Efficacy of a Community-Based Physical Activity Program KM2H(2) for Stroke and Heart Attack Prevention among Senior Hypertensive Patients: A Cluster Randomized Controlled Phase-II Trial

OBJECTIVE: To evaluate the efficacy of the program Keep Moving toward Healthy Heart and Healthy Brain (KM2H(2)) in encouraging physical activities for the prevention of heart attack and stroke among hypertensive patients enrolled in the Community-Based Hypertension Control Program (CBHCP). DESIGN: Cluster randomized controlled trial with three waves of longitudinal assessments at baseline, 3 and 6 months post intervention. SETTING: Community-based and patient-centered self-care for behavioral intervention in urban settings of China. PARTICIPANTS: A total of 450 participants diagnosed with hypertension from 12 community health centers in Wuhan, China were recruited, and were randomly assigned by center to receive either KM2H(2) plus standard CBHCP care (6 centers and 232 patients) or the standard care only (6 centers and 218 patients). INTERVENTION: KM2H(2) is a behavioral intervention guided by the Transtheoretical Model, the Model of Personalized Medicine and Social Capital Theory. It consists of six intervention sessions and two booster sessions engineered in a progressive manner. The purpose is to motivate and maintain physical activities for the prevention of heart attack and stroke. OUTCOME MEASURES: Heart attack and stroke (clinically diagnosed, primary outcome), blood pressure (measured, secondary outcome), and physical activity (self-report, tertiary outcome) were assessed at the individual level during the baseline, 3- and 6-month post-intervention. RESULTS: Relative to the standard care, receiving KM2H(2) was associated with significant reductions in the incidence of heart attack (3.60% vs. 7.03%, p < .05) and stroke (5.11% vs. 9.90%, p<0.05), and moderate reduction in blood pressure (-3.72mmHg in DBP and -2.92 mmHg in DBP) at 6-month post-intervention; and significant increases in physical activity at 3- (d = 0.53, 95% CI: 0.21, 0.85) and 6-month (d = 0.45, 95% CI: 0.04, 0.85) post-intervention, respectively. CONCLUSION: The program KM2H(2) is efficacious to reduce the risk of heart attack and stroke among senior patients who are on anti-hypertensive medication. Findings of this study provide solid data supporting a formal phase-III trial to establish the effectiveness of KM2H(2) for use in community settings for prevention. TRIAL REGISTRATION: ISRCTN Register ISRCTN12608966