Research Priorities for Heart Failure With Preserved Ejection Fraction: National Heart, Lung, and Blood Institute Working Group Summary.
Sanjiv J Shah, Barry A Borlaug, Dalane W Kitzman...
https://pubmed.ncbi.nlm.nih.gov/32202936Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05784753
HEART Camp Connect: Supporting Exercise Adherence in Adults with Heart Failure with Preserved Ejection Fraction
Led by University of Nebraska · Updated on 2026-01-16
300
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults with heart failure with preserved ejection fraction (HFpEF) to understand how different exercise coaching methods affect their ability to exercise, improve symptoms, and change blood markers. The study compares three groups over 18 months: usual care with video exercises, in-person coaching with exercise, and virtual coaching via videoconference. The goal is to see which method helps patients stick to exercise routines and improves their health and physical function. Participants are randomly assigned to one of three groups: the usual care group accesses exercise videos online and does not meet with a coach; the HEART Camp group exercises and meets with a coach in person at a medical fitness center; and the HEART Camp Connect group exercises using videos and meets virtually with a coach. Coaching sessions occur weekly for the first 3 months and then every other week up to 12 months, with group exercise and Q&A sessions on alternate weeks. After 12 months, coaching ends, and participants manage their exercise independently for the final 6 months. Participants undergo an initial exercise test to ensure safety and receive training on using activity monitors, heart rate monitors, and exercise diaries. They wear activity monitors for 7 days at four study points (baseline, 6, 12, and 18 months), have blood drawn, complete a 6-minute walk test, and fill out questionnaires about heart failure and exercise. The study measures exercise adherence over time and tracks heart failure symptoms, physical function, inflammatory blood markers, and quality of life. The total participation lasts 18 months with regular monitoring and data collection.
CONDITIONS
Brief Title
HEART Camp Connect -Promoting Exercise in Adults With Heart Failure With Preserved Ejection Fraction
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Diagnosis of heart failure with an ejection fraction of 50% or higher
- Echocardiogram performed within the prior 24 months
- Stable medication therapy for at least 30 days before enrollment
- Evidence confirming HFpEF by specific scoring, invasive measures, or clinical diagnosis
You will not qualify if you...
- Life-limiting illness that prevents study completion
- Signs of worsening or decompensated heart failure
- Unstable angina or severe shortness of breath with minimal exertion
- Recent heart attack, bypass surgery, or pacemaker implantation within 6 weeks
- Orthopedic or neuromuscular conditions preventing aerobic exercise
- Abnormal exercise test results that make exercise unsafe
- Inability or unwillingness to complete pre-randomization procedures
- Pregnancy
- Having an implantable cardioverter defibrillator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for cardiopulmonary exercise testing (CPET) and safety evaluation
Run-in Period
Duration - Approximately 1 week
Participants complete 3 monitored cardiac rehabilitation sessions and study orientation including training on exercise platforms and monitoring devices.
3 monitored sessions and 1 in-person orientation visit
Treatment
Duration - 12 months
Participants engage in a 12-month exercise intervention with coaching. The HEART Camp group meets in-person; the HEART Camp Connect group meets virtually. Coaching frequency tapers over time with weekly sessions for 3 months and biweekly sessions with group training until month 12. The Enhanced Usual Care group receives virtual access and support without coaching.
Weekly 30-minute coaching sessions Months 1-3; every other week 15-minute coaching plus alternate week 1-hour group sessions Months 4-12
Follow-up
Duration - 6 months
Participants self-regulate exercise without coaching or motivational messages for 6 months after the intervention ends.
No scheduled coaching visits; participants continue exercise independently
Data Collection Visits
Duration - Throughout study duration
Participants meet with research staff at baseline, 6, 12, and 18 months for assessments including blood draws, 6-minute walk tests, activity monitoring, and surveys.
4 visits (in-person) at baseline, 6, 12, and 18 months
Trial Site Locations
Total: 3 locations
1
Henry Ford Health System
Detroit, Michigan, United States, 49201
Actively Recruiting
2
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-5330
Actively Recruiting
3
University of Virginia
Charlottesville, Virginia, United States, 22903
Not Yet Recruiting
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Research Team
W
Windy W Alonso, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Heart Disease and Stroke Statistics-2021 Update: A Report From the American Heart Association.
Salim S Virani, Alvaro Alonso, Hugo J Aparicio...
https://pubmed.ncbi.nlm.nih.gov/33501848ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC.
John J V McMurray, Stamatis Adamopoulos, Stefan D Anker...
https://pubmed.ncbi.nlm.nih.gov/22611136Exercise training as therapy for heart failure: current status and future directions.
Jerome L Fleg, Lawton S Cooper, Barry A Borlaug...
https://pubmed.ncbi.nlm.nih.gov/25605639Exercise training in patients with heart failure and preserved ejection fraction: meta-analysis of randomized control trials.
Ambarish Pandey, Akhil Parashar, Dharam Kumbhani...
https://pubmed.ncbi.nlm.nih.gov/25399909Study of adherence to exercise in heart failure: the HEART camp trial protocol.
Bunny J Pozehl, Kathleen Duncan, Melody Hertzog...
https://pubmed.ncbi.nlm.nih.gov/25433674Effects of the HEART Camp Trial on Adherence to Exercise in Patients With Heart Failure.
Bunny J Pozehl, Rita McGuire, Kathleen Duncan...
https://pubmed.ncbi.nlm.nih.gov/30010027Long-term exercise adherence in patients with heart failure: A qualitative study.
Shane Warehime, Danae Dinkel, Windy Alonso...
https://pubmed.ncbi.nlm.nih.gov/32861888Negative Attitudes, Self-efficacy, and Relapse Management Mediate Long-Term Adherence to Exercise in Patients With Heart Failure.
Windy W Alonso, Kevin Kupzyk, Joseph Norman...
https://pubmed.ncbi.nlm.nih.gov/33580663The influence of the HEART Camp intervention on physical function, health-related quality of life, depression, anxiety and fatigue in patients with heart failure.
Joseph F Norman, Kevin A Kupzyk, Nancy T Artinian...
https://pubmed.ncbi.nlm.nih.gov/31373222