Study of the Effects Caloric Restriction and Exercise Training in Patients With Heart Failure and a Normal Ejection Fraction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Peak Exercise Oxygen Consumption (VO2)
Study Overview
Brief Summary
The purpose of this study is to examine the effects of weight loss via hypocaloric diet (CR)and aerobic exercise (AT) compared to the effects of weight loss via hypocaloric diet (CR), aerobic training (AT)and resistance training (RT).
Detailed Description
Heart failure with preserved ejection fraction (HFPEF) is the most common form of HF, is nearly unique to the older population, particularly older women, and is increasing in prevalence. Exercise intolerance, with severe exertional dyspnea and fatigue, is the primary manifestation of chronic HFPEF and is a major determinant of these patients' severely reduced quality of life (QOL). However, its pathophysiology is poorly understood and its optimal treatment remains undefined.
Our recent data and others' indicate that in older HFPEF patients, both increased adiposity and abnormalities in skeletal muscle are major contributors to exercise intolerance and potential therapeutic targets. Obesity is one of the strongest risk factors for HFPEF, and is a robust predictor of physical disability in older persons. The investigator recently reported that in HFPEF compared to age-matched controls, percent total and leg lean mass are significantly reduced and independently predict exercise capacity.
Using MRI and needle biopsy of the thigh muscle, the investigators found increased fat infiltration, reduced capillary density and percent type I oxidative fibers, and trends for reduced muscle mitochondrial mass and function. Reduced exercise capacity was related to each of these muscle abnormalities, supporting their important role in HFPEF.
Diet, with or without aerobic exercise, can increase exercise capacity and quality of life in older obese persons with a variety of disorders, but usually results in significant loss of skeletal muscle mass, which could potentially have adverse long term consequences. The purpose of this trial is to determine if addition of resistance training to diet plus aerobic exercise training can improve skeletal muscle mass and function in HFPEF.
Multiple lines of evidence and our preliminary data indicate that resistance training (RT) may be an ideal addition to CR+AT for HFPEF, since RT reliably increases muscle mass, quality, strength, and function, significantly more than AT, and can prevent nearly 50% of the muscle mass loss during CR.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 60 years or older
- •Ejection fraction ≥ 50%
- •Left Ventricular Diastolic Dysfunction ≥ grade 1
- •BMI ≥ 28 kg/m2
- •HF symptoms/ signs by cardiologist review, using NHANES HF Clinical Score >/= 3 or Rich et al. criteria for HF
Exclusion Criteria
- •Valvular heart disease as the primary etiology of CHF (congestive heart failure)
- •Significant change in cardiac medication or Heart Failure symptoms <6 weeks
- •Hospitalization or urgent care visit <6 weeks
- •Uncontrolled hypertension
- •Uncontrolled diabetes
- •Evidence of significant Chronic Obstructive Pulmonary Disease (COPD)
- •Recent or debilitating stroke
- •Cancer or other noncardiovascular conditions with life expectancy less than 2 years
- •Significant anemia (<10 g/dL Hgb)
- •Significant renal insufficiency (eGFR <30 mL/min/1.73m2)
- •Pregnant or of child-bearing potential
- •Psychiatric disease- uncontrolled major psychoses, depressions, dementia, or personality disorder
- •Plans to leave area within the study period
- •Refuses informed consent -
Arms & Interventions
dietary, and aerobic exercise
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
Intervention: dietary, and aerobic exercise (Behavioral)
dietary, aerobic and resistance training
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
Intervention for resistance training- Additional weight resistant exercise will be added to this arm.
Intervention: dietary, aerobic and resistance training (Behavioral)
dietary, aerobic and resistance training
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
Intervention for resistance training- Additional weight resistant exercise will be added to this arm.
Intervention: dietary, and aerobic exercise (Behavioral)
Outcomes
Primary Outcomes
Peak Exercise Oxygen Consumption (VO2)
Time Frame: 20 weeks
Peak exercise oxygen consumption (VO2) pre and post intervention
Secondary Outcomes
- Thigh Skeletal Muscle Mass(20 weeks)
- Muscle Quality(20 weeks)
- Muscle Strength(20 weeks)
- Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score(20 weeks)
- Quality of Life Measured by Short Form 36 Item Questionnaire (SF-36)(20 weeks)
- Skeletal Muscle Mass(20 weeks)
- Thigh Muscle Composition(20 weeks)