Exercise Training Effect in Patients With HF and PEF

Study Overview
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Brief Summary
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The purpose of this is to develop and implement a pilot study that will demonstrate the ability to recruit, enroll, retain, conduct exercise training, and collect pre and post outcomes on the effect of exercise training on quality of life (QOL) and exercise capacity in patients with a diagnosis of heart failure with preserved ejection fraction (HFPEF).

Official Title
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Exercise Training Effect on Quality of Life and Exercise Capacity in Patients With Heart Failure and Preserved Ejection Fraction: A Pilot Study

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Exercise Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 55 years (Interested in capturing mean ages close to age 65 as many HF initiatives are based on this age group and HF development increases with aging). Diagnosis of HFPEF stable NYHA Stage II- III with an EF of ≥ 45% Stabilized on cardiac medications and post hospitalization > 4 weeks Ability to participate in exercise testing and training. Referral from Cardiologist or primary care physician. Exclusion Criteria: Unstable Angina Uncontrolled diabetes Moderate to severe aortic stenosis Uncontrolled hypertension Systolic BP>150 mm Hg or Diastolic BP >100 mm Hg Valvular heart disease Untreated coronary artery stenosis >50% Arrhythmias Pulmonary disease/COPD Dementia or cognitive impairment VAD or Transplant planned in next 6 months. Current or recent participation in a Cardiac Rehab program within the last six months.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Training<br> | Behavioral: Exercise Training<br>* Study subjects will receive medically supervised aerobic and resistance exercise training for 1 hour per session, 3 times per week for 6 weeks at the Cardiac Rehab center and then transition to home or YMCA partnership based exercise with staff follow-up contact for an additional 3 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life (QOL) score pre and post exercise training (ET). |  | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in exercise capacity/tolerance pre and post ET using Cardiopulmonary Exercise Testing. | Symptom limited treadmill testing with expired gas measurement and analysis. Exercise capacity measured as Peak Vo2 (peak exercise oxygen uptake) in ml/min/kg. Continuous monitoring of 12 lead electrocardiogram and blood pressure measured every 2 minutes. Peak Vo2 defined as highest Vo2 value of the last 30 seconds before termination of exercise. Exercise time and peak workload will be measured for exercise tolerance. | 9 weeks | 
| Demonstrated ability to coordinate patient transition from clinic to home or YMCA partnership based exercise program with weekly staff follow-up within the study timeline. |  | 9 weeks | 
| Capture 90 day hospital readmission data starting with study enrollment date and within the participants' study timeline. |  | 90 days |