Heart Failure, Congestive Clinical Trial
Official title:
Exercise Effect on Aerobic Capacity and QOL in Heart Failure
Chronic heart failure (HF) is a syndrome of impaired ventricular function resulting in clinical symptoms of fatigue, dyspnea, and decreased exercise capacity. These symptoms lead to a cyclical pattern of an increasing sedentary lifestyle with accompanying deconditioning and deterioration of muscle function. Until recently, the prescription for individuals with HF was rest and minimization of physical exertion.
Background:
Chronic heart failure (HF) is a syndrome of impaired ventricular function resulting in
clinical symptoms of fatigue, dyspnea, and decreased exercise capacity. These symptoms lead
to a cyclical pattern of an increasing sedentary lifestyle with accompanying deconditioning
and deterioration of muscle function. Until recently, the prescription for individuals with
HF was rest and minimization of physical exertion.
Objectives:
The primary objectives of this randomized clinical trial were to determine whether subjects,
with moderate to severe chronic HF, who completed a 12-week individualized program of
cardiopulmonary training (exercise group) would have significantly greater (i) quality of
life, measured by the Rand Short Form-36, and (ii) aerobic fitness, measured by oxygen
uptake during symptom limited maximal metabolic treadmill testing, than subjects who met
weekly with an investigator and received vital sign measurements (non-exercise group).
Methods:
A randomized controlled clinical trial was utilized. Individuals who met the inclusion
criteria were randomly assigned to either an exercise or control group. Individuals in the
exercise group received 36 weeks of exercise training (primary outcome variables were
measured at 12 weeks). Participants in the control group received weekly visits with a nurse
for 12 weeks.
Status:
Ongoing data analysis for publication. Final report submitted.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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