Exercise Intolerance in Elderly Patients With Diastolic Heart Failure (SECRET)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Heart Failure, Diastolic Obesity |
Behavioral: Exercise Dietary Supplement: Dietary Intervention Behavioral: Diet and exercise Other: Attention Control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Study of the Effect of Caloric Restriction and Exercise Training in Patients With Heart Failure and a Normal Ejection Fraction.(SECRET) |
- Exercise capacity [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
- Body and thigh muscle composition, Quality of Life [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Exercise Training
Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individualized exercise prescription will be developed for each subject.
|
Behavioral: Exercise
walking, treadmill and bicycle exercise
|
|
Active Comparator: Dietary Intervention
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.
|
Dietary Supplement: Dietary Intervention
Subjects will be provided meals and instructions for individual food selections.
|
|
Active Comparator: Attention control
Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status.
|
Other: Attention Control
control group- continue their previously randomized life style
|
|
Active Comparator: Diet and Exercise
The diet and exercise group is a combination of the two groups previously described.
|
Behavioral: Exercise
walking, treadmill and bicycle exercise
Behavioral: Diet and exercise
Combination of the exercise and diet group as previously described.
|
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.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Dalane W Kitzman, MD | 336 716 3274 ext 6-3274 | dkitzman@wfubmc.edu |
| Contact: Kathy P Stewart, RDCS | 336 716 6339 ext 6-6339 | kstewart@wfubmc.edu |
| United States, North Carolina | |
| Wake Forest University Health Sciences | Recruiting |
| Winston Salem, North Carolina, United States, 271757 | |
| Contact: Dalane W Kitzman, MD 336-716-3274 ext 6-3274 dkitzman@wfubmc.edu | |
| Contact: Kathy P Stewart, RDCS 336 716 6339 ext 6-6339 kstewart@wfubmc.edu | |
| Principal Investigator: Dalane W Kitzman, MD | |
| Principal Investigator: | Dalane W Kitzman, MD | Wake Forest University |
More Information
No publications provided
| Responsible Party: | Dalane W. Kitzman, Professor Internal Medicine Cardiology/Gerontology, Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT00959660 History of Changes |
| Other Study ID Numbers: | IRB00005668, R37AG018915 |
| Study First Received: | August 14, 2009 |
| Last Updated: | January 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Wake Forest University:
|
Diastolic heart failure Heart Failure Elderly Obesity |
Additional relevant MeSH terms:
|
Heart Failure Obesity Heart Failure, Diastolic Heart Diseases Cardiovascular Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013