HEART Camp Connect -Promoting Exercise in Adults With Heart Failure With Preserved Ejection Fraction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Nebraska
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
HEART Camp
BehavioralParticipants 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).
HEART Camp Connect
BehavioralParticipants 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).
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: HEART CampExperimental treatment 1 intervention
Group B: HEART Camp ConnectExperimental treatment 1 intervention
Group C: Enhanced Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Exercise Adherence
Adherence is measured as weekly minutes of moderate intensity exercise as measured by a watch and heart rate sensor.
Time frame
6 months2
Exercise Adherence
Adherence is measured as weekly minutes of moderate intensity exercise as measured by a watch and heart rate sensor.
Time frame
12 months3
Exercise Adherence
Adherence is measured as weekly minutes of moderate intensity exercise as measured by a watch and heart rate sensor.
Time frame
18 monthsSecondary outcomes
1
HF-related Health Status
Scores on the Kansas City Cardiomyopathy Questionnaire, assessing the domains of physical limitations, HF symptoms, quality of life, social impact of HF, and self efficacy. A 23-item questionnaire where scores are generated for each domain and scaled from 0-100, with 0 denoting the worst and 100 the best possible status.
Time frame
Baseline2
HF-related Health Status
Scores on the Kansas City Cardiomyopathy Questionnaire, assessing the domains of physical limitations, HF symptoms, quality of life, social impact of HF, and self efficacy. A 23-item questionnaire where scores are generated for each domain and scaled from 0-100, with 0 denoting the worst and 100 the best possible status.
Time frame
6 months3
HF-related Health Status
Scores on the Kansas City Cardiomyopathy Questionnaire, assessing the domains of physical limitations, HF symptoms, quality of life, social impact of HF, and self efficacy. A 23-item questionnaire where scores are generated for each domain and scaled from 0-100, with 0 denoting the worst and 100 the best possible status.
Time frame
12 months4
HF-related Health Status
Scores on the Kansas City Cardiomyopathy Questionnaire, assessing the domains of physical limitations, HF symptoms, quality of life, social impact of HF, and self efficacy. A 23-item questionnaire where scores are generated for each domain and scaled from 0-100, with 0 denoting the worst and 100 the best possible status.
Time frame
18 monthsOther outcomes
1
Self-Efficacy
Barriers Self-Efficacy Scale, assessing self-efficacy or confidence in exercising behavior. 13 items rated on a 100-point scale (each statement is scored on a 100-point percentage scale with 10-point increments.) Higher score values indicated greater perceived self-efficacy.
Time frame
Baseline2
Self-Efficacy
Barriers Self-Efficacy Scale, assessing self-efficacy or confidence in exercising behavior. 13 items rated on a 100-point scale (each statement is scored on a 100-point percentage scale with 10-point increments.) Higher score values indicated greater perceived self-efficacy.
Time frame
6 months3
Self-Efficacy
Barriers Self-Efficacy Scale, assessing self-efficacy or confidence in exercising behavior. 13 items rated on a 100-point scale (each statement is scored on a 100-point percentage scale with 10-point increments.) Higher score values indicated greater perceived self-efficacy.
Time frame
12 months4
Self-Efficacy
Barriers Self-Efficacy Scale, assessing self-efficacy or confidence in exercising behavior. 13 items rated on a 100-point scale (each statement is scored on a 100-point percentage scale with 10-point increments.) Higher score values indicated greater perceived self-efficacy.
Time frame
18 monthsSponsors and contacts
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Source ClinicalTrials.gov