Functional Circuit Training in Older Adults With Congestive Heart Failure

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108147
First received: April 14, 2005
Last updated: March 4, 2009
Last verified: March 2009

April 14, 2005
March 4, 2009
October 2003
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Complete list of historical versions of study NCT00108147 on ClinicalTrials.gov Archive Site
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Functional Circuit Training in Older Adults With Congestive Heart Failure
Functional Circuit Training in Older Adults With Congestive Heart Failure

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.

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).

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Heart Failure, Congestive
  • Procedure: Circuit Training
  • Procedure: Cardiac Rehabilitation
  • Procedure: Flexibility and toning
  • Experimental: 1
    Circuit Training
    Intervention: Procedure: Circuit Training
  • Active Comparator: 2
    Cardiac Rehabilitation
    Intervention: Procedure: Cardiac Rehabilitation
  • Active Comparator: 3
    Flexibility and toning
    Intervention: Procedure: Flexibility and toning
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria:

  • Congestive Heart Failure

Exclusion Criteria:

Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00108147
AGCG-002-03S
Not Provided
Alexander, Neil - Principal Investigator, Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Neil Alexander, MD VA Ann Arbor Healthcare System
Department of Veterans Affairs
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP