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Exercise Training for Heart Failure
N/A
Recruiting
Led By Kanokwan Bunsawat, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
New York Heart Association (NYHA) functional class II or III
Be older than 18 years old
Must not have
NYHA Class IV or HF that cannot be stabilized on optimized pharmacotherapy
Acute coronary syndrome, infiltrative cardiomyopathy, or myocarditis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline skeletal muscle blood flow at 8 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will study how well exercise training can improve symptoms and quality of life in patients with heart failure with preserved ejection.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the intervention involves exercise training rather than medication, side effects may include typical post-exercise symptoms like muscle soreness or fatigue. However, risks are generally low and will be monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart condition limits my physical activity but I can still perform light tasks.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My heart failure is severe and cannot be managed with medication.
Select...
I have a heart condition such as acute coronary syndrome, infiltrative cardiomyopathy, or myocarditis.
Select...
I am not currently on hormone replacement therapy.
Select...
I cannot do exercises that require straightening my knee due to physical limitations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline six-minute walk test distance at 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline six-minute walk test distance at 8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Muscle blood flow
Six-minute walk test
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,642 Total Patients Enrolled
Kanokwan Bunsawat, PhDPrincipal InvestigatorVA Salt Lake City Health Care System, Salt Lake City, UT
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 am 18 or older and can sign a consent form.I have a heart condition such as acute coronary syndrome, infiltrative cardiomyopathy, or myocarditis.I am not pregnant and unlikely to become pregnant, as I am postmenopausal.My heart condition limits my physical activity but I can still perform light tasks.I am not currently on hormone replacement therapy.I cannot do exercises that require straightening my knee due to physical limitations.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise training
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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