OsteoarthritisNCT00586300
Community-Based Programs for Improving Physical Function in People With Early Knee Osteoarthritis
A study testing Physical training program, Self-management training program and Physical training and self-management training programs in people with Osteoarthritis, run by University of Arizona at 1 site in United States.
Trial summary
Osteoarthritis (OA) is the most common joint-related disease and most prevalent form of arthritis in the United States. Pain relievers and anti-inflammatory medications are the most commonly prescribed treatments for OA. These medications, however, cannot completely alleviate OA symptoms. Read more about this study
- Who is it for?
- Ages 35 to 64 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Physical training program, Self-management training program and Physical training and self-management training programs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to May 2009
- 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 35 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of pain on most days (i.e., 4 or more days in a week) in one or both knees for at least 4 months during the year prior to study entry
- Duration of symptoms (defined as pain on most days for at least 4 months in 1 year) of less than 5 years
- Radiographic evidence of grade II knee OA
- Some level of disability, represented as a score of 3 or higher for at least three of the following WOMAC Index items: descending or ascending stairs; walking; bending; and performing daily activities
Who cannot join
- Any uncontrolled medical condition that could prevent safe participation in the study (e.g., uncontrolled heart disease, blood pressure, or respiratory conditions)
- Any neurological condition that could affect coordination
- Inflammatory arthritis (e.g., rheumatoid or psoriatic arthritis)
- Participates in aerobic activity or resistance training for more than 60 minutes per week
- History of knee surgery
- Radiographic grade I, III-IV (Kellgren and Lawrence classification)
Show all 10Show fewer
- Body mass index of at most 37.5 Kg/m2 (Individuals over this limit will be advised to follow a weight loss program and achieve stable weight for 6 months prior to participation.)
- History of a knee corticosteroid injection in the 3 months prior to study entry
- Plans to move from the local area
- Plans to become pregnant during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multidimensional Intervention in Early Osteoarthritis (The Knee Study)
Osteoarthritis (OA) is the most common joint-related disease and most prevalent form of arthritis in the United States. Pain relievers and anti-inflammatory medications are the most commonly prescribed treatments for OA. These medications, however, cannot completely alleviate OA symptoms. Additional recommended strategies for managing OA include physical and occupational therapy, exercise, and patient education. This study will compare the effectiveness of a physical training program, a self-management training program, and a program including both physical and self-management training for improving physical function in people with early stage knee OA.
Read the detailed description
There is no cure for arthritis; therefore, it is important to develop treatments to effectively manage the disease. The primary goals of arthritis management are to reduce pain and improve functional ability and quality of life. Existing treatments, including pain relievers and anti-inflammatory medications, can only partially manage OA symptoms. Few studies, however, have been conducted to evaluate complementary measures, such as exercise and education. This study will compare a physical training program, a self-management training program, and a program including both physical and self-management training to determine their effectiveness in improving physical function in people with early stage knee OA.
Participants in this 2-year study will first undergo a physical evaluation that will include answering a questionnaire and having knee x-rays. Participants will then be randomly assigned to one of three treatment groups. All three treatments will include a 9-month supervised phase (Phase 1) and a 15-month maintenance phase (Phase 2).
- Group 1 participants will partake in a community-based arthritis self-management program. Phase 1 will include weekly 75-minute training sessions for 3 months. These sessions will be led by healthcare professionals and will address topics about arthritis and its treatment, healthy lifestyle, and physical activity. After completing the training sessions, participants will be contacted weekly by telephone for 3 months to discuss their progress. Then the telephone contacts will occur once every other week for the next 3 months. During Phase 2 of the self-management training program, participants will continue to receive telephone contacts from the project team to help support and promote the skills introduced during the training sessions. These contacts will occur monthly for 3 months and then every other month for the remainder of the study.
- Group 2 participants will first attend an orientation workshop and then start a long-term physical training program that will include components of balance, flexibility, muscle strengthening, and aerobic conditioning. During Phase 1, participants will attend three physical training sessions per week. During Phase 2, participants will have the option to continue the program in the location of their choice. Study staff will contact participants monthly by phone to discuss their progress. Participants may meet with the trainer on an as-needed basis for additional assistance with the program. They will also keep a log to track attendance and progress, and they will mail in the log monthly.
- Group 3 participants will complete both the physical and self-management training programs and will follow the schedules outlined for Groups 1 and 2.
All participants will complete questionnaires before beginning their assigned training programs and then every 3 months till Month 24. The questionnaires will take between 30 and 60 minutes to complete. At various times during the study, participants will measure their activity levels with a pedometer or an accelerometer. Prior to starting the training programs, at Month 9, and after completing the training programs, participants will complete several tests to measure their physical capabilities and muscle strength. Upon completing the training programs, participants will receive a follow-up x-ray of their knees at an assigned radiology clinic. They will also be asked to provide feedback on their study experiences via a mailer questionnaire, and they may be asked to provide feedback in a short telephone interview.
- Conditions
- Osteoarthritis
- Being tested
- Physical training program, Self-management training program, Physical training and self-management training programs
- Keywords
- Knee pain
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical training programOther
Also called Exercise group
The physical training will be completed in two phases. In Phase 1, which will last 9 months, participants will complete the program under the supervision of an experienced trainer. Sessions will occur three times each week in a designated study facility. The program will include the following components: stretching and balance, flexibility and range of motion, muscle strengthening, and aerobics. The program will also emphasize the importance of individualizing exercise regimens according to each person's specific needs (function and fitness). In Phase 2, the primary objective will be to promote long-term exercise (for up to 24 months from the time of study entry) that incorporates the four modalities of exercise instruction introduced in Phase 1, but on an independent basis.
Self-management training programBehavioural
The self-management training program is designed to target primarily coping skills and self-efficacy. This will be accomplished by using a variety of educational and behavioral methods. The program will be delivered in two phases. The initial 9-month phase will consist of 12 weekly 60-minute classroom sessions, followed by 24 weeks of a structured telephone intervention program. Phase 2 will continue to incorporate the telephone intervention program, at less frequent intervals, for up to 24 months from the time of study entry.
Physical training and self-management training programsOther
Also called Combo Group
This "multidimensional" intervention will combine both the physical training and self-management training programs described for Groups 1 and 2.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Physical training program Receives: Other: Physical training program |
| 2 | Active comparator | Self-management training program Receives: Behavioral: Self-management training program |
| 3 | Active comparator | Physical and self-management training programs Receives: Other: Physical training and self-management training programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee function, as measured by the ERGOS machine
Measured: Measured at baseline and Months 9 and 24
Secondary outcomes (7)
Pain, as measured by the visual analogue scale (VAS) and the Pain Subscale of the Western Ontario and MacMasters Universities (WOMAC)
Measured: Measured at baseline and Months 3, 9, 18, and 24
Coping efficacy, self-efficacy, and health-related quality of life, as measured by the Client Satisfaction Questionnaire (CSQ)
Measured: Measured at baseline and Months 3, 9, 18, and 24
Arthritis self-efficacy scale
Measured: Measured at baseline and Months 3, 9, 18, and 24
Positive and Negative Affect Schedule (PANAS)
Measured: Measured at baseline and Months 3, 9, 18, and 24
SF-36 Health Survey
Measured: Measured at baseline and Months 3, 9, 18, and 24
EuroQuol
Measured: Measured at baseline and Months 3, 9, 18, and 24
Medical Outcomes Social Support Survey
Measured: Measured at baseline and Months 3, 9, 18, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startJun 2003
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Scott Going, University of Arizona
- Investigators
- Scott B. Going, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586300
- Sponsor's protocol ID
- R01AR047595
- Other IDs
- R01AR047595
- Status last verified
- Jun 2012
- First submitted
- 28 Dec 2007
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Wright LJ, Zautra AJ, Going S. Adaptation to early knee osteoarthritis: the role of risk, resilience, and disease severity on pain and physical functioning. Ann Behav Med. 2008 Aug;36(1):70-80. doi: 10.1007/s12160-008-9048-5. Epub 2008 Aug 21.
PubMed 18716855McKnight PE, Kasle S, Going S, Villanueva I, Cornett M, Farr J, Wright J, Streeter C, Zautra A. A comparison of strength training, self-management, and the combination for early osteoarthritis of the knee. Arthritis Care Res (Hoboken). 2010 Jan 15;62(1):45-53. doi: 10.1002/acr.20013.
PubMed 20191490Farr JN, Going SB, McKnight PE, Kasle S, Cussler EC, Cornett M. Progressive resistance training improves overall physical activity levels in patients with early osteoarthritis of the knee: a randomized controlled trial. Phys Ther. 2010 Mar;90(3):356-66. doi: 10.2522/ptj.20090041. Epub 2010 Jan 7.
PubMed 20056719Farr JN, Going SB, Lohman TG, Rankin L, Kasle S, Cornett M, Cussler E. Physical activity levels in patients with early knee osteoarthritis measured by accelerometry. Arthritis Rheum. 2008 Sep 15;59(9):1229-36. doi: 10.1002/art.24007.
PubMed 18759320
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Intervention in Early Osteoarthritis (The Knee Study)
- ClinicalTrials.gov ID
- NCT00586300
- Acronym / sponsor ID
- R01AR047595
- Conditions
- Osteoarthritis
- Keywords
- Knee pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jun 2003
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 4 Jan 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.
Osteoarthritis (OA) is the most common joint-related disease and most prevalent form of arthritis in the United States. Pain relievers and anti-inflammatory medications are the most commonly prescribed treatments for OA. These medications, however, cannot completely alleviate OA symptoms. Additional recommended strategies for managing OA include physical and occupational therapy, exercise, and patient education. This study will compare the effectiveness of a physical training program, a self-management training program, and a program including both physical and self-management training for improving physical function in people with early stage knee OA.
Detailed description
There is no cure for arthritis; therefore, it is important to develop treatments to effectively manage the disease. The primary goals of arthritis management are to reduce pain and improve functional ability and quality of life. Existing treatments, including pain relievers and anti-inflammatory medications, can only partially manage OA symptoms. Few studies, however, have been conducted to evaluate complementary measures, such as exercise and education. This study will compare a physical training program, a self-management training program, and a program including both physical and self-management training to determine their effectiveness in improving physical function in people with early stage knee OA.
Participants in this 2-year study will first undergo a physical evaluation that will include answering a questionnaire and having knee x-rays. Participants will then be randomly assigned to one of three treatment groups. All three treatments will include a 9-month supervised phase (Phase 1) and a 15-month maintenance phase (Phase 2).
- Group 1 participants will partake in a community-based arthritis self-management program. Phase 1 will include weekly 75-minute training sessions for 3 months. These sessions will be led by healthcare professionals and will address topics about arthritis and its treatment, healthy lifestyle, and physical activity. After completing the training sessions, participants will be contacted weekly by telephone for 3 months to discuss their progress. Then the telephone contacts will occur once every other week for the next 3 months. During Phase 2 of the self-management training program, participants will continue to receive telephone contacts from the project team to help support and promote the skills introduced during the training sessions. These contacts will occur monthly for 3 months and then every other month for the remainder of the study.
- Group 2 participants will first attend an orientation workshop and then start a long-term physical training program that will include components of balance, flexibility, muscle strengthening, and aerobic conditioning. During Phase 1, participants will attend three physical training sessions per week. During Phase 2, participants will have the option to continue the program in the location of their choice. Study staff will contact participants monthly by phone to discuss their progress. Participants may meet with the trainer on an as-needed basis for additional assistance with the program. They will also keep a log to track attendance and progress, and they will mail in the log monthly.
- Group 3 participants will complete both the physical and self-management training programs and will follow the schedules outlined for Groups 1 and 2.
All participants will complete questionnaires before beginning their assigned training programs and then every 3 months till Month 24. The questionnaires will take between 30 and 60 minutes to complete. At various times during the study, participants will measure their activity levels with a pedometer or an accelerometer. Prior to starting the training programs, at Month 9, and after completing the training programs, participants will complete several tests to measure their physical capabilities and muscle strength. Upon completing the training programs, participants will receive a follow-up x-ray of their knees at an assigned radiology clinic. They will also be asked to provide feedback on their study experiences via a mailer questionnaire, and they may be asked to provide feedback in a short telephone interview.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Physical training programPhysical training program |
| 2 | Active comparator | Behavioral: Self-management training programSelf-management training program |
| 3 | Active comparator | Other: Physical training and self-management training programsPhysical and self-management training programs |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- History of pain on most days (i.e., 4 or more days in a week) in one or both knees for at least 4 months during the year prior to study entry
- Duration of symptoms (defined as pain on most days for at least 4 months in 1 year) of less than 5 years
- Radiographic evidence of grade II knee OA
- Some level of disability, represented as a score of 3 or higher for at least three of the following WOMAC Index items: descending or ascending stairs; walking; bending; and performing daily activities
Key exclusion criteria (10 listed)
- Any uncontrolled medical condition that could prevent safe participation in the study (e.g., uncontrolled heart disease, blood pressure, or respiratory conditions)
- Any neurological condition that could affect coordination
- Inflammatory arthritis (e.g., rheumatoid or psoriatic arthritis)
- Participates in aerobic activity or resistance training for more than 60 minutes per week
- History of knee surgery
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 training programAlso: Exercise groupThe physical training will be completed in two phases. In Phase 1, which will last 9 months, participants will complete the program under the supervision of an experienced trainer. Sessions will occur three times each week in a designated study facility. The program will include the following components: stretching and balance, flexibility and range of motion, muscle strengthening, and aerobics. The program will also emphasize the importance of individualizing exercise regimens according to each person's specific needs (function and fitness). In Phase 2, the primary objective will be to promote long-term exercise (for up to 24 months from the time of study entry) that incorporates the four modalities of exercise instruction introduced in Phase 1, but on an independent basis. | Other | 1 |
| Self-management training programThe self-management training program is designed to target primarily coping skills and self-efficacy. This will be accomplished by using a variety of educational and behavioral methods. The program will be delivered in two phases. The initial 9-month phase will consist of 12 weekly 60-minute classroom sessions, followed by 24 weeks of a structured telephone intervention program. Phase 2 will continue to incorporate the telephone intervention program, at less frequent intervals, for up to 24 months from the time of study entry. | Behavioural | 2 |
| Physical training and self-management training programsAlso: Combo GroupThis "multidimensional" intervention will combine both the physical training and self-management training programs described for Groups 1 and 2. | Other | 3 |
Primary outcome
Knee function, as measured by the ERGOS machine
Time frame: Measured at baseline and Months 9 and 24
7 secondary outcomes
Pain, as measured by the visual analogue scale (VAS) and the Pain Subscale of the Western Ontario and MacMasters Universities (WOMAC)
Time frame: Measured at baseline and Months 3, 9, 18, and 24
Coping efficacy, self-efficacy, and health-related quality of life, as measured by the Client Satisfaction Questionnaire (CSQ)
Time frame: Measured at baseline and Months 3, 9, 18, and 24
Arthritis self-efficacy scale
Time frame: Measured at baseline and Months 3, 9, 18, and 24
Positive and Negative Affect Schedule (PANAS)
Time frame: Measured at baseline and Months 3, 9, 18, and 24
SF-36 Health Survey
Time frame: Measured at baseline and Months 3, 9, 18, and 24
EuroQuol
Time frame: Measured at baseline and Months 3, 9, 18, and 24
Medical Outcomes Social Support Survey
Time frame: Measured at baseline and Months 3, 9, 18, and 24
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 21 Jun 2012.
- Results publication: PubMed 18716855Wright LJ, Zautra AJ, Going S. Adaptation to early knee osteoarthritis: the role of risk, resilience, and disease severity on pain and physical functioning. Ann Behav Med. 2008 Aug;36(1):70-80. doi: 10.1007/s12160-008-9048-5. Epub 2008 Aug 21.
- Derived from this study: PubMed 20191490McKnight PE, Kasle S, Going S, Villanueva I, Cornett M, Farr J, Wright J, Streeter C, Zautra A. A comparison of strength training, self-management, and the combination for early osteoarthritis of the knee. Arthritis Care Res (Hoboken). 2010 Jan 15;62(1):45-53. doi: 10.1002/acr.20013.
- Derived from this study: PubMed 20056719Farr JN, Going SB, McKnight PE, Kasle S, Cussler EC, Cornett M. Progressive resistance training improves overall physical activity levels in patients with early osteoarthritis of the knee: a randomized controlled trial. Phys Ther. 2010 Mar;90(3):356-66. doi: 10.2522/ptj.20090041. Epub 2010 Jan 7.
- Derived from this study: PubMed 18759320Farr JN, Going SB, Lohman TG, Rankin L, Kasle S, Cornett M, Cussler E. Physical activity levels in patients with early knee osteoarthritis measured by accelerometry. Arthritis Rheum. 2008 Sep 15;59(9):1229-36. doi: 10.1002/art.24007.
- Click here for more information about the Knee StudyLink provided by the sponsor.
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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.
Scott B. Going, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical training program, Self-management training program and Physical training and self-management training programs in people with Osteoarthritis, run by University of Arizona 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 10 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 21 Jun 2012. 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?
Knee function, as measured by the ERGOS machine (time frame: Measured at baseline and Months 9 and 24). 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 NCT00586300, which also lists 4 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 21 Jun 2012.