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
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{"title"=>"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", "type"=>"journal", "authors"=>[{"first_name"=>"Jie", "last_name"=>"Gong", "scopus_author_id"=>"56857063900"}, {"first_name"=>"Xinguang", "last_name"=>"Chen", "scopus_author_id"=>"8310272700"}, {"first_name"=>"Sijian", "last_name"=>"Li", "scopus_author_id"=>"36925610300"}], "year"=>2015, "source"=>"PLoS ONE", "identifiers"=>{"issn"=>"19326203", "isbn"=>"1932-6203", "pmid"=>"26426421", "scopus"=>"2-s2.0-84947283892", "doi"=>"10.1371/journal.pone.0139442", "sgr"=>"84947283892", "pui"=>"606879446"}, "id"=>"58f8798e-5b97-3a6d-9096-27ec6774246b", "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.", "link"=>"http://www.mendeley.com/research/efficacy-communitybased-physical-activity-program-km2h2-stroke-heart-attack-prevention-among-senior", "reader_count"=>86, "reader_count_by_academic_status"=>{"Unspecified"=>2, "Librarian"=>3, "Student > Doctoral Student"=>11, "Researcher"=>9, "Student > Ph. D. Student"=>14, "Student > Postgraduate"=>8, "Other"=>5, "Student > Master"=>10, "Student > Bachelor"=>15, "Lecturer"=>2, "Lecturer > Senior Lecturer"=>4, "Professor"=>3}, "reader_count_by_user_role"=>{"Unspecified"=>2, "Librarian"=>3, "Student > Doctoral Student"=>11, "Researcher"=>9, "Student > Ph. D. Student"=>14, "Student > Postgraduate"=>8, "Other"=>5, "Student > Master"=>10, "Student > Bachelor"=>15, "Lecturer"=>2, "Lecturer > Senior Lecturer"=>4, "Professor"=>3}, "reader_count_by_subject_area"=>{"Unspecified"=>4, "Agricultural and Biological Sciences"=>1, "Business, Management and Accounting"=>2, "Computer Science"=>2, "Decision Sciences"=>1, "Economics, Econometrics and Finance"=>1, "Engineering"=>1, "Nursing and Health Professions"=>20, "Medicine and Dentistry"=>31, "Neuroscience"=>4, "Sports and Recreations"=>2, "Psychology"=>3, "Social Sciences"=>13, "Immunology and Microbiology"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>31}, "Social Sciences"=>{"Social Sciences"=>13}, "Decision Sciences"=>{"Decision Sciences"=>1}, "Sports and Recreations"=>{"Sports and Recreations"=>2}, "Psychology"=>{"Psychology"=>3}, "Unspecified"=>{"Unspecified"=>4}, "Engineering"=>{"Engineering"=>1}, "Neuroscience"=>{"Neuroscience"=>4}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>1}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>1}, "Computer Science"=>{"Computer Science"=>2}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>2}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>20}}, "reader_count_by_country"=>{"United Kingdom"=>1, "Spain"=>1, "India"=>1}, "group_count"=>6}

Scopus | Further Information

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/2295340", "https://ndownloader.figshare.com/files/2295341"], "description"=>"<div><p>Objective</p><p>To evaluate the efficacy of the program <i>Keep Moving toward Healthy Heart and Healthy Brain</i> (KM2H<sup>2</sup>) in encouraging physical activities for the prevention of heart attack and stroke among hypertensive patients enrolled in the Community-Based Hypertension Control Program (CBHCP).</p><p>Design</p><p>Cluster randomized controlled trial with three waves of longitudinal assessments at baseline, 3 and 6 months post intervention.</p><p>Setting</p><p>Community-based and patient-centered self-care for behavioral intervention in urban settings of China.</p><p>Participants</p><p>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<sup>2</sup> plus standard CBHCP care (6 centers and 232 patients) or the standard care only (6 centers and 218 patients).</p><p>Intervention</p><p>KM2H<sup>2</sup> 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.</p><p>Outcome Measures</p><p>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.</p><p>Results</p><p>Relative to the standard care, receiving KM2H<sup>2</sup> 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- (<i>d</i> = 0.53, 95% CI: 0.21, 0.85) and 6-month (<i>d</i> = 0.45, 95% CI: 0.04, 0.85) post-intervention, respectively.</p><p>Conclusion</p><p>The program KM2H<sup>2</sup> 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<sup>2</sup> for use in community settings for prevention.</p><p>Trial Registration</p><p>ISRCTN Register <a href=\"http://www.controlled-trials.com/ISRCTN12608966\" target=\"_blank\">ISRCTN12608966</a></p></div>", "links"=>[], "tags"=>["isrctn", "Senior Hypertensive Patients", "dbp", "CBHCP", "KM 2H", "Social Capital Theory", "heart attack", "12 community health centers", "Heart Attack Prevention", "intervention", "stroke.Outcome MeasuresHeart attack", "ci", "respectively.ConclusionThe program KM 2H", "outcome"], "article_id"=>1561562, "categories"=>["Uncategorised"], "users"=>["Jie Gong", "Xinguang Chen", "Sijian Li"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0139442.s001", "https://dx.doi.org/10.1371/journal.pone.0139442.s002"], "stats"=>{"downloads"=>0, "page_views"=>15, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/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/1561562", "title"=>"Efficacy of a Community-Based Physical Activity Program KM2H<sup>2</sup> for Stroke and Heart Attack Prevention among Senior Hypertensive Patients: A Cluster Randomized Controlled Phase-II Trial", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2015-10-01 02:56:06"}
  • {"files"=>["https://ndownloader.figshare.com/files/2295335"], "description"=>"<p>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 (<i>p</i> = .331) and significant at 6 months post intervention (<i>p</i> = .028).</p>", "links"=>[], "tags"=>["isrctn", "Senior Hypertensive Patients", "dbp", "CBHCP", "KM 2H", "Social Capital Theory", "heart attack", "12 community health centers", "Heart Attack Prevention", "intervention", "stroke.Outcome MeasuresHeart attack", "ci", "respectively.ConclusionThe program KM 2H", "outcome"], "article_id"=>1561557, "categories"=>["Uncategorised"], "users"=>["Jie Gong", "Xinguang Chen", "Sijian Li"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0139442.g003", "stats"=>{"downloads"=>0, "page_views"=>11, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Differences_in_the_incidence_rate_of_heart_attack_between_the_KM2H_2_and_the_Standard_Care_Group_/1561557", "title"=>"Differences in the incidence rate (%) of heart attack between the KM2H<sup>2</sup> and the Standard Care Group.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2015-10-01 02:56:06"}
  • {"files"=>["https://ndownloader.figshare.com/files/2295334"], "description"=>"<p>Scheduling of Program Delivery for the KM2H<sup>2</sup>.</p>", "links"=>[], "tags"=>["isrctn", "Senior Hypertensive Patients", "dbp", "CBHCP", "KM 2H", "Social Capital Theory", "heart attack", "12 community health centers", "Heart Attack Prevention", "intervention", "stroke.Outcome MeasuresHeart attack", "ci", "respectively.ConclusionThe program KM 2H", "outcome"], "article_id"=>1561556, "categories"=>["Uncategorised"], "users"=>["Jie Gong", "Xinguang Chen", "Sijian Li"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0139442.g002", "stats"=>{"downloads"=>0, "page_views"=>11, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Scheduling_of_Program_Delivery_for_the_KM2H_2_/1561556", "title"=>"Scheduling of Program Delivery for the KM2H<sup>2</sup>.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2015-10-01 02:56:06"}
  • {"files"=>["https://ndownloader.figshare.com/files/2295339"], "description"=>"<p><b>Note</b>: The program effect on blood pressure reduction was estimated using a Mixed Effect model to adjust for the cluster randomization, baseline difference, repeated measurement, and covariates (i.e., age, income, marital status, years of HBP, adherence to medication, smoking and drinking). SD: Standard deviation; CI: Confidence interval; n/a: not applicable. Adjusted diff.: Adjusted differences.</p><p>Changes in blood pressure after receiving the intervention KM2H<sup>2</sup>, compared to the controls with standard care, results from the mixed effect modeling analysis, by gender.</p>", "links"=>[], "tags"=>["isrctn", "Senior Hypertensive Patients", "dbp", "CBHCP", "KM 2H", "Social Capital Theory", "heart attack", "12 community health centers", "Heart Attack Prevention", "intervention", "stroke.Outcome MeasuresHeart attack", "ci", "respectively.ConclusionThe program KM 2H", "outcome"], "article_id"=>1561561, "categories"=>["Uncategorised"], "users"=>["Jie Gong", "Xinguang Chen", "Sijian Li"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0139442.t003", "stats"=>{"downloads"=>0, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Changes_in_blood_pressure_after_receiving_the_intervention_KM2H_2_compared_to_the_controls_with_standard_care_results_from_the_mixed_effect_modeling_analysis_by_gender_/1561561", "title"=>"Changes in blood pressure after receiving the intervention KM2H<sup>2</sup>, compared to the controls with standard care, results from the mixed effect modeling analysis, by gender.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2015-10-01 02:56:06"}
  • {"files"=>["https://ndownloader.figshare.com/files/2295337"], "description"=>"<p>Comparison of the baseline characteristics of the study participants in the KM2H<sup>2</sup> (intervention) group and the Standard Care (control) group.</p>", "links"=>[], "tags"=>["isrctn", "Senior Hypertensive Patients", "dbp", "CBHCP", "KM 2H", "Social Capital Theory", "heart attack", "12 community health centers", "Heart Attack Prevention", "intervention", "stroke.Outcome MeasuresHeart attack", "ci", "respectively.ConclusionThe program KM 2H", "outcome"], "article_id"=>1561559, "categories"=>["Uncategorised"], "users"=>["Jie Gong", "Xinguang Chen", "Sijian Li"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0139442.t001", "stats"=>{"downloads"=>0, "page_views"=>13, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Comparison_of_the_baseline_characteristics_of_the_study_participants_in_the_KM2H_2_intervention_group_and_the_Standard_Care_control_group_/1561559", "title"=>"Comparison of the baseline characteristics of the study participants in the KM2H<sup>2</sup> (intervention) group and the Standard Care (control) group.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2015-10-01 02:56:06"}
  • {"files"=>["https://ndownloader.figshare.com/files/2295338"], "description"=>"<p><b>Note</b>: The program effect for each outcome variables was estimated using a Mixed Effect model to adjust for the cluster randomization, baseline difference, repeated measurement, and covariates. SD: Standard deviation; CI: Confidence interval; n/a: not applicable. Adjusted diff.: Adjusted differences,</p><p>*: <i>p</i> between 0.05–0.01,</p><p>**: <i>p</i> between 0.01–0.001, and</p><p>***: <i>p</i> < 0.001.</p><p>Program effect (differences and effect size) on tendency toward physically active and actual levels of physical activity between the KM2H<sup>2</sup> (intervention) and the Standard Care (control) group, overall and by gender.</p>", "links"=>[], "tags"=>["isrctn", "Senior Hypertensive Patients", "dbp", "CBHCP", "KM 2H", "Social Capital Theory", "heart attack", "12 community health centers", "Heart Attack Prevention", "intervention", "stroke.Outcome MeasuresHeart attack", "ci", "respectively.ConclusionThe program KM 2H", "outcome"], "article_id"=>1561560, "categories"=>["Uncategorised"], "users"=>["Jie Gong", "Xinguang Chen", "Sijian Li"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0139442.t002", "stats"=>{"downloads"=>0, "page_views"=>3, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Program_effect_differences_and_effect_size_on_tendency_toward_physically_active_and_actual_levels_of_physical_activity_between_the_KM2H_2_intervention_and_the_Standard_Care_control_group_overall_and_by_gender_/1561560", "title"=>"Program effect (differences and effect size) on tendency toward physically active and actual levels of physical activity between the KM2H<sup>2</sup> (intervention) and the Standard Care (control) group, overall and by gender.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2015-10-01 02:56:06"}
  • {"files"=>["https://ndownloader.figshare.com/files/2295336"], "description"=>"<p>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 (<i>p</i> = .230) and significant at 6 months post intervention (<i>p</i> = .015).</p>", "links"=>[], "tags"=>["isrctn", "Senior Hypertensive Patients", "dbp", "CBHCP", "KM 2H", "Social Capital Theory", "heart attack", "12 community health centers", "Heart Attack Prevention", "intervention", "stroke.Outcome MeasuresHeart attack", "ci", "respectively.ConclusionThe program KM 2H", "outcome"], "article_id"=>1561558, "categories"=>["Uncategorised"], "users"=>["Jie Gong", "Xinguang Chen", "Sijian Li"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0139442.g004", "stats"=>{"downloads"=>6, "page_views"=>11, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Differences_in_the_incidence_rate_of_stroke_between_the_KM2H_2_Group_and_the_Standard_Care_Group_/1561558", "title"=>"Differences in the incidence rate (%) of stroke between the KM2H<sup>2</sup> Group and the Standard Care Group.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2015-10-01 02:56:06"}
  • {"files"=>["https://ndownloader.figshare.com/files/2295333"], "description"=>"<p>Study Design (CONSORT Flow Diagram).</p>", "links"=>[], "tags"=>["isrctn", "Senior Hypertensive Patients", "dbp", "CBHCP", "KM 2H", "Social Capital Theory", "heart attack", "12 community health centers", "Heart Attack Prevention", "intervention", "stroke.Outcome MeasuresHeart attack", "ci", "respectively.ConclusionThe program KM 2H", "outcome"], "article_id"=>1561555, "categories"=>["Uncategorised"], "users"=>["Jie Gong", "Xinguang Chen", "Sijian Li"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0139442.g001", "stats"=>{"downloads"=>1, "page_views"=>6, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Study_Design_CONSORT_Flow_Diagram_/1561555", "title"=>"Study Design (CONSORT Flow Diagram).", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2015-10-01 02:56:06"}

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Relative Metric

{"start_date"=>"2015-01-01T00:00:00Z", "end_date"=>"2015-12-31T00:00:00Z", "subject_areas"=>[]}
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