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Group-based exercise in CKD stage 3b to 4: a randomized clinical trial
Anand S, Ziolkowski SL, Bootwala A, Li J, Pham N, Cobb J, Lobelo F
Kidney Medicine 2021 Nov-Dec;3(6):951-961
clinical trial
5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; 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: We aimed to test interventions to improve physical activity in persons with advanced chronic kidney disease not yet receiving dialysis. STUDY DESIGN: Randomized controlled trial with parallel-group design. SETTING AND PARTICIPANTS: We embedded a pragmatic referral to exercise programming in high-volume kidney clinics servicing diverse populations in San Jose, CA, and Atlanta, GA. We recruited 56 participants with estimated glomerular filtration rates < 45 mL/min/1.73 m2. INTERVENTIONS: We randomly assigned participants to a mobile health (mHealth) group-wearable activity trackers and fitness professional counseling, or an exercise is medicine intervention framework (EIM) group-mHealth components plus twice-weekly small-group directed exercise sessions customized to persons with kidney disease. We performed assessments at baseline, 8 weeks at the end of active intervention, and 16 weeks after passive follow-up and used multilevel mixed models to assess between-group differences. OUTCOMES: Activity tracker total daily step count. RESULTS: Of 56 participants, 86% belonged to a racial/ethnic minority group; randomly assigned groups were well balanced on baseline step count. In intention-to-treat analyses, the EIM and mHealth groups both experienced declines in daily step counts, but there was an attenuated reduction in light intensity physical activity (standard error 0.2 (5.8) versus -8.5 (5.4) min/d; p = 0.08) in the EIM compared with the mHealth group at 8 weeks. In as-treated analyses, total daily step count, distance covered, and light and moderate-vigorous activity minutes per day improved in the EIM group and declined in the mHealth group at 8 weeks (standard error +335 (506) versus -884 (340) steps per day; p = 0.05; p < 0.05 for secondary measures), but group differences faded at 16 weeks. There were no differences in quality-of-life and mental health measures during the study. Limitations: Small sample size, limited duration of study, assessment of intermediate outcomes (steps per day). CONCLUSIONS: A clinic-integrated referral to small-group exercise sessions is feasible, safe, and moderately effective in improving physical activity in an underserved population with high comorbid conditions. FUNDING: Normon S Coplon Applied Pragmatic Clinical Research program. TRIAL REGISTRATION: NCT03311763.

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