OsteoarthritisPhase 2NCT00000434
Impact of Exercise on Older Persons With Osteoarthritis
A Phase 2 study testing Fit and Strong! in people with Osteoarthritis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 2 sites in United States.
Trial summary
Previous studies have found that exercise can reduce pain, improve endurance for physical activities, and improve cardiovascular fitness over time. However, these studies have not looked at the impact of exercise programs for older adults with osteoarthritis or at how long older adults continue exercising after a… 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!
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 1983to Sep 2003
- 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 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 of the lower extremities with an American College of Rheumatology functional class rating of I, II, or III
- No other contraindication from a personal physician for participation in the fitness walking
- Lack of moderate-to-severe cognitive impairment as assessed by the Short Portable Mental Status Questionnaire
Who cannot join
- Under 60 years of age
- Lack of osteoarthritis of the lower extremities
- Contraindication from a personal physician for participation in fitness walking
- Presence of moderate-to-severe cognitive impairment as assessed by the Short Portable Mental Status Questionnaire
- Steroid injections in either hip or knee within the previous 6 months
- Uncomplicated knee or hip surgery within previous year
Show all 11Show fewer
- Complicated knee or hip surgery within previous year
- Plans for total knee or hip replacement within the next year
- Rheumatoid arthritis or other systemic inflammatory arthritis
- Diabetes that is not under control
- Current participation in a structured aerobic exercise program
Trial locations and contacts
2 sites in 1 country.
United States2 sites
North Park Village
Chicago, Illinois, 60646
Bernard Horwich Jewish Community Center
Chicago, Illinois, 60659
About this study
Official title: Impact of Exercise on Older Persons With Osteoarthritis (OA)
Previous studies have found that exercise can reduce pain, improve endurance for physical activities, and improve cardiovascular fitness over time. However, these studies have not looked at the impact of exercise programs for older adults with osteoarthritis or at how long older adults continue exercising after a program is finished. This study will look at the long-term effects of a structured exercise program for people aged 60 or older who have osteoarthritis of the hip or knee. One goal of the exercise program is to encourage older people with osteoarthritis to continue exercising.
We will randomly assign study participants to either the exercise program or a control group that does not do the exercise program. We will monitor participants at the start of the study, at 8 weeks, and every 3 months for 2 years after the program is completed. The exercise program lasts for 8 weeks and includes an exercise part and an educational part led by trained physical therapists. We believe that participants in the treatment (exercise) group will show higher rates of continued exercise and higher functional status over time compared to the group of people who do not participate in the exercise program.
Read the detailed description
Recent exercise interventions have demonstrated statistically significant short-term improvements in muscle strength, fitness, and physical activity in people under the age of 70. This study seeks to determine if those same benefits can be achieved in an older population (mean age 84) with osteoarthritis of the hip or knee. The study will examine the long-term effects of a structured exercise program that seeks to promote adherence to continued exercise.
We will randomly assign people who meet the study criteria to the exercise intervention or control group. We will conduct measures at baseline, at 8 weeks, and at 3-month intervals for 2 years following the intervention. The exercise component of the intervention will include lower extremity muscle strengthening, range-of-motion exercises, and fitness walking. An educational component will focus on arthritis self-efficacy and perceived self-reported exercise efficacy. We hypothesize that treatment group participants will exhibit higher rates of adherence to exercise and higher functional status outcomes over time compared to controls.
- Conditions
- Osteoarthritis
- Being tested
- Fit and Strong!
- Keywords
- Osteoarthritis, Health education, Aerobic exercise, Self-efficacy, Muscle strength, Outcomes research, Longitudinal study
- Medical subject headings
- Osteoarthritis, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit and Strong!Behavioural
Fit and Strong! is a multi-component exercise and health education program that includes flexibility, aerobic conditioning, strength training, and group discussion/problem solving for lifestyle change.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fit and Strong! is a multi-component exercise and health education program that incorporates flexibility, aerobic conditioning, strength training, and group discussion/problem solving for lifestyle change. Receives: Behavioral: Fit and Strong! |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to exercise
Measured: 12 months
Secondary outcomes (1)
Pain and stiffness
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2000 (estimated)
- Study startDec 1983
- Primary completionSep 2003
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute on Aging (NIA)
- Investigators
- Susan Hughes, Principal investigator, Center for Research on Health and Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000434
- Sponsor's protocol ID
- P60AR030692
- Other IDs
- NIAMS-050
- Status last verified
- Dec 2007
- First submitted
- 21 Jan 2000
- Last updated
- 22 Aug 2019
- 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 17169935
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exercise on Older Persons With Osteoarthritis (OA)
- ClinicalTrials.gov ID
- NCT00000434
- Acronym / sponsor ID
- P60AR030692
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Health education, Aerobic exercise, Self-efficacy, Muscle strength, Outcomes research, Longitudinal study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Dec 1983
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 24 Jan 2000 (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.
Previous studies have found that exercise can reduce pain, improve endurance for physical activities, and improve cardiovascular fitness over time. However, these studies have not looked at the impact of exercise programs for older adults with osteoarthritis or at how long older adults continue exercising after a program is finished. This study will look at the long-term effects of a structured exercise program for people aged 60 or older who have osteoarthritis of the hip or knee. One goal of the exercise program is to encourage older people with osteoarthritis to continue exercising.
We will randomly assign study participants to either the exercise program or a control group that does not do the exercise program. We will monitor participants at the start of the study, at 8 weeks, and every 3 months for 2 years after the program is completed. The exercise program lasts for 8 weeks and includes an exercise part and an educational part led by trained physical therapists. We believe that participants in the treatment (exercise) group will show higher rates of continued exercise and higher functional status over time compared to the group of people who do not participate in the exercise program.
Detailed description
Recent exercise interventions have demonstrated statistically significant short-term improvements in muscle strength, fitness, and physical activity in people under the age of 70. This study seeks to determine if those same benefits can be achieved in an older population (mean age 84) with osteoarthritis of the hip or knee. The study will examine the long-term effects of a structured exercise program that seeks to promote adherence to continued exercise.
We will randomly assign people who meet the study criteria to the exercise intervention or control group. We will conduct measures at baseline, at 8 weeks, and at 3-month intervals for 2 years following the intervention. The exercise component of the intervention will include lower extremity muscle strengthening, range-of-motion exercises, and fitness walking. An educational component will focus on arthritis self-efficacy and perceived self-reported exercise efficacy. We hypothesize that treatment group participants will exhibit higher rates of adherence to exercise and higher functional status outcomes over time compared to controls.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Fit and Strong!Fit and Strong! is a multi-component exercise and health education program that incorporates flexibility, aerobic conditioning, strength training, and group discussion/problem solving for lifestyle change. |
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 of the lower extremities with an American College of Rheumatology functional class rating of I, II, or III
- No other contraindication from a personal physician for participation in the fitness walking
- Lack of moderate-to-severe cognitive impairment as assessed by the Short Portable Mental Status Questionnaire
Key exclusion criteria (11 listed)
- Under 60 years of age
- Lack of osteoarthritis of the lower extremities
- Contraindication from a personal physician for participation in fitness walking
- Presence of moderate-to-severe cognitive impairment as assessed by the Short Portable Mental Status Questionnaire
- Steroid injections in either hip or knee within the previous 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 |
|---|---|---|
| Fit and Strong!Fit and Strong! is a multi-component exercise and health education program that includes flexibility, aerobic conditioning, strength training, and group discussion/problem solving for lifestyle change. | Behavioural | 1 |
Primary outcome
Adherence to exercise
Time frame: 12 months
1 secondary outcome
Pain and stiffness
Time frame: 12 months
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 22 Aug 2019.
- 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.
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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 principal investigator
Center for Research on Health and Aging
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fit and Strong! in people with Osteoarthritis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 2 sites 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: finished, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Adherence to exercise (time frame: 12 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 NCT00000434, which also lists 2 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 22 Aug 2019.