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.
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
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:
- 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.
- 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.
- Reassess all groups after an additional 12 weeks in the measures identified above to identify how well the three groups maintain their function.
- 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).
- Conditions
- Heart Failure, Congestive
- 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 group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Circuit Training Receives: Procedure: Circuit Training |
| 2 | Active comparator | Cardiac Rehabilitation Receives: Procedure: Cardiac Rehabilitation |
| 3 | Active comparator | Flexibility 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.
- First posted15 Apr 2005 (estimated)
- Study startOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Neil Alexander, MD, Principal investigator, VA Ann Arbor Healthcare System
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Circuit Training in Older Adults With Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00108147
- Acronym / sponsor ID
- AGCG-002-03S
- Conditions
- Heart Failure, Congestive
- Keywords
- Aged, Congestive Heart Failure, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2003
- First posted
- 15 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In older (65 years of age or older) patients with congestive heart failure, we propose to:
- 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.
- 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.
- Reassess all groups after an additional 12 weeks in the measures identified above to identify how well the three groups maintain their function.
- 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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Circuit TrainingCircuit Training |
| 2 | Active comparator | Procedure: Cardiac RehabilitationCardiac Rehabilitation |
| 3 | Active comparator | Procedure: Flexibility and toningFlexibility and toning |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Congestive Heart Failure
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circuit Training | Procedure or surgery | 1 |
| Cardiac Rehabilitation | Procedure or surgery | 2 |
| Flexibility and toning | Procedure or surgery | 3 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Alexander, MD principal investigator
VA Ann Arbor Healthcare System
1 site in 1 country: see every site and its status.
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.