ArthritisPhase 2AFEP+10 KeysNCT01616433
Arthritis Foundation Exercise Program & "10 Keys" to Healthy Aging--Prevention Research Center
A Phase 2 study testing AFEP and "10 Keys" to Healthy Aging in people with Arthritis and Diabetes, run by University of Pittsburgh at 1 site in United States.
Trial summary
Older adults are at high risk for loss of independence because of age-related chronic health conditions. Of these chronic conditions, arthritis accounts for the largest proportion of the disability in the community. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Diabetes, Hypertension
- What is being tested?
- AFEP and "10 Keys" to Healthy Aging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 462 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Oct 2014
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50+ years old
- Attends at last one exercise class in a 10 week program
Who cannot join
- On oxygen
- Hospitalized for cardiac event in past 6 months (at least 1 overnight)
- Had major surgery in past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Community sites
Allegheny County Primarily, Pennsylvania
About this study
Official title: Arthritis Foundation Exercise Program & "10 Keys" to Healthy Aging
Older adults are at high risk for loss of independence because of age-related chronic health conditions. Of these chronic conditions, arthritis accounts for the largest proportion of the disability in the community. The investigators propose to target older adults who have self-reported arthritis or joint pain for dissemination of a disability prevention program. The program will be a collaborative effort of the Arthritis Foundation, the investigators Prevention Research Center staff and other key partners in the community. The project will develop information needed to provide guidance for implementation of the investigators intervention by other agencies and organizations. As a major thrust of the investigators CDC Prevention Research Center, the investigators have developed a comprehensive program focused on preventing disease and disability in older adults: the "10 Keys to Healthy Aging". Each of the 10 Keys disseminates proven approaches and current recommendations for prevention in older adults, focusing on age 65+ but also addressing age 50-65 years. The overall objective is to determine if an integrated evidence based exercise intervention (AFEP) combined with health education on preventive practices for older adults ("10 Keys") is more effective for improving mobility and risk factors for mobility disability and use of preventive services compared to exercise alone (AFEP). The investigators will also propose to evaluate the impact of geographic location on outcomes and overall sustainability of the program.
- Conditions
- Arthritis, Diabetes, Hypertension, Preventive Behaviors
- Being tested
- AFEP, "10 Keys" to Healthy Aging
- Keywords
- Arthritis, Preventive Behaviors
- Medical subject headings
- Arthritis, Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFEPBehavioural
Also called Arthritis Foundation Exercise Program (10 weeks, twice a week, 60 minutes per session)
Arthritis Foundation Exercise Program (10 weeks, twice a week, 60 minutes per session)
"10 Keys" to Healthy AgingBehavioural
"10 Keys" to Healthy Aging. 10 week program, twice a week, 75 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| Arthritis Foundation Exercise Program | Active comparator | Not described Receives: Behavioral: AFEP |
| AFEP + 10 Keys to Healthy Aging | Experimental | Arthritis Foundation Exercise Program integrated with the "10 Keys" to Healthy Aging Receives: Behavioral: "10 Keys" to Healthy Aging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preventive Behaviors
Measuring preventive behaviors emphasized by the "10 Keys" to Healthy Aging, such as cancer screenings, controlling blood pressure, immunizations, etc.
Measured: 1 year
Joint Pain & Stiffness
Self-reported joint pain and stiffness, as measured by the WOMAC.
Measured: 1 year
Cholesterol (LDL)
LDL cholesterol
Measured: 1 year
Glucose
Fasting glucose
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616433
- Sponsor's protocol ID
- IU48DP09-0014918-01
- Acronym
- AFEP+10 Keys
- Status last verified
- Dec 2014
- First submitted
- 7 Jun 2012
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthritis Foundation Exercise Program & "10 Keys" to Healthy Aging
- ClinicalTrials.gov ID
- NCT01616433
- Acronym / sponsor ID
- AFEP+10 Keys / IU48DP09-0014918-01
- Conditions
- Arthritis, Diabetes, Hypertension, Preventive Behaviors
- Keywords
- Arthritis, Preventive Behaviors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Arthritis Foundation
- Study start
- Mar 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 11 Jun 2012 (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.
Older adults are at high risk for loss of independence because of age-related chronic health conditions. Of these chronic conditions, arthritis accounts for the largest proportion of the disability in the community. The investigators propose to target older adults who have self-reported arthritis or joint pain for dissemination of a disability prevention program. The program will be a collaborative effort of the Arthritis Foundation, the investigators Prevention Research Center staff and other key partners in the community. The project will develop information needed to provide guidance for implementation of the investigators intervention by other agencies and organizations. As a major thrust of the investigators CDC Prevention Research Center, the investigators have developed a comprehensive program focused on preventing disease and disability in older adults: the "10 Keys to Healthy Aging". Each of the 10 Keys disseminates proven approaches and current recommendations for prevention in older adults, focusing on age 65+ but also addressing age 50-65 years. The overall objective is to determine if an integrated evidence based exercise intervention (AFEP) combined with health education on preventive practices for older adults ("10 Keys") is more effective for improving mobility and risk factors for mobility disability and use of preventive services compared to exercise alone (AFEP). The investigators will also propose to evaluate the impact of geographic location on outcomes and overall sustainability of the program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthritis Foundation Exercise Program | Active comparator | Behavioral: AFEP |
| AFEP + 10 Keys to Healthy Aging | Experimental | Behavioral: "10 Keys" to Healthy AgingArthritis Foundation Exercise Program integrated with the "10 Keys" to Healthy Aging |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 50+ years old
- Attends at last one exercise class in a 10 week program
Key exclusion criteria (3 listed)
- On oxygen
- Hospitalized for cardiac event in past 6 months (at least 1 overnight)
- Had major surgery in past 6 months
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 |
|---|---|---|
| AFEPAlso: Arthritis Foundation Exercise Program (10 weeks, twice a week, 60 minutes per session)Arthritis Foundation Exercise Program (10 weeks, twice a week, 60 minutes per session) | Behavioural | Arthritis Foundation Exercise Program |
| "10 Keys" to Healthy Aging"10 Keys" to Healthy Aging. 10 week program, twice a week, 75 minutes per session. | Behavioural | AFEP + 10 Keys to Healthy Aging |
Primary outcome
Preventive Behaviors
Time frame: 1 year
Measuring preventive behaviors emphasized by the "10 Keys" to Healthy Aging, such as cancer screenings, controlling blood pressure, immunizations, etc.
Joint Pain & Stiffness
Time frame: 1 year
Self-reported joint pain and stiffness, as measured by the WOMAC.
Cholesterol (LDL)
Time frame: 1 year
LDL cholesterol
Glucose
Time frame: 1 year
Fasting glucose
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 18 Dec 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AFEP and "10 Keys" to Healthy Aging in people with Arthritis and Diabetes, run by University of Pittsburgh 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 2 inclusion and 3 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 18 Dec 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
Preventive Behaviors (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 18 Dec 2014.