Exercise Effect on Aerobic Capacity and QOL in Heart Failure
Primary Purpose
Heart Failure, Congestive
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Congestive
Eligibility Criteria
Inclusion Criteria: Left ventricular ejection fraction less than or equal to 40%. Stable heart failure. Exclusion Criteria:
Sites / Locations
- Edward Hines Jr. VA Hospital, Hines, IL
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00013221
First Posted
March 14, 2001
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00013221
Brief Title
Exercise Effect on Aerobic Capacity and QOL in Heart Failure
Official Title
Exercise Effect on Aerobic Capacity and QOL in Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2000 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Exercise
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Left ventricular ejection fraction less than or equal to 40%. Stable heart failure.
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eileen G. Collins, PhD RN
Organizational Affiliation
Edward Hines Jr. VA Hospital, Hines, IL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Walter Edwin Langbein, PhD
Organizational Affiliation
Edward Hines Jr. VA Hospital, Hines, IL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edward Hines Jr. VA Hospital, Hines, IL
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141-5000
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15136775
Citation
Collins E, Langbein WE, Dilan-Koetje J, Bammert C, Hanson K, Reda D, Edwards L. Effects of exercise training on aerobic capacity and quality of life in individuals with heart failure. Heart Lung. 2004 May-Jun;33(3):154-61. doi: 10.1016/j.hrtlng.2003.12.009.
Results Reference
result
Learn more about this trial
Exercise Effect on Aerobic Capacity and QOL in Heart Failure
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