N/A N=100 Randomized Single-blind Treatment

Exercise Intolerance in Elderly Patients With Diastolic Heart Failure

Heart Failure, Diastolic · Obesity

Bottom Line

View on ClinicalTrials.gov: NCT00959660 ↗

Enrolled (actual)

100

Serious AEs

3.0%

Results posted

Apr 2018

Primary outcome: Primary: Exercise Capacity — 15.5; 15.5; 14.1; 16.6 ml/kg/min — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Exercise (Behavioral); Dietary Intervention (Dietary_supplement); Diet and exercise (Behavioral); Attention Control (Other)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: Wake Forest University
Primary completion: Aug 2012

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

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.

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

View full record on ClinicalTrials.gov →

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.