Hip OsteoarthritisNCT00682617
Hip Osteoarthritis: Effects of Exercise Programs on Pain and Disability
A study testing Structured exercise program and Waitlist, delayed intervention in people with Hip Osteoarthritis, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Osteoarthritis is the most common form of arthritis in the United States. It is estimated that 20 million Americans have arthritis, and the annual societal cost is $95 billion. Several exercise studies have shown modest improvements in disability, physical performance, and pain in subjects with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Structured exercise program and Waitlist, delayed intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2007to 11 Nov 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21 years or more
- Pain at least once a week in one or both hips
- Difficulty with at least one of the following secondary to hip pain: walking 1/4 mile, climbing stairs, getting in and out of a car, rising from a chair, lifting and carrying groceries, getting out or bed, getting out of the bathtub, or performing shopping, cleaning or self-care activities
- Radiographic evidence of femoral and/or acetabular osteophytes on radiograph -OR- radiographic evidence of axial joint space narrowing and active hip flexion </= 115 degrees
- Primary care physician's written consent to participate in the exercise-based protocol. If te subject does not have a primary care physician, the subject will complete a screening questionnaire for coronary artery disease. If the subject screens as "high risk", te subject will be excluded from the study
Who cannot join
- A medical condition that precludes safe participation in an exercise program including active cardiac disease, angina, class III heart failure, myocardial infarction in the past year
- Screening as "high risk" for coronary artery disease
- Inflammatory arthritis (e.g. psoriatic or rheumatoid)
- Collecting workers' compensation
- Involved in litigation regarding pain and/or disability
- Unable to walk six minutes without cane or assistive device
Show all 10Show fewer
- Participating in a conflicting research study
- Significant, symptomatic knee or ankle osteoarthritis
- Other lower extremity pathology including peripheral vascular disease that would preclude participation in an exercise program
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University Center for Health & Healing
Portland, Oregon, 97239
About this study
Official title: Hip Osteoarthritis: Effects of Structured Exercise Programs on Pain and Long-term Disability
Osteoarthritis is the most common form of arthritis in the United States. It is estimated that 20 million Americans have arthritis, and the annual societal cost is $95 billion. Several exercise studies have shown modest improvements in disability, physical performance, and pain in subjects with knee osteoarthritis. While similar results have been suggested in hip osteoarthritis, well-designed randomized clinical trials have not been conducted. Exercise programs appear beneficial but without adherence, the beneficial effects of exercise for knee and hip osteoarthritis decline over time. A well-designed, evidence-based, arthritis-specific study controlling for exercise duration, frequency and adherence is needed. The objective of this study is to determine the effects of structured exercise programs on self-reported pain and disability in adults with hip osteoarthritis. This prospective, randomized study with a wait-list control is designed to develop preliminary data to support an R01 funding request for a large, randomized clinical trial. All exercise interventions and outcome assessments will take place at OHSU in the Orthopaedics and Rehabilitation Clinics, Rehabilitation Services physical therapy gym, and the General Clinical Research Center. Subjects will be selected to include individuals representative of the larger population with documented hip osteoarthritis. This three-month study will evaluate the effects of an aerobic and resistance exercise program on pain and disability in individuals with hip osteoarthritis. Outcome assessment will follow the Outcome Measures in Rheumatology (OMERACT) recommendations for a core set of outcome measures for clinical trials in arthritis and assess pain, physical function, patient global assessment, and joint imaging. Data analysis will focus on comparing pre- and post-intervention endpoints using conventional statistical analyses such as repeated-measure analysis of variance for repeated continuous measures (e.g. walking distance), and non-parametric methods such as Chi-square or frequency analysis for proportions (e.g. visual pain scores).
- Conditions
- Hip Osteoarthritis
- Being tested
- Structured exercise program, Waitlist, delayed intervention
- Keywords
- hip, osteoarthritis, exercise, disability, physical function
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured exercise programBehavioural
Also called Group 2
Exercise intervention will consist of a three-month, supervised, facility-based, hip-specific strengthening, flexibility, and endurance exercise program. The intervention will consist of two phases and take place at OHSU rehabilitation services. Phase 1 will be a two-week orientation and general conditioning program. Phase 2 will be a ten-week progressive workload program. Subjects in both Phase 1 and Phase 2 will meet two to three times per week for 45 minutes per session. Phase 1 will be group sessions with more individualized orientation and attention by the exercise instructors. Phase 2 will begin progressive conditioning and utilize exercise groups of four to six subjects.
Waitlist, delayed interventionBehavioural
Also called Group 1
Due to limited space in exercise intervention classes, subjects may be placed on a waitlist for 3 months. When an opening becomes available, the subject will begin the exercise program identical to that of Group 2
| Study group | Role | What they receive |
|---|---|---|
| Waitlist Control | Experimental | Delayed intervention. 3 months on waitlist, crossover to intervention (3 additional months) Receives: Behavioral: Waitlist, delayed intervention |
| 3 Month Exercise Program | Experimental | 3 month exercise program Receives: Behavioral: Structured exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-minute Walk Test
Calculated as change from baseline to 3 months
Measured: 3 months
Secondary outcomes (2)
Change in Pain Visual Analog Scale
Evaluated using a 100mm pain VAS (range 0-100), with higher scores indicating worse pain. Calculated as change from baseline to 3 months.
Measured: 3 months
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale
The WOMAC Physical Function Subscale has a range of 0-68, with higher scores indicating worse functional limitations. Calculated as change from baseline to 3 months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study start23 May 2007
- Primary completion11 Nov 2010
- Study completion11 Nov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nels Carlson, Oregon Health and Science University
- Investigators
- Nels Carlson, M.D., Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682617
- Sponsor's protocol ID
- IRB #290
- Status last verified
- Mar 2020
- First submitted
- 20 May 2008
- Last updated
- 24 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Thompson AR, Christopherson Z, Marshall LM, Carlson HL, Carlson NL. A Pilot Randomized Controlled Trial for Aerobic and Strengthening Exercises on Physical Function and Pain for Hip Osteoarthritis. PM R. 2020 Mar;12(3):229-237. doi: 10.1002/pmrj.12262. Epub 2019 Dec 12.
PubMed 31600429
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip Osteoarthritis: Effects of Structured Exercise Programs on Pain and Long-term Disability
- ClinicalTrials.gov ID
- NCT00682617
- Acronym / sponsor ID
- IRB #290
- Conditions
- Hip Osteoarthritis
- Keywords
- hip, osteoarthritis, exercise, disability, physical function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 23 May 2007 (actual)
- Primary completion
- 11 Nov 2010 (actual)
- Study completion
- 11 Nov 2010 (actual)
- First posted
- 22 May 2008 (estimated)
- Results
- Posted 24 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoarthritis is the most common form of arthritis in the United States. It is estimated that 20 million Americans have arthritis, and the annual societal cost is $95 billion. Several exercise studies have shown modest improvements in disability, physical performance, and pain in subjects with knee osteoarthritis. While similar results have been suggested in hip osteoarthritis, well-designed randomized clinical trials have not been conducted. Exercise programs appear beneficial but without adherence, the beneficial effects of exercise for knee and hip osteoarthritis decline over time. A well-designed, evidence-based, arthritis-specific study controlling for exercise duration, frequency and adherence is needed. The objective of this study is to determine the effects of structured exercise programs on self-reported pain and disability in adults with hip osteoarthritis. This prospective, randomized study with a wait-list control is designed to develop preliminary data to support an R01 funding request for a large, randomized clinical trial. All exercise interventions and outcome assessments will take place at OHSU in the Orthopaedics and Rehabilitation Clinics, Rehabilitation Services physical therapy gym, and the General Clinical Research Center. Subjects will be selected to include individuals representative of the larger population with documented hip osteoarthritis. This three-month study will evaluate the effects of an aerobic and resistance exercise program on pain and disability in individuals with hip osteoarthritis. Outcome assessment will follow the Outcome Measures in Rheumatology (OMERACT) recommendations for a core set of outcome measures for clinical trials in arthritis and assess pain, physical function, patient global assessment, and joint imaging. Data analysis will focus on comparing pre- and post-intervention endpoints using conventional statistical analyses such as repeated-measure analysis of variance for repeated continuous measures (e.g. walking distance), and non-parametric methods such as Chi-square or frequency analysis for proportions (e.g. visual pain scores).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waitlist Control | Experimental | Behavioral: Waitlist, delayed interventionDelayed intervention. 3 months on waitlist, crossover to intervention (3 additional months) |
| 3 Month Exercise Program | Experimental | Behavioral: Structured exercise program3 month exercise program |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 21 years or more
- Pain at least once a week in one or both hips
- Difficulty with at least one of the following secondary to hip pain: walking 1/4 mile, climbing stairs, getting in and out of a car, rising from a chair, lifting and carrying groceries, getting out or bed, getting out of the bathtub, or performing shopping, cleaning or self-care activities
- Radiographic evidence of femoral and/or acetabular osteophytes on radiograph -OR- radiographic evidence of axial joint space narrowing and active hip flexion </= 115 degrees
- Primary care physician's written consent to participate in the exercise-based protocol. If te subject does not have a primary care physician, the subject will complete a screening questionnaire for coronary artery disease. If the subject screens as "high risk", te subject will be excluded from the study
Key exclusion criteria (10 listed)
- A medical condition that precludes safe participation in an exercise program including active cardiac disease, angina, class III heart failure, myocardial infarction in the past year
- Screening as "high risk" for coronary artery disease
- Inflammatory arthritis (e.g. psoriatic or rheumatoid)
- Collecting workers' compensation
- Involved in litigation regarding pain and/or disability
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 |
|---|---|---|
| Structured exercise programAlso: Group 2Exercise intervention will consist of a three-month, supervised, facility-based, hip-specific strengthening, flexibility, and endurance exercise program. The intervention will consist of two phases and take place at OHSU rehabilitation services. Phase 1 will be a two-week orientation and general conditioning program. Phase 2 will be a ten-week progressive workload program. Subjects in both Phase 1 and Phase 2 will meet two to three times per week for 45 minutes per session. Phase 1 will be group sessions with more individualized orientation and attention by the exercise instructors. Phase 2 will begin progressive conditioning and utilize exercise groups of four to six subjects. | Behavioural | 3 Month Exercise Program |
| Waitlist, delayed interventionAlso: Group 1Due to limited space in exercise intervention classes, subjects may be placed on a waitlist for 3 months. When an opening becomes available, the subject will begin the exercise program identical to that of Group 2 | Behavioural | Waitlist Control |
Primary outcome
Change in 6-minute Walk Test
Time frame: 3 months
Calculated as change from baseline to 3 months
2 secondary outcomes
Change in Pain Visual Analog Scale
Time frame: 3 months
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31600429Thompson AR, Christopherson Z, Marshall LM, Carlson HL, Carlson NL. A Pilot Randomized Controlled Trial for Aerobic and Strengthening Exercises on Physical Function and Pain for Hip Osteoarthritis. PM R. 2020 Mar;12(3):229-237. doi: 10.1002/pmrj.12262. Epub 2019 Dec 12.
Related trials for Hip Osteoarthritis
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
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.
Nels Carlson, M.D. principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured exercise program and Waitlist, delayed intervention in people with Hip Osteoarthritis, run by Oregon Health and Science University 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 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 24 Mar 2020. 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?
Yes. Results are posted in the registry (first posted 24 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in 6-minute Walk Test (time frame: 3 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 NCT00682617, 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 24 Mar 2020.