Group-Based Exercise in CKD Stage 3b to 4: A Randomized Clinical Trial

Shuchi Anand, Susan L Ziolkowski, Ahad Bootwala, Jianheng Li, Nhat Pham, Jason Cobb, Felipe Lobelo, Shuchi Anand, Susan L Ziolkowski, Ahad Bootwala, Jianheng Li, Nhat Pham, Jason Cobb, Felipe Lobelo

Abstract

Rationale & 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 & 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] vs -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] vs -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.

Keywords: Chronic kidney disease; exercise physical activity; mobile health; underserved populations.

© 2021 Published by Elsevier Inc. on behalf of the National Kidney Foundation, Inc.

Figures

Graphical abstract
Graphical abstract
Figure 1
Figure 1
Study participant enrollment flowchart. Abbreviations: eGFR, estimated glomerular filtration rate; EIM, Exercise Is Medicine; mHealth, mobile health.
Figure 2
Figure 2
Overall physical activity assessment over time in the intervention.∗ (A) Adjusted means for step counts per day over time in intention-to-treat analyses (N = 28 for Exercise Is Medicine [EIM] and N = 28 for mobile health [mHealth]). Differences in EIM versus mHealth as follows: −217.6 (standard errors [SE] 610.4) versus −730.9 (SE 568.1) steps comparing 8 weeks with baseline, P = 0.25, and −1,217.1 (SE 624.4) versus −946.1 [SE 576.9] steps, P = 0.84, comparing 16 weeks to baseline. (B) Adjusted means for distance (meters) per day over time in intention-to-treat analyses. Differences in EIM versus mHealth as follows: −126.0 (SE 490.5) versus −492.6 (SE 457.8) m comparing 8 weeks with baseline, P = 0.22, and −1,286.9 (SE 502.2) versus −635.7 (SE 464.7) m, P = 0.48 comparing 16 weeks with baseline. (C) Adjusted means for step counts per day over time in as-treated analyses (N = 16 for EIM and N = 30 for mHealth). Differences in EIM versus mHealth as follows: +334.6 (SE 506.0) versus −883.8 (SE 339.6) steps, P = 0.05 comparing 8 weeks with baseline, and +381.8 (SE 923.7) versus −1,362.9 (SE 644.3) steps, P = 0.39, comparing 16 weeks with baseline. (D) Adjusted means for distance (meters) per day over time in in as-treated analyses. Differences in EIM versus mHealth as follows: +374.5 (SE 358.6) versus −619.6 (SE 240.7) m, P = 0.03, comparing 8 weeks with baseline, and −865.5 (SE 734.4) versus 957.8 (SE 513.3) m, P = 0.92, comparing 16 weeks with baseline. ∗In the intention-to-treat analysis, sample sizes were 20, 24, and 21 in the EIM group and 23, 24, and 23 in the mHealth group at the baseline, 8-week, and 16-week assessments. In the as-treated analysis, sample sizes were 13, 16, and 16 in the EIM group and 30, 32, and 28 in the mHealth group at the baseline, 8-week, and 16-week assessments, respectively.
Figure 3
Figure 3
Intensity of physical activity assessment over time in the intervention.∗ (A) Minutes of light physical activity (PA) per day over time in intention-to-treat analyses (N = 28 for Exercise Is Medicine [EIM] and N = 28 for mobile health [mHealth]). Differences in EIM versus mHealth as follows: −0.2 (standard errors [SE] 5.8) versus −8.5 (SE 5.4) minutes per day comparing 8 weeks with baseline, P = 0.08, and −6.3 (SE 6.0) versus −9.7 (SE 5.5) minutes per day, P = 0.69, comparing 16 weeks with baseline. (B) Minutes of moderate to vigorous PA (MVPA) per day over time in intention-to-treat analyses. Differences in EIM versus mHealth as follows: 1.1 (SE 1.6) versus −2.3 (SE 1.5) minutes per day comparing 8 weeks with baseline, P = 0.02, and 2.7 (SE 1.7) versus -2.2 (SE 1.6) minutes per day, P = 0.08 comparing 16 weeks with baseline. (C) Minutes of light PA per day over time in as-treated analyses (N = 16 for EIM and N = 30 for mHealth). Differences in EIM versus mHealth as follows: 4.5 (SE 7.0) versus −8.8 (SE 4.7) minutes per day, P = 0.02, comparing 8 weeks with baseline, and 1.6 (SE 7.0) versus −13.0 (SE 4.9) minutes per day, P = 0.20, comparing 16 weeks with baseline. (D) Minutes of MVPA per day over time in as-treated analyses. Differences in EIM versus mHealth: 1.7 (SE 2.0) versus −1.8 (SE 1.4) minutes per day comparing 8 weeks with baseline, P = 0.04, and 3.6 (SE 2.0) versus −1.8 (SE 1.4) minutes per day, P = 0.06, comparing 16 weeks with baseline. ∗In the intention-to-treat analysis, sample sizes were 20, 24, and 21 in the EIM group and 23, 24, and 23 in the mHealth group at the baseline, 8-week, and 16-week assessments, respectively. In the as-treated analysis, sample sizes were 13, 16, and 16 in the EIM group and 30, 32, and 28 in the mHealth group at the baseline, 8-week, and 16-week assessments, respectively.

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