Supportive Training After Cardiac Rehabilitation Including Virtual Engagement

Официальное название

Supportive Training After Cardiac Rehabilitation Including Virtual Engagement: The STRIVE Study

Обзор

The proposed research seeks to determine whether virtual coaching and social support focusing on key social cognitive factors will be an effective strategy for maintaining physical activity (PA) after completing cardiac rehabilitation (CR). Despite the well-documented benefits of CR, only 15-50% of individuals continue to exercise 6 months after completing CR.4-6 Thus, after 36 sessions (typically 12 weeks), many patients are left without the support necessary to sustain physical activity (PA) and prevent adverse secondary cardiac events. Though previous research has explored interventions to sustain PA after CR, many studies have been lacking in a theoretical basis, objective measurement of PA, measurement, and analysis of psychosocial and social cognitive factors, and long-term impact on clinical outcomes. Low-cost, pragmatic approaches to maintaining PA after CR is urgently needed for older adults, and virtual technologies offer promising solutions to promote adherence to PA. The three specific aims of the project are to: 1) determine the effect of virtual coaching and social support on adherence to PA (measured by objective step counts) in the intervention vs. control groups; secondary measures will be amount of sedentary time, functional fitness, and self-reported exercise; 2) determine the effect of virtual coaching and social support on psychosocial and social cognitive factors in the intervention vs. control groups; 2a) evaluate the extent to which psychosocial and social cognitive factors mediate the effect of the intervention on PA adherence; 3) examine differences in cardiovascular (CVD) risk factors (blood pressure, lipids, HbA1c, BMI) between groups.

Подробное описание

The investigators propose a randomized clinical trial in which the "STRIVE" control group will receive the Trainerize mobile app for (1) daily self monitoring of exercise, blood pressure, and weight; (2) education via weekly text messages; and (3) assigned monthly videos on various health topics. The "STRIVE +" intervention group will receive the same app for self-monitoring and education via text messages as the control group PLUS individually-tailored virtual coaching with goal-setting and social support/networking. Our specific aims are to:

Aim 1: Determine the effect of virtual coaching and social support on adherence to physical activity (PA; measured by objective step counts) in the intervention vs. control groups; secondary measures will be amount of sedentary time, functional fitness, and self-reported exercise.

Hypothesis 1: The intervention group will have more PA steps and self-reported exercise, less sedentary time, and higher functional fitness compared to the control group.

Aim 2: Determine the effect of virtual coaching and social support on psychosocial and social cognitive factors in the intervention vs. control groups.

Hypothesis 2: The intervention group will have lower depression/loneliness and higher self-efficacy/perceived social support compared to the control group.

Aim 2a: Evaluate the extent to which psychosocial and social cognitive factors mediate the effect of the intervention on PA adherence. Hypothesis 3: Lower depression/loneliness and higher perceived social support will mediate the effect of the intervention on PA adherence.

Aim 3: Examine differences in CVD risk factors (blood pressure, lipids, HbA1c, BMI) between groups. H: The intervention group will have better control of risk factors at 6, 12, and 18 months compared to control.

Вмешательства

• Поведенческое Virtual Coaching and social support
  The investigators propose a randomized clinical trial (RCT) of a virtual coaching and social support intervention that integrates evidence- and theory-based approaches to build self-efficacy, self-regulation, and perceived social support after cardiac rehabilitation (CR) to improve physical activity, psychosocial, social cognitive, and clinical outcomes, delivered via a social networking platform (Trainerize). Our intervention will also include goal setting for exercise and tailored feedback by

Первичные конечные точки

• Step counts [Срок оценки: At baseline, 3, and 6 months]

Вторичные конечные точки (12)

• Physical Activity, barriers and sedentary time: Rapid Assessment of Physical Activity scale [Срок оценки: Baseline, 3, 6, and 12 months]
• Physical Activity, barriers and sedentary time: Exercise Barriers Scale [Срок оценки: Baseline, 3, 6, and 12 months]
• Physical Activity, barriers and sedentary time: Self-reported sedentary time [Срок оценки: Baseline, 3, 6, and 12 months]
• Functional fitness tests: sit-to-stand [Срок оценки: Baseline, 3, 6, and 12 months]
• Functional fitness tests: 2 minute step test [Срок оценки: Baseline, 3, 6, and 12 months]
• Functional fitness tests: dumbbell curl test [Срок оценки: Baseline, 3, 6, and 12 months]
• Psychosocial factors: Depression [Срок оценки: Baseline, 3, 6, and 12 months]
• Psychosocial factors: Loneliness [Срок оценки: Baseline, 3, 6, and 12 months]
• Social cognitive factors: Self-efficacy [Срок оценки: Baseline, 3, 6, and 12 months]
• Social cognitive factors: Self-regulation [Срок оценки: Baseline, 3, 6, and 12 months]
• Social cognitive factors: Perceived social support [Срок оценки: Baseline, 3, 6, and 12 months]
• CV risk factors: hyperlipidemia [Срок оценки: Baseline, 3, 6, 12, and 18 months]

Критерии участия

Study population: We will recruit 286 older adults who are 55 years and older with qualifying diagnoses for cardiac rehabilitation (CR).

Критерии включения

• ≥ 55 years of age
• History of CVD that qualified patient for CR (myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, heart failure, valve replacement, etc.)
• Adherence (>50% of sessions for ≥1 month) to outpatient Phase II CR and pending completion

Критерии исключения

• Participation in Phase III CR (optional extended CR after outpatient Phase II CR for those who pay out-of-pocket)
• Cognitive impairment (per Mini-Cog assessment tool with score 0-2)
• Lack of English or Spanish proficiency/literacy
• Clinical conditions including:

• Unstable arrhythmias, aortic stenosis, thrombophlebitis, dissecting aneurysm or symptomatic anemia
• Active infection
• Uncontrolled hypertension: resting systolic >180 mmHg, diastolic >100 mmHg
• Decompensated heart failure, NYHA Class III-IV
• Current unstable angina
• 2nd or 3rd degree heart block or exercise induced arrhythmias

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of California, San Francisco — San Francisco

Публикации

• Leon AS, Franklin BA, Costa F, Balady GJ, Berra KA, Stewart KJ, Thompson PD, Williams MA, Lauer MS; American Heart Association; Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention); Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity); American association of Cardiovascular and Pulmonary Rehabilitation. Cardiac reh PMID 15668354
• Ades PA, Maloney A, Savage P, Carhart RL Jr. Determinants of physical functioning in coronary patients: response to cardiac rehabilitation. Arch Intern Med. 1999 Oct 25;159(19):2357-60. doi: 10.1001/archinte.159.19.2357. PMID 10547176
• Anderson L, Oldridge N, Thompson DR, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis. J Am Coll Cardiol. 2016 Jan 5;67(1):1-12. doi: 10.1016/j.jacc.2015.10.044. PMID 26764059
• Hellman EA. Use of the stages of change in exercise adherence model among older adults with a cardiac diagnosis. J Cardiopulm Rehabil. 1997 May-Jun;17(3):145-55. doi: 10.1097/00008483-199705000-00001. PMID 9187980
• Moore SM, Charvat JM, Gordon NH, Pashkow F, Ribisl P, Roberts BL, Rocco M. Effects of a CHANGE intervention to increase exercise maintenance following cardiac events. Ann Behav Med. 2006 Feb;31(1):53-62. doi: 10.1207/s15324796abm3101_9. PMID 16472039
• Elnaggar A, von Oppenfeld J, Whooley MA, Merek S, Park LG. Applying Mobile Technology to Sustain Physical Activity After Completion of Cardiac Rehabilitation: Acceptability Study. JMIR Hum Factors. 2021 Sep 2;8(3):e25356. doi: 10.2196/25356. PMID 34473064
• Stafford M, von Wagner C, Perman S, Taylor J, Kuh D, Sheringham J. Social connectedness and engagement in preventive health services: an analysis of data from a prospective cohort study. Lancet Public Health. 2018 Sep;3(9):e438-e446. doi: 10.1016/S2468-2667(18)30141-5. Epub 2018 Aug 22. PMID 30143472
• Holt-Lunstad J, Robles TF, Sbarra DA. Advancing social connection as a public health priority in the United States. Am Psychol. 2017 Sep;72(6):517-530. doi: 10.1037/amp0000103. PMID 28880099

Идентификаторы

NCT: NCT06701188 · 24-41119 · 1R01HL171287

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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