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Heart Failure, CongestiveNCT00108147

Functional Circuit Training in Older Adults With Congestive Heart Failure

A study testing Circuit Training, Cardiac Rehabilitation and Flexibility and toning in people with Heart Failure, Congestive, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Heart Failure, Congestive
What is being tested?
Circuit Training, Cardiac Rehabilitation and Flexibility and toning
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
Not given
Where
1 siteUnited States
Study dates
Oct 2003to not given
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Congestive Heart Failure

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Ann Arbor Healthcare System

    Ann Arbor, Michigan, 48113

Other trials in United States

About this study

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.

Read the 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).

Being tested
Circuit Training, Cardiac Rehabilitation, Flexibility and toning
Keywords
Aged, Congestive Heart Failure, Exercise
Medical subject headings
Heart Failure, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Circuit TrainingProcedure or surgery

  • Cardiac RehabilitationProcedure or surgery

  • Flexibility and toningProcedure or surgery

Study groups in NCT00108147
Study groupRoleWhat they receive
1ExperimentalCircuit Training
Receives: Procedure: Circuit Training
2Active comparatorCardiac Rehabilitation
Receives: Procedure: Cardiac Rehabilitation
3Active comparatorFlexibility and toning
Receives: Procedure: Flexibility and toning

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2005 (estimated)
  2. Study startOct 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
IDs, dates and publications
ClinicalTrials.gov ID
NCT00108147
Sponsor's protocol ID
AGCG-002-03S
Status last verified
Mar 2009
First submitted
14 Apr 2005
Last updated
6 Mar 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Circuit Training, Cardiac Rehabilitation and Flexibility and toning in people with Heart Failure, Congestive, run by US Department of Veterans Affairs at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2009.

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