Cardiovascular DiseasesNCT00142675
Using Peers to Promote Exercise in Older Adults
A study testing Physical Activity in people with Cardiovascular Diseases, run by Stanford University.
Trial summary
A randomized controlled trial to evaluate the effects of a 12-month telephone-supervised, home-based physical activity intervention, delivered via health educators versus supervised, trained peers, on physical activity patterns. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Feb 2003to Jan 2007
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Women and men ages 50 years and above of the San Francisco Bay area who are free of any medical condition or disorder that would limit participation in moderate intensity exercise, not hypertensive, stable on all medications, possess English-speaking and reading skills, and are available and able to participate in the evaluations and intervention.
About this study
A randomized controlled trial to evaluate the effects of a 12-month telephone-supervised, home-based physical activity intervention, delivered via health educators versus supervised, trained peers, on physical activity patterns. Inactive men and women ages 50 years and older will be randomly assigned to one of these two programs or to an attention-control arm.
Read the detailed description
BACKGROUND:
Despite the recognized benefits of regular physical activity, older adults remain among the most inactive segments of the U.S. population. A number of studies have demonstrated the health impact and resultant reduction in chronic disease risk achieved by improving physical activity patterns. Effective telephone-based counseling approaches for promoting and sustaining regular physical activity among older adults have been developed and validated. Such mediated interventions provide a level of individual tailoring and ongoing support to long-term adherence, while allowing for ongoing program delivery that is more flexible, convenient, and potentially lower-cost than face-to face program delivery formats. Telephone-based delivery format also allows for potentially greater reach into segments of the older population that may find it difficult or unappealing to come to community settings on a regular basis.
DESIGN NARRATIVE:
A 12-month randomized trial in which women and men ages 50 years and above living in the San Francisco Bay area who meet medical and physical activity criteria, following a baseline evaluation, be randomized to one of three study arms: telephone-supervised, home-based physical activity instruction via a trained health educator; telephone-supervised, home-based physical activity instruction via a supervised peer facilitator; or an attention-control arm consisting of health educator-based telephone delivery of non-physical activity oriented health information and support. All subjects will have a follow-up evaluation at 6 and 12 months.
- Conditions
- Cardiovascular Diseases
- Being tested
- Physical Activity
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startFeb 2003
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142675
- Sponsor's protocol ID
- 254
- Other IDs
- R01HL072489
- Status last verified
- Mar 2014
- First submitted
- 1 Sep 2005
- Last updated
- 5 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Peers to Promote Exercise in Older Adults
- ClinicalTrials.gov ID
- NCT00142675
- Acronym / sponsor ID
- 254
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2003
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 2 Sep 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.
A randomized controlled trial to evaluate the effects of a 12-month telephone-supervised, home-based physical activity intervention, delivered via health educators versus supervised, trained peers, on physical activity patterns. Inactive men and women ages 50 years and older will be randomly assigned to one of these two programs or to an attention-control arm.
Detailed description
BACKGROUND:
Despite the recognized benefits of regular physical activity, older adults remain among the most inactive segments of the U.S. population. A number of studies have demonstrated the health impact and resultant reduction in chronic disease risk achieved by improving physical activity patterns. Effective telephone-based counseling approaches for promoting and sustaining regular physical activity among older adults have been developed and validated. Such mediated interventions provide a level of individual tailoring and ongoing support to long-term adherence, while allowing for ongoing program delivery that is more flexible, convenient, and potentially lower-cost than face-to face program delivery formats. Telephone-based delivery format also allows for potentially greater reach into segments of the older population that may find it difficult or unappealing to come to community settings on a regular basis.
DESIGN NARRATIVE:
A 12-month randomized trial in which women and men ages 50 years and above living in the San Francisco Bay area who meet medical and physical activity criteria, following a baseline evaluation, be randomized to one of three study arms: telephone-supervised, home-based physical activity instruction via a trained health educator; telephone-supervised, home-based physical activity instruction via a supervised peer facilitator; or an attention-control arm consisting of health educator-based telephone delivery of non-physical activity oriented health information and support. All subjects will have a follow-up evaluation at 6 and 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, 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 |
|---|---|---|
| Physical Activity | 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 5 Mar 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Cardiovascular Diseases, run by Stanford University.
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 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
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 5 Mar 2014.