compared with controls (p = 0.05). There were no statistically significant differences across intervention groups in symptoms, physical performance, or endothelial function. Participants in the intervention group reverted to baseline steps during the postintervention follow-up. LIMITATIONS: The Northern California study setting may limit generalizability. Walking does not capture the full spectrum of physical activity. CONCLUSIONS: A short-term pedometer-based intervention led to increased step counts in dialysis patients, but the increase was not sustained. Pedometer-based interventions are feasible for dialysis patients, but future studies are needed to address whether more prolonged interventions can improve physical function or symptoms. FUNDING: Supported by grants from the American Kidney Fund, National Institutes of Health-National Institute of Diabetes and Digestive and Kidney Diseases, and International Society of Nephrology. TRIAL REGISTRATION: Registered at ClinicalTrials.gov with study identifier NCT02623348.
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