Exercise Coaching for Heart Failure

Recruiting at 2 trial locations

Overseen By Windy W Alonso, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Disqualifiers: Life-limiting illness, Decompensated heart failure, Unstable angina, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if meeting with a coach can help individuals with heart failure with preserved ejection fraction (a type of heart condition) exercise more and feel better. Participants will be divided into three groups: one will meet coaches in person, another will meet them by video, and a third group will not meet with a coach but will have access to exercise videos. All participants will wear devices to track their activity and heart rate, and provide blood samples and feedback about their exercise and heart health. This trial seeks individuals who have had heart failure with preserved ejection fraction confirmed by a doctor and have been on stable medication for the past month. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve exercise strategies for heart failure patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have stable medication therapy for the past 30 days, which suggests you may continue your current medications if they are stable.

What prior data suggests that this exercise coaching protocol is safe for heart failure patients?

Research shows that exercise is generally safe for people with heart failure with preserved ejection fraction (HFpEF). Studies have found that supervised exercise can enhance physical abilities, quality of life, and mood in these patients. Although specific information on the safety of independent exercise for HFpEF is lacking, exercise training overall has proven effective.

In the HEART Camp program, research found that a varied exercise plan helps participants maintain their routine and improve both physical health and perceptions of health. The HEART Camp Connect program, which includes virtual coaching, demonstrated similar benefits in promoting regular exercise.

In summary, despite the absence of detailed safety data for these specific programs, existing research indicates that exercise training for HFpEF is generally safe and beneficial. Participants in these programs are likely to experience positive health effects without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HEART Camp and HEART Camp Connect because they offer a fresh approach to managing heart failure through personalized exercise coaching. Unlike traditional heart failure treatments that primarily rely on medication and lifestyle changes, these programs emphasize direct, personalized coaching, either in-person or virtually. HEART Camp provides face-to-face interaction with a coach at a medical fitness center, while HEART Camp Connect offers the convenience of virtual coaching and motivational messaging to boost adherence. This focus on tailored exercise plans and accessibility aims to empower patients more effectively than current options.

What evidence suggests that this trial's exercise coaching interventions could be effective for heart failure?

Research has shown that exercise is one of the few treatments that can help people with heart failure with preserved ejection fraction (HFpEF). In this trial, participants may join the HEART Camp program, which has significantly improved physical ability, quality of life, and reduced feelings of depression. Studies found that those in the HEART Camp group adhered to their exercise routines better than those receiving standard care. Alternatively, participants may join the HEART Camp Connect program, where regular exercise improved health outcomes, and virtual coaching greatly increased adherence to exercise over time. Both programs in this trial aim to make exercising more effective and enjoyable for people with HFpEF. ^{1 2 3 6 7}

Who Is on the Research Team?

Bunny Pozehl, PhD

Principal Investigator

University of Nebraska

Windy W Alonso, PhD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for adults with a type of heart failure where the heart muscle pumps normally but is stiff (HFpEF). They must have been diagnosed via echocardiogram in the last 2 years, be on stable heart medication for at least a month, and meet certain criteria or show evidence of HFpEF.

Inclusion Criteria

My medication has not changed in the last 30 days.

You have had a heart ultrasound in the past 24 months.

My heart pumps blood well, with an ejection fraction of 50% or more.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cardiopulmonary Exercise Testing (CPET) and Run-in Period

Participants undergo CPET to develop an exercise prescription and ensure safety, followed by a run-in period with 3 monitored sessions in cardiac rehabilitation and study orientation.

4 weeks

3 visits (in-person)

Intervention

Participants are randomized into one of three groups: HEART Camp, HEART Camp Connect, or Enhanced Usual Care. Intervention includes coaching sessions and exercise training.

12 months

Weekly visits (in-person or virtual) for first 3 months, bi-weekly thereafter

Self-regulated Exercise

Participants are expected to self-regulate exercise without coaching support.

6 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention period.

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• HEART Camp
• HEART Camp Connect

Trial Overview

The study tests if coaching helps patients with HFpEF exercise more. It compares three groups: one gets usual care, another adds in-person coaching, and the third has virtual coaching. All participants receive fitness center access, a watch, and a heart rate monitor to use during exercise.

How Is the Trial Designed?

Group I: HEART Camp Connect Experimental Treatment 1 Intervention

Participants in the HEART Camp Connect group will be provided paid, virtual access to the medical fitness center and virtual coaching by a trained coach via videoconference. Participants will also receive automated, asynchronous motivational electronic messaging if they are below the weekly adherence threshold.

Group II: HEART Camp Experimental Treatment 1 Intervention

Participants in the HEART Camp group will be provided paid, in-person access to the medical fitness center and in-person coaching by a trained coach.

Group III: Enhanced Usual Care Active Control 1 Intervention

Participants in the Enhanced Usual Care group will be provided paid virtual access to the medical fitness center and virtual availability of the medical fitness center staff and study personnel for participant-initiated questions.

HEART Camp is already approved in United States for the following indications:

Approved in United States as HEART Camp for:

• Heart failure with preserved ejection fraction (HFpEF)

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Published Research Related to This Trial

In a meta-analysis of 276 patients with heart failure with preserved ejection fraction (HFPEF), exercise training significantly improved cardiorespiratory fitness (CRF) and quality of life, indicating its efficacy as a non-pharmacological intervention.

Despite the improvements in CRF and quality of life, exercise training did not lead to significant changes in left ventricular systolic or diastolic function, suggesting that while exercise is beneficial, it may not directly alter heart muscle function in HFPEF patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in patients with heart failure and preserved ejection fraction: meta-analysis of randomized control trials. Pandey, A., Parashar, A., Kumbhani, D., et al.[2022]

A study involving 204 heart failure patients found that improving negative attitudes, self-efficacy, and relapse management significantly contributed to long-term adherence to exercise regimens.

The HEART Camp intervention demonstrated that addressing psychological and behavioral factors is crucial for helping heart failure patients maintain an exercise routine, which is essential for their overall health and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative Attitudes, Self-efficacy, and Relapse Management Mediate Long-Term Adherence to Exercise in Patients With Heart Failure. Alonso, WW., Kupzyk, K., Norman, J., et al.[2022]

A 9-week exercise training intervention for patients with heart failure with preserved ejection fraction (HFpEF) was found to be feasible and safe, with participants attending 88% of sessions and completing 94% of assessments.

The intervention led to significant improvements in quality of life and exercise tolerance, as measured by the Minnesota Living With Heart Failure Questionnaire and the 6-minute walk test, although it did not significantly affect peak VO2.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Training in Patients With Heart Failure With Preserved Ejection Fraction: A Community Hospital Pilot Study. Bean, G., Mou, J., Pflugeisen, B., et al.[2021]

Exercise training is safe for patients with heart failure and significantly improves their health status and exercise capacity, while also reducing abnormal physiological changes associated with the condition.

Controlled studies and meta-analyses indicate that exercise training leads to a modest reduction in clinical events for heart failure patients, highlighting the need for further research to optimize exercise regimens for different patient subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in congestive heart failure: risks and benefits. Keteyian, SJ.[2013]

A supervised exercise training program for 12 patients with heart failure was found to be feasible and safe, with no cardiovascular events occurring during the training year.

Participants showed improvements in quality of life and reductions in NT-proBNP levels, indicating a potential decrease in heart failure severity, while also experiencing a slight increase in left ventricular ejection fraction (LVEF).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing a cardiac training group for patients with heart failure: the "HIP-in-Würzburg" study. Güder, G., Wilkesmann, J., Scholz, N., et al.[2022]

The HEART Camp intervention significantly improved exercise adherence in adults with heart failure with preserved ejection fraction (HFpEF), with adherence rates increasing from 14% to 43% at 12 months and 0% to 56% at 18 months compared to usual care.

Participants with HFpEF also showed significant improvements in physical function and health status, as evidenced by better performance on the 6-minute walk test and higher scores on the Kansas City Cardiomyopathy Questionnaire, indicating that the intervention effectively enhances both exercise adherence and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The HEART Camp Exercise Intervention Improves Exercise Adherence, Physical Function, and Patient-Reported Outcomes in Adults With Preserved Ejection Fraction Heart Failure. Alonso, WW., Kupzyk, KA., Norman, JF., et al.[2023]

In a systematic review of 19 studies involving 720 patients with heart failure with preserved ejection fraction (HFpEF), inspiratory muscle training was found to be the most effective exercise intervention for improving aerobic capacity, measured by peak oxygen consumption (VO2 peak).

High-intensity interval training and combined aerobic and resistance exercise also showed significant improvements in VO2 peak, suggesting that these types of exercise should be included in rehabilitation programs for patients with HFpEF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Exercise Interventions on Aerobic Capacity in Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction: Systematic Review and Network Meta-Analysis. Gomes-Neto, M., Rodrigues Durães, A., Roever, L., et al.[2023]

A systematic review of 16 randomized controlled trials found that physical exercise significantly improves exercise capacity and quality of life in patients with heart failure with preserved ejection fraction (HFpEF), particularly through enhancements in peak oxygen uptake (VO2) and walking distance.

Moderate-intensity exercise training was shown to be more effective than high-intensity training for improving these outcomes, suggesting that longer durations of moderate exercise may provide greater benefits for patients with HFpEF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Exercise Modalities for the Management of Heart Failure With Preserved Ejection Fraction: A Systematic Review and Meta-Analysis. Guo, Y., Xiao, C., Zhao, K., et al.[2023]

The Ex-DHF trial is a significant multicenter study involving 320 patients with heart failure with preserved ejection fraction (HFpEF) that aims to determine the long-term effects of a 12-month supervised exercise training program on various health outcomes.

Preliminary results from smaller studies suggest that structured exercise training can improve exercise capacity and quality of life in HFpEF patients, but this trial will provide more definitive evidence on its impact on mortality, hospitalizations, and overall health-related quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in Diastolic Heart Failure (Ex-DHF): rationale and design of a multicentre, prospective, randomized, controlled, parallel group trial. Edelmann, F., Bobenko, A., Gelbrich, G., et al.[2018]

Citations

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