Exercise Intolerance in Elderly Patients With Diastolic Heart Failure
- Conditions
- Heart Failure, DiastolicObesity
- Registration Number
- NCT00959660
- Lead Sponsor
- Wake Forest University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Exercise Capacity 20 weeks 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.
- Secondary Outcome Measures
Name Time Method Quality of Life 20 weeks 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.
Body Composition 20 weeks Total Body Fat Mass and Total Non-bone Lean Mass via DEXA
Thigh Muscle Composition 20 weeks Thigh Skeletal Muscle and Subcutaneous Fat via MRI
Trial Locations
- Locations (1)
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Wake Forest University Health Sciences🇺🇸Winston-Salem, North Carolina, United States