RecruitingNot ApplicableNCT05236413

The Effect of a High Fiber Diet and High-Intensity Interval Exercise in Patients With HFpEF

The Effect of a High Fiber Diet and High-Intensity Interval Exercise in Patients With Heart Failure With Preserved Ejection Fraction


Sponsor

University of Virginia

Enrollment

36 participants

Start Date

Apr 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 Years

Inclusion Criteria6

  • ≥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

Exclusion Criteria14

  • 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

Interventions

BEHAVIORALHigh Intensity Interval Exercise

Patients will be required to report for three sessions of supervised stationary cycling exercise per week over a period of 4-weeks. Training heart rates will be determined based on the pre-testing VO2peak and peak heart rate (PHR). All sessions will be supervised by trained personnel. Patients will start with eight intervals of 2-min duration at 80-85% of PHR, separated by 2 min of recovery at 50% of PHR, progressing to four, 4-min intervals at 90-95% PHR, separated by 3 min at 50% PHR by the end of week 2. Each training session will begin with a 10-min warm-up at 50% of PHR and end with a 5-min cool down at 50% PHR. Subjects will be weighed prior to every exercise session and weight tracked to ensure that their volume status hasn't changed significantly. Subjects will be instructed to maintain usual levels of physical activity and usual diet during the study and not to make any modifications to the same.

BEHAVIORALDietary Approaches to Stop Hypertension (DASH) Diet

Patients will be interviewed with regard to their food/religious preferences and food allergies and a 7-day rotating meal plan will be designed per their preferences along with a registered dietitian. This will ensure that patients receive food that is acceptable to them. Participants will then be provided pre-packaged meals for 4-weeks with macronutrient compositions as follows - (Carbohydrates -55-60%, Protein -15-20%, Fat -15-25%, Fiber -35-45g/day). All foods will be labeled, sealed, and packed for weekly delivery and will be designed such that they can be refrigerated or frozen and stored without significant alterations to nutritional content. All food will be prepared by the UVA Hospital Nutrition Services department in conjunction with a registered dietician. Deviations (if any) from the study meal plan will be recorded by the participants in a food record provided at the start of each diet intervention period.

BEHAVIORALExercise + DASH Diet

Patients will undergo both the exercise training intervention and DASH diet as explained above.


Locations(1)

University of Virginia University Hospital

Charlottesville, Virginia, United States

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NCT05236413


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