Effectiveness of a BCW theory-based exercise adherence intervention protocol in Chinese maintenance hemodialysis patients: a randomized controlled trial

Abstract

Objective: To develop and implement a theory-based exercise adherence intervention grounded in the behavior change wheel (BCW) framework, with the goal of improving exercise adherence among maintenance hemodialysis (MHD) patients, enhancing clinical outcomes, and maximizing the benefits of physical activity. Methods: This study included two phases. In Phase I (Development), we used the BCW framework to develop the intervention. This process involved semi-structured patient interviews and evidence synthesis, followed by refinement with an expert panel. In Phase II (Evaluation), we performed an assessor-blinded randomized controlled trial (RCT). We randomly assigned 80 MHD patients (1:1) to either the intervention or control group. A computer-generated sequence determined allocation, which was concealed with opaque, sealed envelopes. The intervention group received the BCW-based exercise protocol via mobile health (mHealth) technology, and the control group received standard nursing care. Throughout the trial, outcome assessors and data analysts remained blinded to group assignment. Results: Following the 12-week intervention, the intervention group demonstrated significantly greater exercise adherence scores compared to controls (p < 0.001). Key outcome measures demonstrated statistically significant improvements in the intervention group, including: increased average daily step count (p < 0.001), enhanced grip strength (p = 0.004), improved 6-meter walking speed (p < 0.001), greater 6-min walk distance (p < 0.001), higher skeletal muscle mass index (p = 0.019), improved dialysis adequacy (Kt/V, p = 0.034), and elevated serum albumin levels (p = 0.009). The intervention group also showed significantly lower triglyceride-glucose (TyG) index values (p = 0.004). No significant changes were observed in inflammatory markers (p > 0.05). Conclusion: The study findings demonstrate the efficacy of a BCW-based exercise adherence intervention program in enhancing exercise adherence, physical functioning, dialysis adequacy, nutritional status, and glucose-lipid metabolism among MHD patients. Clinical trial registration: https://www.chictr.org.cn; identifier (ChiCTR2400091015).