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Exercise Effect on Aerobic Capacity and QOL in Heart Failure

US Department of Veterans Affairs (VA) logo

US Department of Veterans Affairs (VA)

Status and phase

Completed
Phase 4

Conditions

Heart Failure, Congestive

Treatments

Behavioral: Exercise

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00013221
NRI 95-213

Details and patient eligibility

About

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.

Full description

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.

Enrollment

84 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Left ventricular ejection fraction less than or equal to 40%. Stable heart failure.

Exclusion Criteria:

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

84 participants in 1 patient group

Arm 1
Other group
Treatment:
Behavioral: Exercise

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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