OsteoarthritisPhase 2NCT00078624
Knee Stability Training for Knee Osteoarthritis (OA)
A Phase 2 study testing Traditional exercise therapy for knee osteoarthritis and Knee stability training in people with Osteoarthritis and Joint Diseases, run by University of Pittsburgh at 1 site in United States.
Trial summary
People with knee osteoarthritis (OA) frequently complain of knee instability. This study will test whether certain exercises can improve knee stability, reduce pain, and improve physical function in people with knee OA. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Joint Diseases
- What is being tested?
- Traditional exercise therapy for knee osteoarthritis and Knee stability training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Dec 2008
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the 1986 American College of Rheumatology (ACR) clinical criteria for knee osteoarthritis
- Grade II or greater Kellgren and Lawrence radiographic changes
Who cannot join
- History of two or more falls within the year prior to study entry
- Unable to walk a distance of 100 feet without an assistive device or a rest period
- Total knee arthroplasty
- Uncontrolled hypertension
- History of cardiovascular disease
- History of neurological disorders that affect lower extremity function such as stroke or peripheral neuropathy
Show all 9Show fewer
- Corticosteroid injection to the quadriceps or patellar tendon in the past month, or 3 or more within the past year
- Quadriceps tendon rupture, patellar tendon rupture, or patellar fracture that could place them at risk of re-injury during quadriceps strength testing
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Knee Stability Training in Individuals With Knee Osteoarthritis
People with knee osteoarthritis (OA) frequently complain of knee instability. This study will test whether certain exercises can improve knee stability, reduce pain, and improve physical function in people with knee OA.
Study hypotheses: 1) Participants in the stability training group will demonstrate less pain and higher levels of physical function, based on self-report measures of pain and function (WOMAC, Lower Extremity Function Scale), and less time to complete the Get Up and Go test, a physical performance measure of function. 2) During walking and the step down task, participants in the stability training group will demonstrate greater knee motion during weight bearing, greater vertical ground reaction forces and loading rates, and reduced ratios of co-contraction between quadriceps/hamsting and tibialis anterior/gastrocnemius muscle pairs compared to the standard group. Participants in the stability group will also demonstrate greater step lengths, single limb support times, and average walking velocity compared to the standard group.
Read the detailed description
Traditional exercise therapy for knee OA primarily focuses on lower limb strength and joint motion deficits. Recent evidence has suggested that changes in lower limb biomechanical factors during weight bearing activities may have substantial impact on physical function and disease progression in individuals with knee OA. The effectiveness of exercise therapy programs might be improved by incorporating balance and agility training techniques (knee stability training). The aim of this trial is to test the effectiveness of supplementing traditional exercise therapy with knee stability training techniques tailored for individuals with knee OA.
Participants will be randomly assigned to one of two groups. The first group will participate in a standard rehabilitation program of traditional exercise therapy for knee OA. The second group will participate in a standard rehabilitation program supplemented with a knee stability program. Study visits will occur at study entry, 2 months, 6 months, and 1 year. At each study visit, changes in pain, physical function, and biomechanical factors will be assessed. This study will last for one year.
- Conditions
- Osteoarthritis, Joint Diseases
- Being tested
- Traditional exercise therapy for knee osteoarthritis, Knee stability training
- Keywords
- Osteoarthritis, Knee Joint, Joint Stability, Motor Control, Exercise Therapy
- Medical subject headings
- Osteoarthritis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional exercise therapy for knee osteoarthritisOther
Exercises include stretching, strengthening, and aerobic exercise
Knee stability trainingOther
The addition of agility and perturbation training techniques to the traditional exercise program
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Traditional exercise program supplemented with knee stability training activities Receives: Other: Knee stability training |
| 2 | Active comparator | Traditional exercise program Receives: Other: Traditional exercise therapy for knee osteoarthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster OA index (WOMAC)
Measured: Measured at baseline, 2 months, 6 months, 1 year
Lower Extremity Function Scale
Measured: Measured at baseline, 2 months, 6 months, 1 year
Get Up and Go test (a physical performance measure of function)
Measured: Measured at baseline, 2 months, 6 months
Knee Outcome Survey - Activities of Daily Living Scale
Measured: Measured at baseline, 2 months, 6 months, 1 year
Secondary outcomes (8)
Cartilage morphology changes as measured by MRI
Measured: Measured at baseline, 1 year
Physical Activity Scale for the Elderly
Measured: Measured at baseline, 2 months, 6 months, 1 year
Quadriceps strength and activation
Measured: Measured at baseline, 2 months, 6 months
Radiographic severity of OA
Measured: Measured at baseline, 1 year
Fear Avoidance questionnaire for the knee
Measured: Measured at baseline, 2months, 6 months, 1 year
Beck Anxiety Index
Measured: Measured at baseline, 2 months, 6 months, 1 year
Center for Epidemiological Studies Depression Scale
Measured: Measured at baseline, 2 months, 6 months, 1 year
Motion analysis variables (knee motion, vertical ground reaction force, loading rates, knee adduction/abduction moment, and lower extremity muscle co-contractions during walking and a step-down task)
Measured: Measured at baseline, 2 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2004 (estimated)
- Study startApr 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 PittsburghThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- G. Kelley Fitzgerald, PhD, PT, Principal investigator, University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078624
- Sponsor's protocol ID
- NIAMS-117
- Other IDs
- R01AR048760-01A2
- Status last verified
- Jan 2013
- First submitted
- 3 Mar 2004
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Fitzgerald GK, White DK, Piva SR. Associations for change in physical and psychological factors and treatment response following exercise in knee osteoarthritis: an exploratory study. Arthritis Care Res (Hoboken). 2012 Nov;64(11):1673-80. doi: 10.1002/acr.21751.
PubMed 22674892Teixeira PE, Piva SR, Fitzgerald GK. Effects of impairment-based exercise on performance of specific self-reported functional tasks in individuals with knee osteoarthritis. Phys Ther. 2011 Dec;91(12):1752-65. doi: 10.2522/ptj.20100269. Epub 2011 Oct 14.
PubMed 22003157Fitzgerald GK, Piva SR, Gil AB, Wisniewski SR, Oddis CV, Irrgang JJ. Agility and perturbation training techniques in exercise therapy for reducing pain and improving function in people with knee osteoarthritis: a randomized clinical trial. Phys Ther. 2011 Apr;91(4):452-69. doi: 10.2522/ptj.20100188. Epub 2011 Feb 17.
PubMed 21330451
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knee Stability Training in Individuals With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00078624
- Acronym / sponsor ID
- NIAMS-117
- Conditions
- Osteoarthritis, Joint Diseases
- Keywords
- Osteoarthritis, Knee Joint, Joint Stability, Motor Control, Exercise Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Apr 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 Mar 2004 (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.
People with knee osteoarthritis (OA) frequently complain of knee instability. This study will test whether certain exercises can improve knee stability, reduce pain, and improve physical function in people with knee OA.
Study hypotheses: 1) Participants in the stability training group will demonstrate less pain and higher levels of physical function, based on self-report measures of pain and function (WOMAC, Lower Extremity Function Scale), and less time to complete the Get Up and Go test, a physical performance measure of function. 2) During walking and the step down task, participants in the stability training group will demonstrate greater knee motion during weight bearing, greater vertical ground reaction forces and loading rates, and reduced ratios of co-contraction between quadriceps/hamsting and tibialis anterior/gastrocnemius muscle pairs compared to the standard group. Participants in the stability group will also demonstrate greater step lengths, single limb support times, and average walking velocity compared to the standard group.
Detailed description
Traditional exercise therapy for knee OA primarily focuses on lower limb strength and joint motion deficits. Recent evidence has suggested that changes in lower limb biomechanical factors during weight bearing activities may have substantial impact on physical function and disease progression in individuals with knee OA. The effectiveness of exercise therapy programs might be improved by incorporating balance and agility training techniques (knee stability training). The aim of this trial is to test the effectiveness of supplementing traditional exercise therapy with knee stability training techniques tailored for individuals with knee OA.
Participants will be randomly assigned to one of two groups. The first group will participate in a standard rehabilitation program of traditional exercise therapy for knee OA. The second group will participate in a standard rehabilitation program supplemented with a knee stability program. Study visits will occur at study entry, 2 months, 6 months, and 1 year. At each study visit, changes in pain, physical function, and biomechanical factors will be assessed. This study will last for one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Knee stability trainingTraditional exercise program supplemented with knee stability training activities |
| 2 | Active comparator | Other: Traditional exercise therapy for knee osteoarthritisTraditional exercise program |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meet the 1986 American College of Rheumatology (ACR) clinical criteria for knee osteoarthritis
- Grade II or greater Kellgren and Lawrence radiographic changes
Key exclusion criteria (9 listed)
- History of two or more falls within the year prior to study entry
- Unable to walk a distance of 100 feet without an assistive device or a rest period
- Total knee arthroplasty
- Uncontrolled hypertension
- History of cardiovascular disease
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 |
|---|---|---|
| Traditional exercise therapy for knee osteoarthritisExercises include stretching, strengthening, and aerobic exercise | Other | 2 |
| Knee stability trainingThe addition of agility and perturbation training techniques to the traditional exercise program | Other | 1 |
Primary outcome
Western Ontario and McMaster OA index (WOMAC)
Time frame: Measured at baseline, 2 months, 6 months, 1 year
Lower Extremity Function Scale
Time frame: Measured at baseline, 2 months, 6 months, 1 year
Get Up and Go test (a physical performance measure of function)
Time frame: Measured at baseline, 2 months, 6 months
Knee Outcome Survey - Activities of Daily Living Scale
Time frame: Measured at baseline, 2 months, 6 months, 1 year
8 secondary outcomes
Cartilage morphology changes as measured by MRI
Time frame: Measured at baseline, 1 year
Physical Activity Scale for the Elderly
Time frame: Measured at baseline, 2 months, 6 months, 1 year
Quadriceps strength and activation
Time frame: Measured at baseline, 2 months, 6 months
Radiographic severity of OA
Time frame: Measured at baseline, 1 year
Fear Avoidance questionnaire for the knee
Time frame: Measured at baseline, 2months, 6 months, 1 year
Beck Anxiety Index
Time frame: Measured at baseline, 2 months, 6 months, 1 year
Center for Epidemiological Studies Depression Scale
Time frame: Measured at baseline, 2 months, 6 months, 1 year
Motion analysis variables (knee motion, vertical ground reaction force, loading rates, knee adduction/abduction moment, and lower extremity muscle co-contractions during walking and a step-down task)
Time frame: Measured at baseline, 2 months, 6 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 24 Jan 2013.
- Derived from this study: PubMed 22674892Fitzgerald GK, White DK, Piva SR. Associations for change in physical and psychological factors and treatment response following exercise in knee osteoarthritis: an exploratory study. Arthritis Care Res (Hoboken). 2012 Nov;64(11):1673-80. doi: 10.1002/acr.21751.
- Derived from this study: PubMed 22003157Teixeira PE, Piva SR, Fitzgerald GK. Effects of impairment-based exercise on performance of specific self-reported functional tasks in individuals with knee osteoarthritis. Phys Ther. 2011 Dec;91(12):1752-65. doi: 10.2522/ptj.20100269. Epub 2011 Oct 14.
- Derived from this study: PubMed 21330451Fitzgerald GK, Piva SR, Gil AB, Wisniewski SR, Oddis CV, Irrgang JJ. Agility and perturbation training techniques in exercise therapy for reducing pain and improving function in people with knee osteoarthritis: a randomized clinical trial. Phys Ther. 2011 Apr;91(4):452-69. doi: 10.2522/ptj.20100188. Epub 2011 Feb 17.
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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.
G. Kelley Fitzgerald, PhD, PT principal investigator
University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Traditional exercise therapy for knee osteoarthritis and Knee stability training in people with Osteoarthritis and Joint Diseases, run by University of Pittsburgh 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 2 inclusion and 9 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 Jan 2013. 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.
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?
Western Ontario and McMaster OA index (WOMAC) (time frame: Measured at baseline, 2 months, 6 months, 1 year). The study lists 4 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 NCT00078624, which also lists 3 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 24 Jan 2013.