A theory-driven exercise intervention among community-dwelling (pre)frail older adults: Protocol for a stepped-wedge cluster-randomized trial.

Aim: This study is aimed to evaluate the effectiveness of a theory-driven exercise intervention for Chinese community-dwelling (pre)frail older adults, and to clarify the underlying mechanisms of the exercise intervention in this population.

Design: A stepped-wedge cluster-randomized trial.

Methods: A stepped-wedge cluster-randomized trial will be conducted among (pre)frail older adults at six communities in a county of central China. A 12-week multicomponent exercise intervention based on the integration of the Health Belief Model (HBM) and the Theory of Planned Behaviour (TPB) will be implemented to all participants during the study period. The primary outcomes are frailty, muscle mass, muscle strength and physical performance. Secondary outcomes include beliefs in exercise, exercise behaviours and other physical, mental and social functioning. Assessments will be conducted at baseline and at week 12, 24 and 36. A multilevel regression model will be used to evaluate the effectiveness of exercise interventions. A multilevel mediation model will be used to clarify the underlying mechanisms of this exercise intervention.

Discussion: This study is expected to provide an effective and practical mode for exercise interventions among Chinese community-dwelling (pre)frail older adults, and contribute to the existing evidence in this field.

Trial Registration: Chinese Clinical Trial Registry ChiCTR2100041981.