An interventional study of HEART Camp Connect in Heart Failure With Preserved Ejection Fraction, sponsored by University of Nebraska. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by University of Nebraska · Not applicable, Interventional, and Health services research
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.
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(females with maximum oxygen consumption ≥ 21ml/kg/min and males with oxygen consumption ≥ 24 ml/kg/min) will be withdrawn from the study.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.
University of Nebraska is the lead sponsor of 473 studies on the registry; 66 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: HEART Camp Connect
Participants will have access to a virtual exercise platform or membership to a medical exercise facility.
Once eligible and enrolled, participants will complete 150 minutes of moderate-intensity exercise a week with help of a virtual exercise coach.
Exercise Adherence
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.
Time frame: 3 months
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
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.
Time frame: 3 months
Smart Devices
Measures is a count of the number of potential participants without smart devices at baseline. Participants without a smart device are loaned one for the duration of the study.
Time frame: Baseline
| Milestone | HEART Camp Connect | Usual Care |
|---|---|---|
| Started | 7 | 4 |
| Completed | 4 | 3 |
| Not completed | 3 | 1 |
| Withdrew: Physician decision | 2 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| Participants | HEART Camp Connect | Usual Care |
|---|---|---|
| Exercise Adherence | 1 | 1 |
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.
| units on a scale | HEART Camp Connect | Usual Care |
|---|---|---|
| Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | 56.7 ± 14.3 | 57.4 ± 16.1 |
Measures is a count of the number of potential participants without smart devices at baseline. Participants without a smart device are loaned one for the duration of the study.
| Participants | HEART Camp Connect | Usual Care |
|---|---|---|
| Smart Devices | 2 | 1 |
Collected over Events data collected for 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HEART Camp Connect | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Usual Care | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Age, Continuous(years) | HEART Camp Connect | Usual Care | Total |
|---|---|---|---|
| Mean | 69.5 ± 14.01 | 70.3 ± 6.4 | 69.9 ± 10.6 |
| Sex: Female, Male(Participants) | HEART Camp Connect | Usual Care | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | HEART Camp Connect | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 4 | 2 | 6 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | HEART Camp Connect | Usual Care | Total |
|---|---|---|---|
| United States | 4 | 3 | 7 |
| Exercise Adherence(Participants) | HEART Camp Connect | Usual Care | Total |
|---|---|---|---|
| Count of participants | 0 | 0 | 0 |
| Kansas City Cardiomyopathy Questionnaire Overall Summary Score(units on a scale) | HEART Camp Connect | Usual Care | Total |
|---|---|---|---|
| Mean | 46.3 ± 16.3 | 48.7 ± 17.1 | 47.7 ± 15.4 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Nebraska