35 Participants Needed

Exercise Training for Heart Failure

PJ
PJ
Overseen ByP Jon White, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that heart failure must be stabilized on optimized pharmacotherapy, which suggests that you may need to continue certain medications.

What data supports the effectiveness of this treatment for heart failure?

Research shows that exercise training is safe and beneficial for heart failure patients, improving their heart and lung function, overall health, and quality of life. While it may not directly reduce death rates, it helps patients feel better and live more actively.12345

Is exercise training safe for people with heart failure?

Yes, exercise training is generally considered safe for people with heart failure when they are properly evaluated and monitored. Studies have shown that it can be safely performed and is recommended as part of the treatment for stable heart failure patients.16789

How is exercise training different from other treatments for heart failure?

Exercise training is unique because it improves heart failure symptoms by enhancing exercise capacity and quality of life without worsening heart function. Unlike medications, it involves physical activity like aerobic and resistance exercises, which help the heart and muscles adapt positively, reducing the risk of hospitalization and possibly mortality.14101112

What is the purpose of this trial?

Heart failure with preserved ejection (HFpEF) disproportionately affects Veterans and is the number one reason for hospital discharge in the VA Health Care System. Exercise intolerance is a common complication experienced by patients with HFpEF, perpetuating physical inactivity and accelerating disease progression. This research proposal aims to elucidate mechanisms responsible for inadequate skeletal muscle blood flow and exercise intolerance in patients with HFpEF compared with healthy controls as well as following 8 weeks of exercise training in patients with HFpEF only.

Research Team

KB

Kanokwan Bunsawat, PhD

Principal Investigator

VA Salt Lake City Health Care System, Salt Lake City, UT

Eligibility Criteria

This trial is for adults with heart failure who can consent, have a specific type of heart failure (HFpEF) where the heart pumps well but is stiff, and show certain blood markers. It's not for those with severe heart issues, orthopedic limits that prevent exercise, women on hormone therapy, smokers, or pregnant women.

Inclusion Criteria

My heart condition limits my physical activity but I can still perform light tasks.
Plasma Brain Natriuretic Peptide (BNP) >200 pg/mL or NT-proBNP 400 pg/mL at enrollment
Left Ventricular Ejection Fraction (LVEF) > 50%

Exclusion Criteria

My heart failure is severe and cannot be managed with medication.
My heart failure is not due to a major untreated valve problem, except for a specific type of leaky heart valve caused by heart muscle weakness.
I have a heart condition such as acute coronary syndrome, infiltrative cardiomyopathy, or myocarditis.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cross-sectional Comparison

Cross-sectional comparison of patients with HFpEF and healthy controls

Not specified

Exercise Training

Patients with HFpEF undergo 8 weeks of supervised knee extensor exercise training

8 weeks
3 visits per week (in-person)

Follow-up

Participants are monitored for changes in exercise tolerance and muscle blood flow

4 weeks

Treatment Details

Interventions

  • Exercise training
Trial Overview The study looks at how well patients with HFpEF respond to an 8-week exercise program compared to healthy people. The focus is on understanding why these patients struggle with exercise by measuring changes in muscle blood flow.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Exercise trainingExperimental Treatment1 Intervention
Patients with HFpEF will participate in the 8 weeks of supervised, two-legged, knee extensor exercise training for 3 days per week. Each exercise session will involve a 5-min warm-up and a 5-min cool-down, and exercise intensity will range between 40%-90% of maximal work rate. Maximal work rate will be re-assessed every two weeks.

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Findings from Research

A study involving 80 patients with chronic heart failure showed that a structured endurance training program was safe, with no reported adverse events, and led to significant improvements in exercise time and quality of life.
The training increased the anaerobic threshold and decreased the ventilatory equivalent for carbon dioxide during submaximal exercise, indicating enhanced exercise capacity, although it did not significantly improve peak oxygen consumption.
Safety and effects of physical training in chronic heart failure. Results of the Chronic Heart Failure and Graded Exercise study (CHANGE)Wielenga, RP., Huisveld, IA., Bol, E., et al.[2007]
Exercise training significantly enhances cardiorespiratory function, functional status, and psychosocial well-being in heart failure patients, which is crucial since exercise tolerance is linked to their overall health outcomes.
While the direct impact of exercise training on morbidity and mortality in heart failure patients remains unclear, it appears to improve quality of life, suggesting that even small gains can lead to a more fulfilling life for these individuals.
Exercise training in heart failure: inpatient and outpatient considerations.Cahalin, LP.[2019]
The HF-ACTION trial aims to determine if exercise training can reduce all-cause mortality and hospitalization in patients with heart failure, involving 36 supervised sessions followed by home-based exercise over a 4-year period.
Exercise training is a low-cost and accessible intervention that may improve health outcomes for heart failure patients, with various physiological and quality-of-life measures being assessed throughout the study.
Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale.Whellan, DJ., O'Connor, CM., Lee, KL., et al.[2007]

References

Safety and effects of physical training in chronic heart failure. Results of the Chronic Heart Failure and Graded Exercise study (CHANGE) [2007]
Exercise training in heart failure: inpatient and outpatient considerations. [2019]
Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale. [2007]
...that exercise training is safe, useful and effective therapy and does not worsen cardiac function in heart failure? [2011]
Experience from controlled trials of physical training in chronic heart failure. Protocol and patient factors in effectiveness in the improvement in exercise tolerance. European Heart Failure Training Group. [2022]
Exercise training in patients with heart failure: clinical outcomes, safety, and indications. [2021]
ExPAAC proceedings: Exercise training for individuals with heart failure. [2012]
[Exercise Training and Physical Activity in Patients with Heart Failure]. [2018]
Establishing a cardiac training group for patients with heart failure: the "HIP-in-Würzburg" study. [2022]
Effects of Concurrent, Within-Session, Aerobic and Resistance Exercise Training on Functional Capacity and Muscle Performance in Elderly Male Patients with Chronic Heart Failure. [2023]
[Effects of continuous physical training on exercise tolerance and left ventricular myocardial function in patients with heart failure]. [2019]
Exercise training in chronic heart failure: mechanisms and therapies. [2022]
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