Exercise Coaching for Heart Failure

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

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the treatment HEART Camp for heart failure?

Research shows that the HEART Camp exercise program helps people with heart failure stick to their exercise routines, which improves their physical function and quality of life. Exercise training, like that in HEART Camp, has been found to significantly enhance exercise capacity and some heart function indicators in patients with heart failure with preserved ejection fraction. ^{1 2 3 4 5}

Is exercise coaching safe for people with heart failure?

Exercise is generally safe for people with heart failure and can improve their health and quality of life. Studies show that exercise training helps with exercise capacity and reduces some symptoms of heart failure. ^{1 2 3 6 7}

What makes the HEART Camp treatment unique for heart failure with preserved ejection fraction?

HEART Camp is unique because it focuses on improving adherence to exercise through a multicomponent behavioral intervention, which is crucial for patients with heart failure with preserved ejection fraction (HFpEF) who often struggle to stick with exercise routines. This approach is different from other treatments as it combines exercise with strategies to change behavior, aiming to enhance long-term exercise commitment and improve patient outcomes. ^{1 2 3 8 9}

Research Team

Windy W Alonso, PhD

Principal Investigator

University of Nebraska

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Negative Attitudes, Self-efficacy, and Relapse Management Mediate Long-Term Adherence to Exercise in Patients With Heart Failure. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Exercise Training in Patients With Heart Failure With Preserved Ejection Fraction: A Community Hospital Pilot Study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Physical Exercise Modalities for the Management of Heart Failure With Preserved Ejection Fraction: A Systematic Review and Meta-Analysis. [2023]

5. England 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. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. Germany pubmed.ncbi.nlm.nih.gov

Establishing a cardiac training group for patients with heart failure: the "HIP-in-Würzburg" study. [2022]

8. United States 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Exercise training in patients with heart failure and preserved ejection fraction: meta-analysis of randomized control trials. [2022]