HEART Camp Connect: A Feasibility Study

Not Applicable

Terminated

Conditions: Heart Failure With Preserved Ejection Fraction

Interventions: Behavioral: HEART Camp Connect

Registration Number: NCT05985395

Lead Sponsor: University of Nebraska

Brief Summary: This study builds on the tested and refined HEART Camp intervention which has been shown to improve long-term adherence to exercise in individuals diagnosed with heart failure. HEART Camp Connect enhances HEART Camp by delivering the coaching via videoconference and providing access to hospital-based exercise facilities and online exercise programming. This prospective study uses a 2-group, randomized repeated measures experimental design with 3 data collection points baseline, Month 3, and Month 6.

Detailed Description: Potential participants will be approached at a Heart Failure clinic at an academic medical center. As a secondary recruitment strategy, we will use a database that identifies patients who previously indicated their willingness to be contacted for clinical research.

Study personnel will obtain informed consent in person in a private room or over the phone facilitated by the academic medical center electronic consent process. Once consented, participants will complete cardiopulmonary exercise testing (CPET) to guide individual exercise prescriptions and protect against risks associated with exercise. CPET results that preclude safe exercise training (arrhythmia) or those with CPET results indicating cardio-respiratory fitness (females with maximum oxygen consumption ≥ 21ml/kg/min and males with oxygen consumption ≥ 24 ml/kg/min) will be withdrawn from the study.

Participants will be given instruction on the use of the heart rate monitor. Participants will wear their monitor exercise sessions for heart rate monitoring. Participants will also receive educational training via videos on topics such as exercising with heart failure, how medications impact exercise, and nutrition.

Participants will be instructed to wear a heart rate monitor and strive to meet a goal of 150 minutes of moderate-intensity exercise per week. Minutes toward adherence goals for the study will be calculated as time spent participating in a moderate-intensity activity and determined by their CPET results and personalized exercise prescription.

Each participant will be given access to an Omaha-based exercise coach that he/she will meet with weekly over Zoom for 30 minutes. Coaches will discuss exercise over the past week including problems, issues, concerns. Goals will be set, reviewed, assessed, and revised each week. For virtual exercise, all participants will access a Virtual Wellness Center.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 11

Inclusion Criteria

Diagnosis of heart failure (HF) with an ejection fraction (EF) ≥50%
Age ≥18 years
English-speaking
Echocardiogram in prior 12 months
Stable pharmacologic therapy in past 30 days

Exclusion Criteria

Score<6 on a diagnostic algorithm
Life-limiting illness precluding study completion
Clinical evidence of decompensated HF
Unstable angina or marked shortness of breath on exertion at <2 metabolic equivalents
Myocardial infarction, coronary artery bypass surgery, or biventricular pacemaker <6 weeks
Orthopedic or neuromuscular disorders preventing participation in aerobic exercise
Cardiopulmonary exercise test results that preclude safe exercise
Unwilling/unable to complete pre-randomization procedures
Pregnancy
Implantable cardioverter-defibrillator

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HEART Camp Connect	HEART Camp Connect	Participants will have access to a virtual exercise platform or membership to a medical exercise facility. Participants will meet with a virtual exercise coach via Zoom on a weekly basis.

Primary Outcome Measures

Name	Time	Method
Exercise Adherence	3 months	Exercise adherence is defined as a count of the number of participants meeting 120 minutes or more of moderate intensity exercise per week at the prespecified time point of 3 months.

Secondary Outcome Measures

Name	Time	Method
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score	3 months	KCCQ measures heart failure related health status. The overall summary score ranges from 0 to 100, with higher scores indicating better health status, typically interpreted in 25-point ranges as: very poor to poor (0-24), poor to fair (25-49), fair to good (50-74), and good to excellent (75-100). A change in score of 5 points or more is considered clinically meaningful.