Functional Circuit Training in Older Adults With Congestive Heart Failure

March 4, 2009 updated by: US Department of Veterans Affairs
The goal of this study is to determine the effect of a functional circuit training program as compared to standard cardiac rehabilitation or control exercise in improving physical function and activity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In older (65 years of age or older) patients with congestive heart failure, we propose to:

  1. Assess: a) Peak aerobic capacity (peak VO2) during a monitored, standardized treadmill test; b) Oxygen uptake kinetics and heart rate during a standardized submaximal treadmill test; c) Performance on a set of functional mobility tasks; d) Self-report of physical disability and difficulty in performing daily tasks, and physical activity.
  2. Conduct a 12-week randomized controlled trial, comparing changes in these assessed measures in patients randomized to three different groups: 1) standard cardiac rehabilitation using bicycle exercise; 2) group functional circuit training focusing on exercises that involve functional mobility tasks and a home-activities exercise component; 3) a chair-based, flexibility and "toning " (low level resistance) group control exercise.
  3. Reassess all groups after an additional 12 weeks in the measures identified above to identify how well the three groups maintain their function.
  4. Examine the mechanisms underlying change in functional mobility performance and self-reported function as a result of the interventions

Primary hypothesis 1: Compared to chair-based exercise controls at the end of week 12, both the cardiac rehabilitation and functional circuit training groups will show improvements in measures of peak aerobic capacity, submaximal oxygen uptake kinetics, functional mobility performance, and self-reported function.

Primary hypothesis 2: Compared to the other two groups that are given exercise instructions only, the functional circuit training group, who continue their home activities exercise program, show less decline by week 24 in measures of peak aerobic capacity, submaximal oxygen uptake kinetics, functional mobility performance, and self-reported function.

Secondary hypothesis: Measures of submaximal oxygen uptake kinetics are better predictors of changes in functional mobility performance and self-reported function than peak aerobic capacity, muscle strength, joint range of motion, balance, and behavioral factors (such as depression).

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48113
        • VA Ann Arbor Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Congestive Heart Failure

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Circuit Training
Procedure: Circuit Training
Active Comparator: 2
Cardiac Rehabilitation
Procedure: Cardiac Rehabilitation
Active Comparator: 3
Flexibility and toning
Procedure: Flexibility and toning

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Neil Alexander, MD, VA Ann Arbor Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Study Registration Dates

First Submitted

April 14, 2005

First Submitted That Met QC Criteria

April 14, 2005

First Posted (Estimate)

April 15, 2005

Study Record Updates

Last Update Posted (Estimate)

March 6, 2009

Last Update Submitted That Met QC Criteria

March 4, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGCG-002-03S

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe