92 Participants Needed

Exercise Program for Heart Failure

EG
EP
BS
Overseen ByBen Stephenson
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: University of Virginia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This study is trying to find out whether performing a hybrid aerobic-resistance exercise training program (titled PRIME: Peripheral Remodeling via Intermittent Muscular Exercise) results in better health outcomes than the traditional exercise training program (called COMBO) that is used in individuals with heart failure with reduced ejection fraction (HFrEF). Participants will be randomized (like the flip of a coin) to either PRIME (investigational) or the traditional exercise program (standard of care).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment COMBO, Traditional Exercise Training Program, Standard of Care Exercise Program, PRIME, Peripheral Remodeling via Intermittent Muscular Exercise for heart failure?

Research shows that exercise training is safe and improves health status and exercise capacity in heart failure patients, helping to reduce abnormal changes in the body caused by the condition. Additionally, peripheral muscle training can lead to significant muscle adaptation with minimal stress on the heart, which may benefit heart failure patients who cannot engage in traditional exercise.12345

Is exercise training safe for people with heart failure?

Exercise training is generally safe for people with heart failure, as studies have shown it improves health status and exercise capacity, and reduces some of the negative effects of heart failure.26789

How does the exercise program for heart failure differ from other treatments?

This exercise program for heart failure is unique because it combines moderate-intensity aerobic and resistance training, and includes a preliminary phase called Peripheral Remodeling through Intermittent Muscular Exercise (PRIME) to enhance aerobic capacity and muscle strength more effectively than traditional exercise programs.710111213

Research Team

Jason David Allen | UVA School of ...

Jason Allen, PhD

Principal Investigator

University of Virginia

Eligibility Criteria

This trial is for individuals over 65 with heart failure and reduced ejection fraction (HFrEF), specifically those who can communicate well, have cardiologist approval, and a hemoglobin level of at least 10.0 g/dL. It's not for people with uncontrolled diabetes, recent heart attacks or embolism, severe valve disease needing surgery, new atrial fibrillation, worsening symptoms in the past few days, significant ischemia during low exercise levels, or certain other acute conditions.

Inclusion Criteria

My cardiologist has approved my participation after reviewing my medical records and examining me.
I can understand and communicate about the study, and I can legally consent.
Your hemoglobin level must be at least 10.0 grams per deciliter.
See 2 more

Exclusion Criteria

I have not had a blood clot in the last 6 weeks.
I have severe narrowing of my aortic valve.
I need surgery for a heart valve problem causing backflow.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Treatment

Participants undergo 4 weeks of either PRIME or COMBO exercise training

4 weeks

Phase 2: Treatment

All participants undergo 8 weeks of progressive whole-body COMBO training

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

  • COMBO
  • PRIME
Trial OverviewThe study compares a novel exercise program called PRIME against the traditional COMBO exercise regimen to see which one leads to better health outcomes for older patients with HFrEF. Participants will be randomly assigned to either the investigational PRIME program or the standard COMBO training.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: PRIME + COMBOExperimental Treatment2 Interventions
PRIME training (Phase 1), followed by 8 weeks of progressive whole-body COMBO training.
Group II: COMBO onlyExperimental Treatment1 Intervention
4 weeks of standard progressive whole-body aerobic plus resistance training (COMBO) followed by 8 weeks continued COMBO training.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials
802
Recruited
1,342,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Findings from Research

A 6-week dynamic exercise program focusing on individual muscle groups led to significant increases in quadriceps strength and muscle fiber area in 10 healthy subjects, while maintaining low heart stress levels.
This 'peripheral' training approach may be beneficial for patients with heart conditions, as it allows for muscle adaptation without the high central circulatory demands of traditional exercise, although its effects on cardiac patients still need to be explored.
Adaptation to peripheral muscle training.Gaffney, FA., Grimby, G., Danneskiold-Samsøe, B., et al.[2008]
Exercise training is safe for patients with heart failure and leads to significant improvements in health status and exercise capacity, while also helping to reduce abnormal heart function associated with the condition.
The benefits of exercise training, including a modest reduction in clinical events, are linked to the amount of exercise performed, highlighting the need for future research to determine the best exercise strategies for different patient groups.
Role and benefits of exercise in the management of patients with heart failure.Keteyian, SJ., Fleg, JL., Brawner, CA., et al.[2021]
Recent studies have established effective exercise testing protocols for patients with peripheral arterial disease and congestive heart failure, leading to significant improvements in exercise performance and quality of life.
The improvements in exercise capacity are primarily due to adaptations in skeletal muscle metabolism rather than increases in heart function or blood flow, highlighting the importance of targeted exercise training in these patient populations.
Exercise physiology in cardiovascular diseases.Hiatt, WR.[2019]

References

Adaptation to peripheral muscle training. [2008]
Role and benefits of exercise in the management of patients with heart failure. [2021]
Exercise physiology in cardiovascular diseases. [2019]
Intermittent versus continuous exercise training in chronic heart failure: a meta-analysis. [2022]
[Physical rehabilitation of patients suffering from chronic heart failure]. [2019]
Impaired Exercise Tolerance in Heart Failure: Role of Skeletal Muscle Morphology and Function. [2022]
PRIME-HF: Novel Exercise for Older Patients with Heart Failure. A Pilot Randomized Controlled Study. [2023]
Exercise and heart failure. [2007]
Effects of aerobic and inspiratory training on skeletal muscle microRNA-1 and downstream-associated pathways in patients with heart failure. [2021]
[Special aspects of physical training during the rehabilitation stage of coronary patients]. [2007]
[Exercise training improves activities of daily living in elderly patients with congestive heart failure]. [2019]
Effects of machine-assisted cycling on exercise capacity and endothelial function in elderly patients with heart failure. [2019]
Benefits of exercise training in the treatment of heart failure: study with a control group. [2022]