Cardiovascular DiseasePhase 3NCT00018265
Fitness and Daily Function in Adults
A Phase 3 study testing Task specific endurance training and Tai Chi in people with Cardiovascular Disease, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to examine the impact of aerobic fitness on the ability of able and disabled older adults to perform daily functional activities. Subjects are tested in their oxygen use patterns as they perform a series of functional tasks (such as walking on stairs) and following a 24-week training… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Task specific endurance training and Tai Chi
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to Sep 2003
- Phase
- Phase 3
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Both healthy and self-reported mobility-impaired older adults
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105
About this study
Official title: Oxygen Kinetics, Mobility Task Performance, and Task Training in Older Adults
The purpose of this study is to examine the impact of aerobic fitness on the ability of able and disabled older adults to perform daily functional activities. Subjects are tested in their oxygen use patterns as they perform a series of functional tasks (such as walking on stairs) and following a 24-week training program focused on improving the ability to perform daily tasks likely requiring aerobic fitness (such as walking on stairs).
- Conditions
- Cardiovascular Disease
- Being tested
- Task specific endurance training, Tai Chi
- Keywords
- Rehabilitation, exercise test, aging
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task specific endurance trainingBehavioural
Tai ChiBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2001 (estimated)
- Study startOct 1999
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 140 participants
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Donald Dengel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00018265
- Sponsor's protocol ID
- AGCG-003-99S
- Status last verified
- Dec 2004
- First submitted
- 3 Jul 2001
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Kinetics, Mobility Task Performance, and Task Training in Older Adults
- ClinicalTrials.gov ID
- NCT00018265
- Acronym / sponsor ID
- AGCG-003-99S
- Conditions
- Cardiovascular Disease
- Keywords
- Rehabilitation, exercise test, aging
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 1999
- Study completion
- Sep 2003
- First posted
- 5 Jul 2001 (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 purpose of this study is to examine the impact of aerobic fitness on the ability of able and disabled older adults to perform daily functional activities. Subjects are tested in their oxygen use patterns as they perform a series of functional tasks (such as walking on stairs) and following a 24-week training program focused on improving the ability to perform daily tasks likely requiring aerobic fitness (such as walking on stairs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
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 |
|---|---|---|
| Task specific endurance training | Behavioural | – |
| Tai Chi | Behavioural | – |
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 21 Jan 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.
Donald Dengel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Task specific endurance training and Tai Chi in people with Cardiovascular Disease, 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?
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 21 Jan 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 21 Jan 2009.