Degeneration; Articular Cartilage, KneeNCT02237911
Comparison of Treatments Following Total Knee Replacement
A study testing Clinic-based outpatient exercise group and Community-based exercise group in people with Degeneration; Articular Cartilage, Knee and Rheumatoid Arthritis, run by University of Pittsburgh at 1 site in United States.
Trial summary
Although total knee replacement (TKR) improves pain in numerous patients, it does not resolve many of the substantial functional limitations and physical inactivity that existed for a long time prior to the surgery. Exercise is an intervention that could improve these long-term limitations. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Degeneration; Articular Cartilage, Knee, Rheumatoid Arthritis, Osteoarthritis, Knee
- What is being tested?
- Clinic-based outpatient exercise group and Community-based exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 7 Sep 2017
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral TKR 2 to 4 months prior
- Older than 60 years of age
- Experience functional limitation in daily activities (score in WOMAC-PF of at least 9 points)
- Speak sufficient English to understand study instructions
- Have medical clearance to participate in the study
- Are willing to be randomized to one of the 3 treatment arms
Who cannot join
- Have absolute or relative contraindications to exercise
- Have history of uncontrolled cardiovascular disease or hypertension
- Are unable to walk 50 meters without an assistive device
- Have history of muscular or neurological disorder that affect lower extremity function
- Regular participation in exercise
- Terminal illness
- Planning to have another joint replacement during the next 12 months
- Plan not to be around during the next 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Physical Therapy, University of Pittsburgh
Pittsburgh, Pennsylvania, 15219
About this study
Official title: A Comparison of Treatment Methods for Patients Following Total Knee Replacement.
Although total knee replacement (TKR) improves pain in numerous patients, it does not resolve many of the substantial functional limitations and physical inactivity that existed for a long time prior to the surgery. Exercise is an intervention that could improve these long-term limitations. To promote these improvements, exercise should be implemented at later stage post TKR when patients can tolerate doses of exercise sufficiently high to promote substantial changes. To date, we just don't have enough good research to tell us which type of exercise works best for which patients and under which circumstances at later stage post TKR. This research study will provide evidence for recommended interventions during the later stage post TKR. The specific research questions are: (1) How do group exercise in the community and individual exercise in rehabilitation clinic compare with usual medical care on physical function and activity outcomes? (2) Who are the patients most likely to respond to each exercise intervention? (3) Are the approaches safe?
Read the detailed description
This is a comparative effectiveness study, designed as a 3-group single-blind randomized clinical trial. Two hundred forty older adults who underwent TKR at least 2 months prior and are otherwise eligible will be randomized into one of three treatment approaches: 1) clinic-based individual outpatient rehabilitative exercise; 2) community-based group exercise classes; or 3) usual medical care. Subjects will be treated for 3 months. Data will be collected before intervention, after intervention (3 months), and 6 months after randomization. Physical function is a primary outcome and will be assessed by the Western Ontario and McMaster Universities Arthritis Index and a battery of performance-based tests germane to patients post TKR that includes ability to walk, manage stairs, lift from the floor and the chair, and one-leg balance. We will also use an accelerometer-based monitor that provides a real-time measure of physical activity during normal daily living and is able to accurately capture most levels of activity. Linear mixed models will be fitted to compare the changes in outcome across groups. Logistic regression will identify patient characteristics that predict functional recovery in the exercise groups. Survival analysis and instrumental variable methods will be used to compare attrition, adherence and adverse events between groups.
- Being tested
- Clinic-based outpatient exercise group, Community-based exercise group
- Keywords
- total knee replacement, rehabilitation, exercise program, total knee arthroplasty
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinic-based outpatient exercise groupOther
Subjects will participate in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session will last about 60 minutes. Treatment sessions will utilize a pragmatic approach and will include the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills.
Community-based exercise groupOther
Subjects will attend to exercise classes (community-based) 2 times per week during 3 months. The exercise classes last approximately 60 minutes. The group exercise classes consists of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living.
| Study group | Role | What they receive |
|---|---|---|
| Clinic-based outpatient exercise group | Experimental | Subjects will participate in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session will last about 60 minutes. Treatment sessions will utilize a pragmatic approach and will include the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills. Receives: Other: Clinic-based outpatient exercise group |
| Community-based exercise group | Active comparator | Subjects will attend to exercise classes (community-based) 2 times per week during 3 months. The exercise classes last approximately 60 minutes. The group exercise classes consists of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living. Receives: Other: Community-based exercise group |
| Wait-listed usual medical care | No intervention | Wait-listed usual medical care - no intervention provided by study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Western Ontario and McMaster Universities Osteoarthritis Index Physical Function (WOMAC-PF).
WOMAC-PF is a patient reported outcome with 17 items. Each item is scored on a 5-point Likert-type Scale with descriptors from 0-4 (none, mild, moderate, severe, and extreme difficulty) and summed for a maximum score of 68. Higher scores indicate worse physical function.
Measured: Baseline, 3 and 6 months
Secondary outcomes (1)
Composite Score of Performed-based Tests of Physical Function.
Scores on 6 performance-based tests (i.e., the 6-minute walk test, 40-meter gait speed, stair ascend/descend test, single leg stance balance test, chair stand test, and floor sitting-rising) were combined into a composite score formed with the unit-weighted Z scores of constituent tests to provide a more representative and stable measure of the subjects' underlying functional performance. The unit weights refer to averaging standardized scores (e.g., the scores for each performance-based test are converted to Z-scores before applying equal weights). Higher Z-scores represent better functional performance. The Z-scores for each participant can be interpreted as deviations from the baseline average of the whole group. We considered a change in Z-score of 0.2 as clinically important because it represents approximately 20% of a standard deviation relative to the baseline average of the whole group.
Measured: Baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startDec 2014
- Primary completion7 Sep 2017
- Study completion7 Sep 2017
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 (2)Papers the sponsor has linked to this study.
- Other trials for Degeneration; Articular Cartilage, KneeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Sara R. Piva, University of Pittsburgh
- Investigators
- Sara R Piva, PT, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237911
- Sponsor's protocol ID
- PRO14080261
- Other IDs
- CER-1310-06994
- Status last verified
- Nov 2018
- First submitted
- 9 Sep 2014
- Last updated
- 11 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Piva SR, Schneider MJ, Moore CG, Catelani MB, Gil AB, Klatt BA, DiGioia AM, Almeida GJ, Khoja SS, Sowa G, Irrgang JJ. Effectiveness of Later-Stage Exercise Programs vs Usual Medical Care on Physical Function and Activity After Total Knee Replacement: A Randomized Clinical Trial. JAMA Netw Open. 2019 Feb 1;2(2):e190018. doi: 10.1001/jamanetworkopen.2019.0018.
PubMed 30794296Piva SR, Moore CG, Schneider M, Gil AB, Almeida GJ, Irrgang JJ. A randomized trial to compare exercise treatment methods for patients after total knee replacement: protocol paper. BMC Musculoskelet Disord. 2015 Oct 16;16:303. doi: 10.1186/s12891-015-0761-5.
PubMed 26474988
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Treatment Methods for Patients Following Total Knee Replacement.
- ClinicalTrials.gov ID
- NCT02237911
- Acronym / sponsor ID
- PRO14080261
- Keywords
- total knee replacement, rehabilitation, exercise program, total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Dec 2014
- Primary completion
- 7 Sep 2017 (actual)
- Study completion
- 7 Sep 2017 (actual)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Posted 11 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although total knee replacement (TKR) improves pain in numerous patients, it does not resolve many of the substantial functional limitations and physical inactivity that existed for a long time prior to the surgery. Exercise is an intervention that could improve these long-term limitations. To promote these improvements, exercise should be implemented at later stage post TKR when patients can tolerate doses of exercise sufficiently high to promote substantial changes. To date, we just don't have enough good research to tell us which type of exercise works best for which patients and under which circumstances at later stage post TKR. This research study will provide evidence for recommended interventions during the later stage post TKR. The specific research questions are: (1) How do group exercise in the community and individual exercise in rehabilitation clinic compare with usual medical care on physical function and activity outcomes? (2) Who are the patients most likely to respond to each exercise intervention? (3) Are the approaches safe?
Detailed description
This is a comparative effectiveness study, designed as a 3-group single-blind randomized clinical trial. Two hundred forty older adults who underwent TKR at least 2 months prior and are otherwise eligible will be randomized into one of three treatment approaches: 1) clinic-based individual outpatient rehabilitative exercise; 2) community-based group exercise classes; or 3) usual medical care. Subjects will be treated for 3 months. Data will be collected before intervention, after intervention (3 months), and 6 months after randomization. Physical function is a primary outcome and will be assessed by the Western Ontario and McMaster Universities Arthritis Index and a battery of performance-based tests germane to patients post TKR that includes ability to walk, manage stairs, lift from the floor and the chair, and one-leg balance. We will also use an accelerometer-based monitor that provides a real-time measure of physical activity during normal daily living and is able to accurately capture most levels of activity. Linear mixed models will be fitted to compare the changes in outcome across groups. Logistic regression will identify patient characteristics that predict functional recovery in the exercise groups. Survival analysis and instrumental variable methods will be used to compare attrition, adherence and adverse events between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinic-based outpatient exercise group | Experimental | Other: Clinic-based outpatient exercise groupSubjects will participate in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session will last about 60 minutes. Treatment sessions will utilize a pragmatic approach and will include the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills. |
| Community-based exercise group | Active comparator | Other: Community-based exercise groupSubjects will attend to exercise classes (community-based) 2 times per week during 3 months. The exercise classes last approximately 60 minutes. The group exercise classes consists of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living. |
| Wait-listed usual medical care | No intervention | –Wait-listed usual medical care - no intervention provided by study. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unilateral TKR 2 to 4 months prior
- Older than 60 years of age
- Experience functional limitation in daily activities (score in WOMAC-PF of at least 9 points)
- Speak sufficient English to understand study instructions
- Have medical clearance to participate in the study
Key exclusion criteria (8 listed)
- Have absolute or relative contraindications to exercise
- Have history of uncontrolled cardiovascular disease or hypertension
- Are unable to walk 50 meters without an assistive device
- Have history of muscular or neurological disorder that affect lower extremity function
- Regular participation in exercise
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 |
|---|---|---|
| Clinic-based outpatient exercise groupSubjects will participate in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session will last about 60 minutes. Treatment sessions will utilize a pragmatic approach and will include the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills. | Other | Clinic-based outpatient exercise group |
| Community-based exercise groupSubjects will attend to exercise classes (community-based) 2 times per week during 3 months. The exercise classes last approximately 60 minutes. The group exercise classes consists of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living. | Other | Community-based exercise group |
Primary outcome
The Western Ontario and McMaster Universities Osteoarthritis Index Physical Function (WOMAC-PF).
Time frame: Baseline, 3 and 6 months
WOMAC-PF is a patient reported outcome with 17 items. Each item is scored on a 5-point Likert-type Scale with descriptors from 0-4 (none, mild, moderate, severe, and extreme difficulty) and summed for a maximum score of 68. Higher scores indicate worse physical function.
1 secondary outcome
Composite Score of Performed-based Tests of Physical Function.
Time frame: Baseline, 3 and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30794296Piva SR, Schneider MJ, Moore CG, Catelani MB, Gil AB, Klatt BA, DiGioia AM, Almeida GJ, Khoja SS, Sowa G, Irrgang JJ. Effectiveness of Later-Stage Exercise Programs vs Usual Medical Care on Physical Function and Activity After Total Knee Replacement: A Randomized Clinical Trial. JAMA Netw Open. 2019 Feb 1;2(2):e190018. doi: 10.1001/jamanetworkopen.2019.0018.
- Derived from this study: PubMed 26474988Piva SR, Moore CG, Schneider M, Gil AB, Almeida GJ, Irrgang JJ. A randomized trial to compare exercise treatment methods for patients after total knee replacement: protocol paper. BMC Musculoskelet Disord. 2015 Oct 16;16:303. doi: 10.1186/s12891-015-0761-5.
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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.
Sara R Piva, PT, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinic-based outpatient exercise group and Community-based exercise group in people with Degeneration; Articular Cartilage, Knee and Rheumatoid Arthritis, 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 6 inclusion and 8 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 11 Mar 2019. 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 11 Mar 2019). 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?
The Western Ontario and McMaster Universities Osteoarthritis Index Physical Function (WOMAC-PF). (time frame: Baseline, 3 and 6 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 NCT02237911, which also lists 2 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 11 Mar 2019.