The Effect of a High Fiber Diet and High-Intensity Interval Exercise in Patients With HFpEF
- Conditions
- Heart Failure With Preserved Ejection Fraction
- Interventions
- Behavioral: High Intensity Interval ExerciseBehavioral: Dietary Approaches to Stop Hypertension (DASH) DietBehavioral: Exercise + DASH Diet
- Registration Number
- NCT05236413
- Lead Sponsor
- University of Virginia
- Brief Summary
This study is trying to find out how best to improve common measures of health and survival in those diagnosed with heart failure with preserved ejection fraction (HFpEF) through the implementation of 4 weeks of an exercise training program consisting of high intensity interval training, dietary approaches to stop hypertension (DASH diet), or a combination of the two. Currently there are not established guidelines that have been shown to improve clinical end points in those with this HFpEF.
- Detailed Description
In the face of a rapidly growing population of older, HFpEF patients, there remains a need to identify ideal rehabilitative therapies to enhance improvements in the physical function of these patients. Pharmacological trials in this population have been characterized by a failure to significantly improve exercise tolerance and hard clinical outcomes and this is likely due to their singular cardiovascular focus. Exercise appears to be a promising intervention to improve cardiorespiratory fitness and reduce cardiovascular risk. Further, evidence-based dietary guidelines for patients with heart failure are lacking. Although a high-protein, low-carbohydrate diet is associated with improvements in traditional CV risk markers in patients with heart failure, it may raise cardiovascular risk in this population by adversely affecting endothelial function, increasing susceptibility to myocardial ischemia, and by inducing a pro-inflammatory state due to increased bacterial and LPS translocation through the ischemic gut. Thus, the investigators will explore the effects of the high-carbohydrate, high-fiber DASH diet due to its potential to have salutary effects on vascular risk in this population. In this study, the investigators will examine the singular and combined effects of exercise and a DASH diet in patients with HFpEF on markers of cardiovascular risk.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
- ≥40 years of age
- Diagnosed with heart failure with preserved ejection fraction
- NYHA class II-III symptoms
- Physician clearance to undergo exercise training
- Physician clearance to consume DASH diet
- Complete COVID-19 vaccination status
- Unstable angina
- Myocardial infarction in the past 4 weeks
- Uncompensated heart failure
- NYHA class IV symptoms
- Complex ventricular arrhythmias
- Musculoskeletal contraindications to stationary bicycling exercise
- Symptomatic severe aortic stenosis
- Acute pulmonary embolus
- Acute myocarditis
- Uncontrolled hypertension
- Medication non-compliance
- Unable to follow DASH diet
- Food allergies (Nuts, wheat)
- Pregnant women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Intensity Interval Exercise High Intensity Interval Exercise Enrolled patients will perform supervised exercise on 3 nonconsecutive days of the week for 4 weeks. Dietary Approaches to Stop Hypertension (DASH) Diet Dietary Approaches to Stop Hypertension (DASH) Diet Enrolled patients will have all of their food prepared for them by a registered dietician for the duration of the study period. The diet will consist of a high fiber content DASH diet. Exercise + DASH Diet Exercise + DASH Diet Enrolled subjects will undergo both the exercise training visits and be provided with the DASH diet.
- Primary Outcome Measures
Name Time Method VO2peak 4 weeks Change in VO2peak (L/min) measured pre- and post-intervention
- Secondary Outcome Measures
Name Time Method Body Composition 4 weeks Changes in lean and fat mass (grams) will be measured via dual-energy x-ray absorptiometry pre-and post-intervention
Diastolic Function 4 weeks E' and A' (cm/s) will be used to calculate the E'/A' ratio to assess for diastolic dysfunction and be measured by echocardiogram pre- and post-intervention
Pittsburgh Sleep Quality Index 4 weeks Sleep quality and sleep disturbances over the pervious month will be measured with the Pittsburgh sleep quality index (PSQI). The PSQI include 19 item self directed questions which look at a measures of sleep quality and a disturbances. It also includes 5 questions to be answered by a roommate (if available) regarding the patients sleep habits.
Global Longitudinal Strain 4 weeks Global longitudinal strain (%) will be used to assess changes in cardiac contractile function and be measured by echocardiogram pre- and post-intervention
Circadian Type Questionnaire 4 weeks The Circadian Type Questionnaire is an 19 item VAS that is used to assess someones ability to change their sleeping habits.
Blood pressure 4 weeks Changes in measures of central and brachial blood pressure (mmHg) at pre- and post-intervention
Minnesota Living with Heart Failure Questionnaire 4 weeks Disease specific quality of life will be measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). he MLHFQ consists of 21 items that assess physical and emotional domains. Each item/question is scored on a 0-5 Likert scale.
Epworth Sleepiness Questionnaire 4 weeks The Epworth sleepiness questionnaire is an 8 item questionnaire that measures how likely someone would be to fall asleep in 8 different scenarios. Each item is graded on a 4 point likert scale ranging from "would never nod off" to "high chance of nodding off".
Ejection Fraction 4 weeks Ejection fraction (%) will be used to assess changes in cardiac contractile function and be measured by echocardiogram pre- and post-intervention
Carotid-Femoral Pulse Wave Velocity 4 weeks Changes in arterial stiffness as measured by carotid-femoral pulse wave velocity (m/s) at pre- and post-intervention
Physical Activity Enjoyment Scale Immediately after the intervention Subject enjoyment of exercise will be measured using the Physical Activity Enjoyment Scale. This is an 18 item questionnaire which assess how subjects feel about the exercise they have been performing. Questions are scored using a 7-point likert scale
Sleep Apnea 4 weeks Changes in sleep apnea will be measured using a WatchPAT device. This device measured finger peripheral arterial tone and measures arterial volume changes in the finger. This reflect changes in sympathetic tone and is associated with sleep disordered breathing.
Trial Locations
- Locations (1)
University of Virginia University Hospital
🇺🇸Charlottesville, Virginia, United States