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临床试验/NCT05236413
NCT05236413招募中不适用

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

University of Virginia1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
36
试验地点
1
主要终点
VO2peak

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes assessor will be blinded to group allocations. Subjects will know which group they have been randomized to.

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •≥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

排除标准

  • •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

研究组 & 干预措施

High Intensity Interval Exercise

Experimental

Enrolled patients will perform supervised exercise on 3 nonconsecutive days of the week for 4 weeks.

干预措施: High Intensity Interval Exercise (Behavioral)

Dietary Approaches to Stop Hypertension (DASH) Diet

Experimental

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.

干预措施: Dietary Approaches to Stop Hypertension (DASH) Diet (Behavioral)

Exercise + DASH Diet

Experimental

Enrolled subjects will undergo both the exercise training visits and be provided with the DASH diet.

干预措施: Exercise + DASH Diet (Behavioral)

结局指标

主要结局

VO2peak

时间窗: 4 weeks

Change in VO2peak (L/min) measured pre- and post-intervention

次要结局

  • Body Composition(4 weeks)
  • Diastolic Function(4 weeks)
  • Pittsburgh Sleep Quality Index(4 weeks)
  • Global Longitudinal Strain(4 weeks)
  • Circadian Type Questionnaire(4 weeks)
  • Blood pressure(4 weeks)
  • Minnesota Living with Heart Failure Questionnaire(4 weeks)
  • Epworth Sleepiness Questionnaire(4 weeks)
  • Ejection Fraction(4 weeks)
  • Carotid-Femoral Pulse Wave Velocity(4 weeks)
  • Physical Activity Enjoyment Scale(Immediately after the intervention)
  • Sleep Apnea(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Siddartha Angadi

Assistant Professor

University of Virginia

研究点 (1)

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