N/A
Completed N=100
Exercise Intolerance in Elderly Patients With Diastolic Heart Failure
Heart Failure, Diastolic · Obesity
Source: ClinicalTrials.gov NCT00959660 ↗
Enrolled (actual)
100
Serious AEs
3.0%
Results posted
Apr 2018
Primary outcomePrimary: Exercise Capacity — 15.5; 15.5; 14.1; 16.6 ml/kg/min — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exercise Capacity |
15.5; 15.5; 14.1; 16.6 | <0.001 sig |
| SECONDARY Quality of Life |
71; 77; 69; 79 | 0.004 sig |
| SECONDARY Body Composition |
45; 42; 47; 40; 52; 50 | <0.001 sig |
| SECONDARY Thigh Muscle Composition |
155; 143; 164; 144; 120; 115 | <0.001 sig |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00959660). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.