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HEART Camp Connect -Promoting Exercise in Adults With Heart Failure With Preserved Ejection Fraction
NCT05784753 · University of Nebraska
In plain English
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Official title
HEART (Heart Failure Exercise and Resistance Training) Camp Connect: Promoting Adherence to Exercise in Adults With Heart Failure With Preserved Ejection Fraction
About this study
The overall objectives for this study are to: (a) test the efficacy of virtual and in-person exercise interventions to promote long-term adherence to exercise; (b) determine a benchmark of exercise minutes that reaches a minimal clinically important difference in heart failure related health status and drives improvements in physical function, inflammatory markers, and patient-reported outcomes; (c) identify interventional mechanisms, interim clinical events and prognostic indicators of heart failure with preserved ejection fraction (HFpEF) that mediate adherence; (d) assess delivery method and related cost of the intervention to support translation and scalability. To meet these objectives, investigators propose a three-group, 2-2-1 randomized repeated measures experimental design with 4 data collection points \[baseline, 6, 12, and 18 months to compare HEART Camp, HEART Camp Connect, and virtual enhanced usual care (EUC).
This study begins with the cardiopulmonary exercise testing (CPET) . The CPET is used to develop an exercise prescription and ensure participant safety and readiness for exercise. Participants who have completed a CPET within 6 months of enrollment with no changes in medications will not repeat the test. Any participants who exhibit potential safety concerns during CPET (e.g. cardiac arrhythmias, balance instability) will be evaluated by a trained providers, prior to continuing in the study. Those deemed unsafe to exercise will be withdrawn. After the CPET, participants will take part in the run-in period with 3 monitored sessions in cardiac rehabilitation and study orientation. All participants will be oriented during a one-time in-person training to familiarize them with the 1) Either in-person Engage center or Engage virtual platform via the HEART Camp You Tube channel; 2) All monitoring devices (Polar watch and Polar heart rate monitor, Actigraph, rating of perceived exertion scale, and exercise diary); and 3) Private HEART Camp You Tube channel where they can view investigator-developed educational videos specific to HFpEF and virtual exercise content. Participants who do not have a smart device with internet capability or have an insufficient data plan will be given a tablet with a wireless data plan for study use.
After randomization, participants in the intervention groups (HEART Camp Connect and HEART Camp) meet with a coach for the first 12 months of the study. The HEART Camp group will meet in-person at the medical fitness center with their coach. The HEART Camp Connect group will meet virtually, over videoconference. To improve the scalability of this intervention, investigators will taper coaching sessions according to the following schedule: Months 1-3 weekly, 1-on-1 coaching for 30 minutes; Months 4-12 1-on-1 coaching is reduced to 15 minute sessions every other week. On alternate weeks, participants will attend a 1-hour group-based exercise training and coaching. During these sessions, the coach will meet with 4-6 participants at once. One half of the class will be an exercise training session and the other half will be a question/answer session for participants to talk to the coach and each other about strategies for exercise. After 12 months, coaching (both intervention groups) and motivational messages (HEART Camp Connect only) will stop and participants will be expected to self-regulate exercise in months 13-18.
Participants will be asked to build up to 150 minutes of moderate-intensity exercise weekly. During exercise sessions, participants will be asked to wear their study-provided watch and heart rate monitor and keep a daily exercise diary.
Participants will meet with research personnel at 4 times during the study for data collection including where they will have their blood drawn and complete a 6 minute walk test. At these data collection time points, participants will also wear an activity monitor for 7 days/nights and complete surveys related to their heart failure and exercise.
Eligibility criteria
Inclusion Criteria:
* Diagnosis of heart failure with an ejection fraction greater than or equal to 50
* Echocardiogram in prior 24 months
* Stable pharmacologic therapy in the past 30 days
* Any of the following evidence to confirm HFpEF - Score\< 6 on Heavy Hypertensive Atrial Fibrillation, Pulmonary Hypertension, Elder, Filling Pressure algorithm, invasive hemodynamic evidence of HFpEF(i.e., elevated pulmonary wedge pressure), or a confirmed clinical diagnosis of HFpEF
Exclusion Criteria:
* Life-limiting illness precluding study completion
* Clinical evidence of decompensated heart failure
* Unstable angina or marked shortness of breath on exertion at less than 2 metabolic equivalents
* Myocardial infarction, coronary artery bypass graft, or biventricular pacemaker in prior 6 weeks
* Orthopedic or neuromuscular disorders preventing aerobic exercise
* Cardiopulmonary exercise test results that preclude safe exercise
* Unwilling/unable to complete pre-randomization procedures
* Pregnancy
* Implantable cardioverter defibrillator
Study design
Enrollment target: 300 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2023-11-20
Estimated completion: 2028-03
Last updated: 2026-01-16
Interventions
Behavioral: HEART CampBehavioral: HEART Camp Connect
Primary outcomes
- • Exercise Adherence (6 months)
- • Exercise Adherence (12 months)
- • Exercise Adherence (18 months)
Sponsor
University of Nebraska · other
Contacts & investigators
ContactWindy W Alonso, PhD · contact · windy.alonso@unmc.edu · 402-559-8342
InvestigatorWindy W Alonso, PhD · principal_investigator, University of Virginia
InvestigatorBunny Pozehl, PhD · principal_investigator, University of Nebraska
All locations (3)
Henry Ford Health SystemRecruiting
Detroit, Michigan, United States
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
University of VirginiaNot Yet Recruiting
Charlottesville, Virginia, United States