OsteoarthritisNCT00421681
Exercise Adherence Among Older Adults With Osteoarthritis
A study testing Fit and Strong! Exercise Program in people with Osteoarthritis, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
The purpose of this study is to assess the comparative effects of two different ways of enhancing long-term adherence to and benefits associated with participation in the evidence-based, Fit and Strong multi-component exercise intervention for older persons with lower extremity osteoarthritis. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Fit and Strong! Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Sep 2008
- 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
- 60 years of age or older
- Presence of osteoarthritis in the lower extremities (including hip, knee, ankle, feet and lower back) with an American College of Rheumatology functional class rating of I, II, or III
- No other contraindication from a personal physician for participation in fitness walking or low-impact aerobics and strength training
- Lack of moderate to severe cognitive impairment shown as assessed by the Short Portable Mental Status Questionnaire
Who cannot join
- Under 60 years of age
- Lack of osteoarthritis in the lower extremities
- Contraindication from a personal physician for participation in activities described above
- Presence of moderate to severe cognitive impairment as assessed by the Short Portable Mental Status Questionnaire
- Steroid injections in either knee or hip within previous six months
- Knee or hip surgery within previous six months
Show all 11Show fewer
- Plans for total knee or hip replacement within the next year
- Rheumatoid arthritis or other system inflammatory arthritis
- Diabetes that is not under good control
- Current participation in a structured aerobic exercise program
- Participation in original trial of the Fit and Strong Program
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Research on Health and Aging
Chicago, Illinois, 60608
About this study
The purpose of this study is to assess the comparative effects of two different ways of enhancing long-term adherence to and benefits associated with participation in the evidence-based, Fit and Strong multi-component exercise intervention for older persons with lower extremity osteoarthritis.
Read the detailed description
Osteoarthritis (OA) is the most common condition affecting older people today. It is the leading cause of disability among older people and its impact is projected to increase substantially with the aging of the U.S population from 43 million currently to 60 million by 2020.
Promising 2- and 6-month outcomes have recently been reported from a randomized trial of a multi-component exercise intervention targeted at older adults with lower extremity OA. The Fit and Strong intervention, developed and tested as part of the Midwest Roybal Center for Health Maintenance, coupled strength training and aerobic walking with health education for sustained behavior change. Improvements have been found in confidence in ability to exercise, confidence in ability to continue exercising over time, lower extremity stiffness, lower extremity pain, and 6-minute distance walk. Importantly, the average adherence rate in the people who participated in the exercise intervention at six months was twice that reported by controls.
The specific aims of this study are to use a multi-site randomized controlled clinical trial to replicate the Fit and Strong intervention and to test the comparative effectiveness of a negotiated/tailored follow-up maintenance strategy vs. a mainstreaming, facility-based maintenance strategy, both of which will be tested with and without telephone reinforcement as an enhancement.
All enrolled participants will participate in the 8-week Fit and Strong exercise program designed specifically for older adults with lower-extremity OA. Prior to the conclusion of Fit and Strong participants will be randomly assigned to one of two follow-up maintenance groups. There is no more than minimal risk associated with this program.
- Conditions
- Osteoarthritis
- Being tested
- Fit and Strong! Exercise Program
- Keywords
- Aging, exercise, health behavior
- Medical subject headings
- Osteoarthritis, Motor Activity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit and Strong! Exercise ProgramBehavioural
Fit and Strong! is an 8-week (24 sessions) multi-component exercise and health education intervention, including flexibility, aerobic conditioning, strength training, and group discussion/problem solving for lifestyle change. Following participation in Fit and Strong!, all study participants are randomly assigned to one of 2 maintenance treatment follow-up groups.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Treatment Arm A will develop tailored/negotiated contracts with the exercise instructor to maintain post intervention exercise adherence at home or in the community. Half of the participants in this "negotiated maintenance" arm will be randomly assigned to receive telephone calls to reinforce adherence and half will be assigned to a no telephone calls group. Receives: Behavioral: Fit and Strong! Exercise Program |
| B | Experimental | Treatment Arm B will be mainstreamed into an ongoing facility-based exercise program for post intervention exercise adherence. Persons in this "mainstream follow up" arm will be randomly assigned such that half will receive regular telephone reinforcement follow up and half will not. Receives: Behavioral: Fit and Strong! Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of exercise behavior measured by CHAMPS (Community Healthy Activities Model Program For Seniors)
Measured: Baseline, 2 months, 6 months, 12 months, 18 months
Secondary outcomes (4)
Changes in lower extremity strength (timed sit-stand test)
Measured: Baseline, 2 months, 6 months, 12 months, 18 months
Aerobic capacity (6 minute distance walk)
Measured: Baseline, 2 months, 6 months, 12 months, 18 months
Pain, stiffness, physical function subscales measured by WOMAC (Western Ontario and McMaster osteoarthritis index)
Measured: Baseline, 2 months, 6 months, 12 months, 18 months
Functional ability measured by GeriAIMS (Geriatric Arthritis Impact Measurement Scale)
Measured: Baseline, 2 months, 6 months, 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2007 (estimated)
- Study startOct 2003
- Primary completionSep 2008 (estimated)
- Study completionSep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Susan Hughes, DSW, Principal investigator, Center for Research on Health and Aging , University of Illinois, Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421681
- Sponsor's protocol ID
- AG0075
- Other IDs
- 5R01AG023424
- Status last verified
- Jan 2008
- First submitted
- 10 Jan 2007
- Last updated
- 14 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Hughes SL, Seymour RB, Campbell R, Pollak N, Huber G, Sharma L. Impact of the fit and strong intervention on older adults with osteoarthritis. Gerontologist. 2004 Apr;44(2):217-28. doi: 10.1093/geront/44.2.217.
PubMed 15075418Hughes SL, Seymour RB, Campbell RT, Huber G, Pollak N, Sharma L, Desai P. Long-term impact of Fit and Strong! on older adults with osteoarthritis. Gerontologist. 2006 Dec;46(6):801-14. doi: 10.1093/geront/46.6.801.
PubMed 17169935Seymour RB, Hughes SL, Campbell RT, Huber GM, Desai P. Comparison of two methods of conducting the Fit and Strong! program. Arthritis Rheum. 2009 Jul 15;61(7):876-84. doi: 10.1002/art.24517.
PubMed 19565560
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Adherence Among Older Adults With Osteoarthritis
- ClinicalTrials.gov ID
- NCT00421681
- Acronym / sponsor ID
- AG0075
- Conditions
- Osteoarthritis
- Keywords
- Aging, exercise, health behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Oct 2003
- Primary completion
- Sep 2008 (estimated)
- Study completion
- Sep 2008 (estimated)
- First posted
- 12 Jan 2007 (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 assess the comparative effects of two different ways of enhancing long-term adherence to and benefits associated with participation in the evidence-based, Fit and Strong multi-component exercise intervention for older persons with lower extremity osteoarthritis.
Detailed description
Osteoarthritis (OA) is the most common condition affecting older people today. It is the leading cause of disability among older people and its impact is projected to increase substantially with the aging of the U.S population from 43 million currently to 60 million by 2020.
Promising 2- and 6-month outcomes have recently been reported from a randomized trial of a multi-component exercise intervention targeted at older adults with lower extremity OA. The Fit and Strong intervention, developed and tested as part of the Midwest Roybal Center for Health Maintenance, coupled strength training and aerobic walking with health education for sustained behavior change. Improvements have been found in confidence in ability to exercise, confidence in ability to continue exercising over time, lower extremity stiffness, lower extremity pain, and 6-minute distance walk. Importantly, the average adherence rate in the people who participated in the exercise intervention at six months was twice that reported by controls.
The specific aims of this study are to use a multi-site randomized controlled clinical trial to replicate the Fit and Strong intervention and to test the comparative effectiveness of a negotiated/tailored follow-up maintenance strategy vs. a mainstreaming, facility-based maintenance strategy, both of which will be tested with and without telephone reinforcement as an enhancement.
All enrolled participants will participate in the 8-week Fit and Strong exercise program designed specifically for older adults with lower-extremity OA. Prior to the conclusion of Fit and Strong participants will be randomly assigned to one of two follow-up maintenance groups. There is no more than minimal risk associated with this program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Fit and Strong! Exercise ProgramTreatment Arm A will develop tailored/negotiated contracts with the exercise instructor to maintain post intervention exercise adherence at home or in the community. Half of the participants in this "negotiated maintenance" arm will be randomly assigned to receive telephone calls to reinforce adherence and half will be assigned to a no telephone calls group. |
| B | Experimental | Behavioral: Fit and Strong! Exercise ProgramTreatment Arm B will be mainstreamed into an ongoing facility-based exercise program for post intervention exercise adherence. Persons in this "mainstream follow up" arm will be randomly assigned such that half will receive regular telephone reinforcement follow up and half will not. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 60 years of age or older
- Presence of osteoarthritis in the lower extremities (including hip, knee, ankle, feet and lower back) with an American College of Rheumatology functional class rating of I, II, or III
- No other contraindication from a personal physician for participation in fitness walking or low-impact aerobics and strength training
- Lack of moderate to severe cognitive impairment shown as assessed by the Short Portable Mental Status Questionnaire
Key exclusion criteria (11 listed)
- Under 60 years of age
- Lack of osteoarthritis in the lower extremities
- Contraindication from a personal physician for participation in activities described above
- Presence of moderate to severe cognitive impairment as assessed by the Short Portable Mental Status Questionnaire
- Steroid injections in either knee or hip within previous six 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 |
|---|---|---|
| Fit and Strong! Exercise ProgramFit and Strong! is an 8-week (24 sessions) multi-component exercise and health education intervention, including flexibility, aerobic conditioning, strength training, and group discussion/problem solving for lifestyle change. Following participation in Fit and Strong!, all study participants are randomly assigned to one of 2 maintenance treatment follow-up groups. | Behavioural | A, B |
Primary outcome
Maintenance of exercise behavior measured by CHAMPS (Community Healthy Activities Model Program For Seniors)
Time frame: Baseline, 2 months, 6 months, 12 months, 18 months
4 secondary outcomes
Changes in lower extremity strength (timed sit-stand test)
Time frame: Baseline, 2 months, 6 months, 12 months, 18 months
Aerobic capacity (6 minute distance walk)
Time frame: Baseline, 2 months, 6 months, 12 months, 18 months
Pain, stiffness, physical function subscales measured by WOMAC (Western Ontario and McMaster osteoarthritis index)
Time frame: Baseline, 2 months, 6 months, 12 months, 18 months
Functional ability measured by GeriAIMS (Geriatric Arthritis Impact Measurement Scale)
Time frame: Baseline, 2 months, 6 months, 12 months, 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2009.
- Background: PubMed 15075418Hughes SL, Seymour RB, Campbell R, Pollak N, Huber G, Sharma L. Impact of the fit and strong intervention on older adults with osteoarthritis. Gerontologist. 2004 Apr;44(2):217-28. doi: 10.1093/geront/44.2.217.
- Background: PubMed 17169935Hughes SL, Seymour RB, Campbell RT, Huber G, Pollak N, Sharma L, Desai P. Long-term impact of Fit and Strong! on older adults with osteoarthritis. Gerontologist. 2006 Dec;46(6):801-14. doi: 10.1093/geront/46.6.801.
- Derived from this study: PubMed 19565560Seymour RB, Hughes SL, Campbell RT, Huber GM, Desai P. Comparison of two methods of conducting the Fit and Strong! program. Arthritis Rheum. 2009 Jul 15;61(7):876-84. doi: 10.1002/art.24517.
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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.
Susan Hughes, DSW principal investigator
Center for Research on Health and Aging , University of Illinois, Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fit and Strong! Exercise Program in people with Osteoarthritis, run by National Institute on Aging (NIA) 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 14 Dec 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?
Results are not available in the source record.
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?
Maintenance of exercise behavior measured by CHAMPS (Community Healthy Activities Model Program For Seniors) (time frame: Baseline, 2 months, 6 months, 12 months, 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00421681, which also lists 3 linked publications.
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 14 Dec 2009.