Exercise Intolerance in Elderly Patients With Diastolic Heart Failure

Wake Forest University100 enrolled

Overview

The purpose of this study is to examine the effects of weight loss via hypocaloric diet, aerobic exercise training, combined hypocaloric diet and exercise training, and attention control in patients with heart failure and a normal ejection fraction (HFNEF) and body mass index greater than or equal to 30.

Heart failure with a normal ejection fraction (HFNEF, previously termed diastolic heart failure), accounts for the majority of heart failure cases in the population \> 65 years old and has been recognized as a true geriatric syndrome. Exercise intolerance is the primary chronic symptom of HFNEF and a major determinant of these patients' severely reduced quality of life; however little is known regarding its pathophysiology and treatment. Therefore, our work has focused on understanding the pathophysiology of exercise intolerance in HFNEF and developing and testing interventions that may improve this pivotal outcome in this highly prevalent disorder of older persons. The aims of the proposed study are to conduct a randomized, controlled, single-blinded, 2x2 design trial to examine the effects of weight loss via hypocaloric diet, aerobic exercise training, combined hypocaloric diet and exercise training, and attention control in patients with HFNEF and body mass index \>30 in order to test the following hypotheses: 1) Both weight loss and exercise training will improve exercise intolerance and quality of life in older, obese patients with HFNEF; 2) The combination of weight loss and exercise training will produce complementary effects on body and thigh muscle composition and additive improvements in exercise intolerance in HFNEF; 3) Improvements in exercise intolerance will correlate with improvements in lean body mass, reversal of adverse thigh muscle remodeling, and increased thigh muscle capillarity. The study has the potential to significantly advance our understanding of exercise intolerance and its treatment in the large population of older persons with HFNEF.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Heart Failure, Diastolic Obesity

Interventions

ExerciseBEHAVIORAL

walking, treadmill and bicycle exercise

Dietary InterventionDIETARY_SUPPLEMENT

Subjects will be provided meals and instructions for individual food selections.

Diet and exerciseBEHAVIORAL

Subjects will be provided meals and instructions for individual food selections and will undergo walking, treadmill and bicycle exercise.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Heart failure clinical score greater than or equal to 3 * Age 60 and over * Normal ejection fraction greater than or equal to 50% * BMI greater than or equal to 30 Exclusion Criteria: * Valvular heart disease * Significant change in cardiac medication \<4 weeks * Uncontrolled hypertension * Recent or debilitating stroke * Cancer or other noncardiovascular conditions with life expectancy less than 2 years * Significant Anemia * Renal insufficiency (creatinine \>2.5mg/dl) * Psychiatric disease- uncontrolled major psychoses, depressions, dementia, or personality disorder * Plans to leave area within 6 months * Refuses informed consent * Failure to pass screening test:pulmonary function, echocardiogram,or exercise

Locations (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Exercise Capacity

Exercise capacity assessed as Peak VO2 (ml/kg/min) via treadmill cardiopulmonary exercise testing using the modified Naughton protocol to the end point of exhaustion.

Time frame: 20 weeks

Secondary Outcomes

Quality of Life

Heart failure-specific quality of life was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ) on a range 0-100; higher scores indicate better quality of life.

Time frame: 20 weeks

Body Composition

Total Body Fat Mass and Total Non-bone Lean Mass via DEXA

Time frame: 20 weeks

Thigh Muscle Composition

Thigh Skeletal Muscle and Subcutaneous Fat via MRI

Time frame: 20 weeks

Data from ClinicalTrials.gov

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