We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Home Walking Exercise Training in Advanced Heart Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00012883
First Posted: March 16, 2001
Last Update Posted: April 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose

Heart failure is a major public health burden in the United States characterized by increased morbidity and mortality, and reduce exercise capacity with distressing symptoms of dyspnea and fatigue. Evaluating the effects of complementary intervention (such as exercise training) on functional status and QOL are clinically important and relevant to HF patients.

In the last decade, hospital-based and a home bicycle exercise programs for HF have been shown to improve peak oxygen consumption (VO2) and symptom scores, and restore autonomic balance. These programs may be costly for patients to perform. Improved peak VO2 may not necessarily translate into improved functional status and quality of life. To date, the effects of a home walking exercise program alone on functional status, QOL and autonomic tone has not been evaluated.


Condition Intervention
Heart Failure Functional Status Quality of Life Behavioral: Homewalking exercise program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Home Walking Exercise Training in Advanced Heart Failure

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Estimated Enrollment: 110
Study Completion Date: December 2001
Arms Assigned Interventions
Arm 1
Homewalking Exercise Program
Behavioral: Homewalking exercise program

Detailed Description:

Background:

Heart failure is a major public health burden in the United States characterized by increased morbidity and mortality, and reduce exercise capacity with distressing symptoms of dyspnea and fatigue. Evaluating the effects of complementary intervention (such as exercise training) on functional status and QOL are clinically important and relevant to HF patients.

In the last decade, hospital-based and a home bicycle exercise programs for HF have been shown to improve peak oxygen consumption (VO2) and symptom scores, and restore autonomic balance. These programs may be costly for patients to perform. Improved peak VO2 may not necessarily translate into improved functional status and quality of life. To date, the effects of a home walking exercise program alone on functional status, QOL and autonomic tone has not been evaluated.

Objectives:

The specific aim was to compare functional status (FS), quality of life (QOL) and autonomic tone in 2 groups of advanced HF patients (nurse-managed home walking exercise (HWE) group vs. control group).

Methods:

A randomized controlled trial comparing a 12-week nurse-managed progressive HWE protocol to usual activity was conducted in 79 HF patients (78[99%] male; mean age 62.6 � 10.6 years; EF 27 � 8.8%; 63 [80%] NYHA II, 15[20%] NYHA III-IV; HF duration 39.2 � 41.8 months) from a VA medical center and a university affiliated medical center. The 12- week HWE program is once a day, 5x a week and initiated at 10 minutes and progressively increases in duration and intensity up to 60 minutes. Pre- and post-study measures were FS (peak VO2 and ventilatory threshold via CPX, 6-minute walk test (6MWT) and a Heart Failure Functional Status Inventory (HFFSI)), QOL (Cardiac Quality of life Index (C-QLI), SF-36, and Dyspnea-Fatigue Index (DFI) with global rating of symptoms), and autonomic tone (norepinephrine (NE) and heart rate variability (HRV)). Intention-to-treat analysis with repeated measures ANOVA was used to identify group differences.

Status:

Completed.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Should have a stable heart failure in the past 3 months (Max Age is 80)

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00012883


Locations
United States, California
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Teresita E. Corvera-Tindel, PhD RN MN VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00012883     History of Changes
Other Study ID Numbers: NRI 96-031
First Submitted: March 14, 2001
First Posted: March 16, 2001
Last Update Posted: April 7, 2015
Last Verified: February 2007

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases