Osteoarthritis, KneeNCT00427843
The Influence of Hip Strengthening Exercises on Walking Patterns and Muscle Strength in Persons With Knee Osteoarthritis
A study testing home exercise program for the hip abductor muscles in people with Osteoarthritis, Knee, run by Queen's University at 1 site in Canada.
Trial summary
The purpose of this study is to determine the influence of a home program of exercises for the hip muscles which support the pelvis on walking patterns and hip muscle strength in people with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- home exercise program for the hip abductor muscles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2007to 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age greater than or equal to 40 years
- self-reported pain in the knee(s) for most days of the month
- at least some difficulty in daily function due to knee osteoarthritis
- radiographic evidence of knee osteoarthritis or documented evidence of cartilage loss in the knee by arthroscopy surgery or magnetic resonance imaging.
Who cannot join
- corticosteroid injection into either knee within the previous three months
- other significant medical problems (including significant heart disease, stroke and active treatment for cancer) that would prevent participants from being able to perform a hip exercise program or to participate in tests of walking performance and hip muscle strength
- known osteoarthritis or previous trauma affecting one or both hips
- previous replacement of any joint in the lower extremities.
- receiving rehabilitation services for knee osteoarthritis or performing a hip strengthening program at the time of testing
- participants who have had a dual-energy x-ray absorptiometry (DEXA) for bone density analysis or more than one x-ray of the chest, abdomen or hip in the past 6 months
Trial locations and contacts
1 site in 1 country.
Canada1 site
School of Rehabilitation Therapy, Queen's University
Kingston, Ontario, K7L 3N6
About this study
Official title: The Influence of a Home Program of Hip Abductor Exercises on Gait Parameters and Muscle Strength in Persons With Knee Osteoarthritis
The purpose of this study is to determine the influence of a home program of exercises for the hip muscles which support the pelvis on walking patterns and hip muscle strength in people with knee osteoarthritis. Following a hip muscle strengthening program, we hypothesize that participants with knee osteoarthritis will demonstrate decreased loading at the knee joint during walking and greater strength of the hip muscles.
Read the detailed description
Knee osteoarthritis is a common age-related impairment that may progress to cause significant pain and physical disability. Excessive loading at the knee joint is believed to contribute to the progression of knee osteoarthritis. The hip joint and surrounding muscles have been shown to influence the amount of stress occurring at the knee joint during walking. In particular, the hip abductor muscles may have an effect on the knee joint by controlling the position of the pelvis and/or by acting as lateral stabilizers for the knee.
Research suggests that the function of the hip muscles during walking may be decreased in people with knee osteoarthritis and that greater loads may be placed on the knee joint as a result. Thus, interventions aimed at strengthening the hip abductor muscles may be effective for reducing stress on the arthritic knee and slowing the rate of progression of knee osteoarthritis.
The design of the study is a two-group pretest-posttest design using an untreated control group. Thirty-five individuals with medial compartment knee osteoarthritis will be recruited through newspaper advertisements and from the practices of orthopedic surgeons in Kingston, Ontario. Each participant with knee osteoarthritis will be matched with an asymptomatic volunteer for age (+/- 5 years), height (+/- 5 cm), mass (+/- 5 kg) and gender. Participants in the control group will have no clinical or radiographic diagnosis of knee or hip osteoarthritis or rheumatoid arthritis and no history of hip or knee trauma or pain.
- Conditions
- Osteoarthritis, Knee
- Being tested
- home exercise program for the hip abductor muscles
- Keywords
- osteoarthritis, knee, gait, muscle strength, hip, exercise
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home exercise program for the hip abductor musclesBehavioural
All patients with knee OA will be taught a home-based exercise program for the hip abductor muscles during the initial visit. Patients will be instructed in the following program: contraction of the gluteus medius muscle during functional activities (gait, stepping sideways up on a step and standing on one leg); and side lying isotonic hip abduction exercises using graded resistance elastic bands positioned around the distal thighs.
The program will be performed 3 times per week for 8 weeks and subjects will record exercise frequency and level of resistance on exercise calendars. Follow-up visits will occur at the end of week 1 and week 4 for review and progression of exercises. A telephone follow-up call will occur for support and participants will be encouraged to call with any questions or concerns.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Home-Based Program | Experimental | Patients with knee OA will be taught a home-based exercise program for the hip abductor muscles during the initial visit. The exercise program will be performed 3 times per week for 8 weeks. Receives: Behavioral: home exercise program for the hip abductor muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking variables: hip and knee abductor and adductor moments
Measured: baseline and after 8 weeks
Muscle strength measures: isometric and isokinetic peak torque measures for the hip abductor and adductor muscles
Measured: baseline and after 8 weeks
Secondary outcomes (4)
Radiographs: lower limb frontal plane alignment measures - limb alignment in degrees; grading of knee osteoarthritis severity (total score out of 13)
Measured: baseline
Speed of performance on the Five-Times-Sit-to-Stand Test
Measured: baseline and after 8 weeks
Total score on the WOMAC pain subscale and the WOMAC physical function subscale
Measured: baseline and after 8 weeks
Total score obtained for the physical activity scale (PASE)
Measured: baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionMay 2008
- Study completionSep 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 Osteoarthritis, KneeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Investigators
- Elsie G. Culham, PhD, Study director, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427843
- Sponsor's protocol ID
- REH-324-06
- Status last verified
- Oct 2008
- First submitted
- 25 Jan 2007
- Last updated
- 15 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sled EA, Khoja L, Deluzio KJ, Olney SJ, Culham EG. Effect of a home program of hip abductor exercises on knee joint loading, strength, function, and pain in people with knee osteoarthritis: a clinical trial. Phys Ther. 2010 Jun;90(6):895-904. doi: 10.2522/ptj.20090294. Epub 2010 Apr 8.
PubMed 20378679
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of a Home Program of Hip Abductor Exercises on Gait Parameters and Muscle Strength in Persons With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00427843
- Acronym / sponsor ID
- REH-324-06
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, knee, gait, muscle strength, hip, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 29 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 determine the influence of a home program of exercises for the hip muscles which support the pelvis on walking patterns and hip muscle strength in people with knee osteoarthritis. Following a hip muscle strengthening program, we hypothesize that participants with knee osteoarthritis will demonstrate decreased loading at the knee joint during walking and greater strength of the hip muscles.
Detailed description
Knee osteoarthritis is a common age-related impairment that may progress to cause significant pain and physical disability. Excessive loading at the knee joint is believed to contribute to the progression of knee osteoarthritis. The hip joint and surrounding muscles have been shown to influence the amount of stress occurring at the knee joint during walking. In particular, the hip abductor muscles may have an effect on the knee joint by controlling the position of the pelvis and/or by acting as lateral stabilizers for the knee.
Research suggests that the function of the hip muscles during walking may be decreased in people with knee osteoarthritis and that greater loads may be placed on the knee joint as a result. Thus, interventions aimed at strengthening the hip abductor muscles may be effective for reducing stress on the arthritic knee and slowing the rate of progression of knee osteoarthritis.
The design of the study is a two-group pretest-posttest design using an untreated control group. Thirty-five individuals with medial compartment knee osteoarthritis will be recruited through newspaper advertisements and from the practices of orthopedic surgeons in Kingston, Ontario. Each participant with knee osteoarthritis will be matched with an asymptomatic volunteer for age (+/- 5 years), height (+/- 5 cm), mass (+/- 5 kg) and gender. Participants in the control group will have no clinical or radiographic diagnosis of knee or hip osteoarthritis or rheumatoid arthritis and no history of hip or knee trauma or pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Home-Based Program | Experimental | Behavioral: home exercise program for the hip abductor musclesPatients with knee OA will be taught a home-based exercise program for the hip abductor muscles during the initial visit. The exercise program will be performed 3 times per week for 8 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age greater than or equal to 40 years
- self-reported pain in the knee(s) for most days of the month
- at least some difficulty in daily function due to knee osteoarthritis
- radiographic evidence of knee osteoarthritis or documented evidence of cartilage loss in the knee by arthroscopy surgery or magnetic resonance imaging.
Key exclusion criteria (6 listed)
- corticosteroid injection into either knee within the previous three months
- other significant medical problems (including significant heart disease, stroke and active treatment for cancer) that would prevent participants from being able to perform a hip exercise program or to participate in tests of walking performance and hip muscle strength
- known osteoarthritis or previous trauma affecting one or both hips
- previous replacement of any joint in the lower extremities.
- receiving rehabilitation services for knee osteoarthritis or performing a hip strengthening program at the time of testing
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 |
|---|---|---|
| home exercise program for the hip abductor musclesAll patients with knee OA will be taught a home-based exercise program for the hip abductor muscles during the initial visit. Patients will be instructed in the following program: contraction of the gluteus medius muscle during functional activities (gait, stepping sideways up on a step and standing on one leg); and side lying isotonic hip abduction exercises using graded resistance elastic bands positioned around the distal thighs. The program will be performed 3 times per week for 8 weeks and subjects will record exercise frequency and level of resistance on exercise calendars. Follow-up visits will occur at the end of week 1 and week 4 for review and progression of exercises. A telephone follow-up call will occur for support and participants will be encouraged to call with any questions or concerns. | Behavioural | Exercise Home-Based Program |
Primary outcome
Walking variables: hip and knee abductor and adductor moments
Time frame: baseline and after 8 weeks
Muscle strength measures: isometric and isokinetic peak torque measures for the hip abductor and adductor muscles
Time frame: baseline and after 8 weeks
4 secondary outcomes
Radiographs: lower limb frontal plane alignment measures - limb alignment in degrees; grading of knee osteoarthritis severity (total score out of 13)
Time frame: baseline
Speed of performance on the Five-Times-Sit-to-Stand Test
Time frame: baseline and after 8 weeks
Total score on the WOMAC pain subscale and the WOMAC physical function subscale
Time frame: baseline and after 8 weeks
Total score obtained for the physical activity scale (PASE)
Time frame: baseline and after 8 weeks
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 15 Oct 2008.
- Derived from this study: PubMed 20378679Sled EA, Khoja L, Deluzio KJ, Olney SJ, Culham EG. Effect of a home program of hip abductor exercises on knee joint loading, strength, function, and pain in people with knee osteoarthritis: a clinical trial. Phys Ther. 2010 Jun;90(6):895-904. doi: 10.2522/ptj.20090294. Epub 2010 Apr 8.
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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.
Elsie G. Culham, PhD study director
Queen's 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 home exercise program for the hip abductor muscles in people with Osteoarthritis, Knee, run by Queen's University at 1 site in Canada.
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 6 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 15 Oct 2008. 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 Canada. 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?
Walking variables: hip and knee abductor and adductor moments (time frame: baseline and after 8 weeks). The study lists 2 primary outcomes in all. 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 NCT00427843, 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 15 Oct 2008.