Limits...
Efficacy of a Community-Based Physical Activity Program KM2H2 for Stroke and Heart Attack Prevention among Senior Hypertensive Patients: A Cluster Randomized Controlled Phase-II Trial.

Gong J, Chen X, Li S - PLoS ONE (2015)

Bottom Line: 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.Relative to the standard care, receiving KM2H2 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 (-3.72 mmHg 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.The program KM2H2 is efficacious to reduce the risk of heart attack and stroke among senior patients who are on anti-hypertensive medication.

View Article: PubMed Central - PubMed

Affiliation: Department of Chronic Diseases, Wuhan Center for Disease Prevention and Control, Wuhan, China.

ABSTRACT

Objective: To evaluate the efficacy of the program Keep Moving toward Healthy Heart and Healthy Brain (KM2H2) 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 KM2H2 plus standard CBHCP care (6 centers and 232 patients) or the standard care only (6 centers and 218 patients).

Intervention: KM2H2 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 KM2H2 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 (-3.72 mmHg 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 KM2H2 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 KM2H2 for use in community settings for prevention.

Trial registration: ISRCTN Register ISRCTN12608966.

No MeSH data available.


Related in: MedlinePlus

Differences in the incidence rate (%) of heart attack between the KM2H2 and the Standard Care Group.Note: The generalized mixed effect model was used to compute the adjusted incidence rate. The random intercept and slope and the main effect of time and group were considered. Covariates of age, gender, marital status, income, year of hypertension, adherence to medication, use of alcohol and tobacco were adjusted. The intervention effect (interaction term in the model) was not significant at 3 months (p = .331) and significant at 6 months post intervention (p = .028).
© Copyright Policy
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4591119&req=5

pone.0139442.g003: Differences in the incidence rate (%) of heart attack between the KM2H2 and the Standard Care Group.Note: The generalized mixed effect model was used to compute the adjusted incidence rate. The random intercept and slope and the main effect of time and group were considered. Covariates of age, gender, marital status, income, year of hypertension, adherence to medication, use of alcohol and tobacco were adjusted. The intervention effect (interaction term in the model) was not significant at 3 months (p = .331) and significant at 6 months post intervention (p = .028).

Mentions: A total of 44 participants (14 from the intervention group and 30 from the control group) were diagnosed with heart attack and 61 with stroke (18 from the intervention group and 43 from the control group) during the 6-month follow-up period. After considering for the design effect of multi-center randomization with repeated measure, the main effect of time and group, the covariates of age, gender, tobacco smoking and alcohol consumption, and the adherence to anti-hypertensive medication, the adjusted incidence rates of stroke and heart attack for the two groups during the follow-up period are presented in Fig 3 and Fig 4. Relative to the standard care at the 6th month post-intervention, receiving KM2H2 was associated with significant reductions in the incidence (any events during follow-ups) of heart attack (3.60% vs. 7.03%, RR = 0.51, p < .05) with Cohen’s d = .37, 95% CI: [.34, .40], and stroke (5.11% vs. 9.90%, RR = 0.52, p < .05) with Cohen’s d = 0.36, 95% CI: [.32, .40].


Efficacy of a Community-Based Physical Activity Program KM2H2 for Stroke and Heart Attack Prevention among Senior Hypertensive Patients: A Cluster Randomized Controlled Phase-II Trial.

Gong J, Chen X, Li S - PLoS ONE (2015)

Differences in the incidence rate (%) of heart attack between the KM2H2 and the Standard Care Group.Note: The generalized mixed effect model was used to compute the adjusted incidence rate. The random intercept and slope and the main effect of time and group were considered. Covariates of age, gender, marital status, income, year of hypertension, adherence to medication, use of alcohol and tobacco were adjusted. The intervention effect (interaction term in the model) was not significant at 3 months (p = .331) and significant at 6 months post intervention (p = .028).
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4591119&req=5

pone.0139442.g003: Differences in the incidence rate (%) of heart attack between the KM2H2 and the Standard Care Group.Note: The generalized mixed effect model was used to compute the adjusted incidence rate. The random intercept and slope and the main effect of time and group were considered. Covariates of age, gender, marital status, income, year of hypertension, adherence to medication, use of alcohol and tobacco were adjusted. The intervention effect (interaction term in the model) was not significant at 3 months (p = .331) and significant at 6 months post intervention (p = .028).
Mentions: A total of 44 participants (14 from the intervention group and 30 from the control group) were diagnosed with heart attack and 61 with stroke (18 from the intervention group and 43 from the control group) during the 6-month follow-up period. After considering for the design effect of multi-center randomization with repeated measure, the main effect of time and group, the covariates of age, gender, tobacco smoking and alcohol consumption, and the adherence to anti-hypertensive medication, the adjusted incidence rates of stroke and heart attack for the two groups during the follow-up period are presented in Fig 3 and Fig 4. Relative to the standard care at the 6th month post-intervention, receiving KM2H2 was associated with significant reductions in the incidence (any events during follow-ups) of heart attack (3.60% vs. 7.03%, RR = 0.51, p < .05) with Cohen’s d = .37, 95% CI: [.34, .40], and stroke (5.11% vs. 9.90%, RR = 0.52, p < .05) with Cohen’s d = 0.36, 95% CI: [.32, .40].

Bottom Line: 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.Relative to the standard care, receiving KM2H2 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 (-3.72 mmHg 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.The program KM2H2 is efficacious to reduce the risk of heart attack and stroke among senior patients who are on anti-hypertensive medication.

View Article: PubMed Central - PubMed

Affiliation: Department of Chronic Diseases, Wuhan Center for Disease Prevention and Control, Wuhan, China.

ABSTRACT

Objective: To evaluate the efficacy of the program Keep Moving toward Healthy Heart and Healthy Brain (KM2H2) 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 KM2H2 plus standard CBHCP care (6 centers and 232 patients) or the standard care only (6 centers and 218 patients).

Intervention: KM2H2 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 KM2H2 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 (-3.72 mmHg 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 KM2H2 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 KM2H2 for use in community settings for prevention.

Trial registration: ISRCTN Register ISRCTN12608966.

No MeSH data available.


Related in: MedlinePlus