RecruitingNot ApplicableNCT05784753

HEART Camp Connect -Promoting Exercise in Adults With Heart Failure With Preserved Ejection Fraction

HEART (Heart Failure Exercise and Resistance Training) Camp Connect: Promoting Adherence to Exercise in Adults With Heart Failure With Preserved Ejection Fraction


Sponsor

University of Nebraska

Enrollment

300 participants

Start Date

Nov 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this study is to learn more about patients with heart failure with preserved ejection fraction (HFpEF) and exercise. Investigators want to see if meeting with a coach in person or by video conference will help these patients exercise, feel better, and change markers in their blood. Participants will be randomly placed in one of three groups for 18 months. All groups will have access to a fitness center and be given a watch and heart rate monitor to wear during exercise. The usual care group (control group) will have access to exercise videos via the medical fitness center and will not meet with a coach. The HEART Camp group will exercise and meet with their coach in-person at the medical fitness center. The HEART Camp Connect group will have access to exercise videos via the medical fitness center and will meet with their coach via videoconferencing. All participants will take part in an exercise test and study training prior to being randomized. At four data collection time points, participants will wear an activity monitor for 7 days each, have their blood drawn, and answer questions related to heart failure and exercise. Participants will also wear a heart rate monitor when they exercise and fill out a daily exercise diary.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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

Interventions

BEHAVIORALHEART Camp

Participants will meet with an in-person coach at the medical fitness center: Months 1-3 weekly for 30 minutes; Months 4-12 every other week for 15 minutes (on alternate weeks, participants will attend a 1-hour group-based exercise training and coaching).

BEHAVIORALHEART Camp Connect

Participants will meet with a virtual coach from the medical fitness center via videoconferencing: Months 1-3 weekly for 30 minutes; Months 4-12 every other week for 15 minutes (on alternate weeks, participants will attend a virtual 1-hour group-based exercise training and coaching session via videoconferencing).


Locations(3)

Henry Ford Health System

Detroit, Michigan, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

University of Virginia

Charlottesville, Virginia, United States

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NCT05784753


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