OsteoarthritisNCT00613678
Exercise Plus Activity Strategy Training for Osteoarthritis
A study testing Activity Strategy Training and Education in people with Osteoarthritis, run by University of Michigan at 1 site in United States.
Trial summary
Purpose: To study the effects of two different rehabilitation programs for people with osteoarthritis of the hip or knee. Hypothesis 1: Participants who received Activity Stratgey Training will report less pain and physical disability at 8-weeks and 6-months follow-up. Read more about this study
- Who is it for?
- Ages 62 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Activity Strategy Training and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Apr 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 62 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum age of 62 years
- Meet ACR clinical criteria for either hip or knee OA
- Ambulatory (with or without assistance)
- Requiring assistance or report difficulty in >=1/4 activities of daily living
- Ability to speak English
Who cannot join
- Knee/hip surgery within the previous 9 mos.
- Current participation in physical/occupational therapy
- Any contraindication to exercise activities
- Cognitive impairment
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Institute of Gerontology
Ann Arbor, Michigan, 48109-2007
About this study
Official title: Exercise Plus Activity Strategy Training for Older Adults With Osteoarthritis
Purpose: To study the effects of two different rehabilitation programs for people with osteoarthritis of the hip or knee.
Hypothesis 1: Participants who received Activity Stratgey Training will report less pain and physical disability at 8-weeks and 6-months follow-up.
Hypothesis 2: Participants who receive Activity Strategy Training will have a greater increase in physical activity as measured by a wrist-worn accelerometer.
Hypothesis 3: Participants who receive Activity Stratgey Training will report greater improvements in health-related quality of life.
Read the detailed description
We are testing the effectiveness of a targeted intervention for older adults with hip and/or knee osteoarthritis (LE-OA) using an occupational therapy treatment approach to promote activity engagement. We believe that it is necessary to tailor this intervention to the specific needs of older adults with LE-OA. Based on the literature, exercise is a necessary component of an intervention for older adults with LE-OA. However, this should also be coupled with an Activity Strategy Training (AST) component designed to promote lifestyle changes and thus more lasting effects. The AST component is based on occupational therapy principles and will include behavioral and environmental strategies to increase activity engagement.
- Conditions
- Osteoarthritis
- Being tested
- Activity Strategy Training, Education
- Keywords
- pain, activities of daily living, symptoms, self-management
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity Strategy TrainingBehavioural
The AST component will involve training in specific behavioral and environmental strategies to facilitate performance in daily activities and routines. The activity strategy training group sessions will use education, group discussion, and demonstration and practice of techniques to facilitate activity performance. Homework assignments will be given after many of the sessions to practice and reinforce concepts learned.
EducationBehavioural
The health education program is based on educational materials from the Arthritis Foundation.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Exercise + Education: Eight group sessions (8-15 people) during which participants engage in muscular strength and flexibility exercises. In addition, weekly educational lectures on topics germane to osteoarthritis management are included. Receives: Behavioral: Education |
| 2 | Experimental | Exercise + Activity Strategy Training: 7/8 sessions will be in a group format in which participants engage in muscular strength \& flexibility exercises and listen to education lessons on management strategies for osteoarthritis. The remaining session includes a home assessment by an occupational therapist to facilitate adequate participation in daily living and leisure activities. Receives: Behavioral: Activity Strategy Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported pain
Measured: Baseline, Post-intervention (8-wks), and 6-mos follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJul 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Murphy, University of Michigan
- Investigators
- Susan L Murphy, ScD, OTR, Principal investigator, University of Michigan, Institute of Gerontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613678
- Sponsor's protocol ID
- ACT
- Status last verified
- Aug 2015
- First submitted
- 31 Jan 2008
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Murphy SL, Strasburg DM, Lyden AK, Smith DM, Koliba JF, Dadabhoy DP, Wallis SM. Effects of activity strategy training on pain and physical activity in older adults with knee or hip osteoarthritis: a pilot study. Arthritis Rheum. 2008 Oct 15;59(10):1480-7. doi: 10.1002/art.24105.
PubMed 18821646
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Plus Activity Strategy Training for Older Adults With Osteoarthritis
- ClinicalTrials.gov ID
- NCT00613678
- Acronym / sponsor ID
- ACT
- Conditions
- Osteoarthritis
- Keywords
- pain, activities of daily living, symptoms, self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 13 Feb 2008 (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.
Purpose: To study the effects of two different rehabilitation programs for people with osteoarthritis of the hip or knee.
Hypothesis 1: Participants who received Activity Stratgey Training will report less pain and physical disability at 8-weeks and 6-months follow-up.
Hypothesis 2: Participants who receive Activity Strategy Training will have a greater increase in physical activity as measured by a wrist-worn accelerometer.
Hypothesis 3: Participants who receive Activity Stratgey Training will report greater improvements in health-related quality of life.
Detailed description
We are testing the effectiveness of a targeted intervention for older adults with hip and/or knee osteoarthritis (LE-OA) using an occupational therapy treatment approach to promote activity engagement. We believe that it is necessary to tailor this intervention to the specific needs of older adults with LE-OA. Based on the literature, exercise is a necessary component of an intervention for older adults with LE-OA. However, this should also be coupled with an Activity Strategy Training (AST) component designed to promote lifestyle changes and thus more lasting effects. The AST component is based on occupational therapy principles and will include behavioral and environmental strategies to increase activity engagement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: EducationExercise + Education: Eight group sessions (8-15 people) during which participants engage in muscular strength and flexibility exercises. In addition, weekly educational lectures on topics germane to osteoarthritis management are included. |
| 2 | Experimental | Behavioral: Activity Strategy TrainingExercise + Activity Strategy Training: 7/8 sessions will be in a group format in which participants engage in muscular strength \& flexibility exercises and listen to education lessons on management strategies for osteoarthritis. The remaining session includes a home assessment by an occupational therapist to facilitate adequate participation in daily living and leisure activities. |
Who may qualify
- Ages
- 62 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Minimum age of 62 years
- Meet ACR clinical criteria for either hip or knee OA
- Ambulatory (with or without assistance)
- Requiring assistance or report difficulty in >=1/4 activities of daily living
- Ability to speak English
Key exclusion criteria (5 listed)
- Knee/hip surgery within the previous 9 mos.
- Current participation in physical/occupational therapy
- Any contraindication to exercise activities
- Cognitive impairment
- Inability to provide informed consent
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 |
|---|---|---|
| Activity Strategy TrainingThe AST component will involve training in specific behavioral and environmental strategies to facilitate performance in daily activities and routines. The activity strategy training group sessions will use education, group discussion, and demonstration and practice of techniques to facilitate activity performance. Homework assignments will be given after many of the sessions to practice and reinforce concepts learned. | Behavioural | 2 |
| EducationThe health education program is based on educational materials from the Arthritis Foundation. | Behavioural | 1 |
Primary outcome
Self-reported pain
Time frame: Baseline, Post-intervention (8-wks), and 6-mos follow-up
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 Aug 2015.
- Derived from this study: PubMed 18821646Murphy SL, Strasburg DM, Lyden AK, Smith DM, Koliba JF, Dadabhoy DP, Wallis SM. Effects of activity strategy training on pain and physical activity in older adults with knee or hip osteoarthritis: a pilot study. Arthritis Rheum. 2008 Oct 15;59(10):1480-7. doi: 10.1002/art.24105.
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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 L Murphy, ScD, OTR principal investigator
University of Michigan, Institute of Gerontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity Strategy Training and Education in people with Osteoarthritis, run by University of Michigan 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 5 inclusion and 5 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 5 Aug 2015. 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?
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?
Self-reported pain (time frame: Baseline, Post-intervention (8-wks), and 6-mos follow-up). 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 NCT00613678, which also lists 1 linked publication.
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 Aug 2015.