OsteoarthritisPROGNCT01537328
Progressive Rehabilitation Following Total Knee Arthroplasty
A study testing Total knee replacement rehabilitation in people with Osteoarthritis, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of a progressive resistance rehabilitation program (PROG) after total knee arthroplasty (TKA) compared to a traditional rehabilitation program (TRAD). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Total knee replacement rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jun 2018
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing a primary, unilateral knee arthroplasty
- body mass index < 40 kg/m2
Who cannot join
- severe contralateral leg OA (< 5/10 pain with stair climbing) or other unstable orthopaedic conditions that limit function
- neurological conditions that affect muscle function
- vascular or cardiac problems that limit function
- uncontrolled diabetes
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effectiveness of a progressive resistance rehabilitation program (PROG) after total knee arthroplasty (TKA) compared to a traditional rehabilitation program (TRAD).
The investigators hypothesized:
- PROG will result in greater improvements in functional outcome measures such as: stair climbing test (SCT), timed-up-and-go test (TUG), six minute walk test (6MW), the Knee Injury and Osteoarthritis Outcome Survey (WOMAC), and knee range of motion (ROM).
- PROG will result in greater improvements in quadriceps muscle strength gains after TKA compared to TRAD.
- PROG will result in greater improvements in muscle mass and central activation compared to TRAD.
Read the detailed description
Over 500,000 total knee arthroplasties (TKAs) are performed each year in the United States to alleviate pain and disability associated with knee osteoarthritis (OA), and this number is expected to grow to 3.48 million per year by the year 2030. TKA reduces pain and improves self-reported function compared to pre-operative levels, but post-operative deficits in walking speed (20% slower) and stair climbing speed (50% slower) can persist for years. Stair climbing performance is the single largest residual deficit after TKA with seventy-five percent of TKA patients reporting difficulty negotiating stairs after surgery. Collectively, these findings suggest that current rehabilitation does not adequately target the impairments that lead to long-term deficits in functional mobility after TKA.
The aim of the proposed trial is to evaluate the effectiveness of a progressive resistance rehabilitation program (PROG) after TKA compared to a traditional rehabilitation program (TRAD). The PROG intervention will involve intensive rehabilitation using progressive resistance exercise and faster progression to functional strengthening exercises. The TRAD intervention represents the synthesis of previously published TKA rehabilitation programs. Our preliminary data suggest that the PROG intervention has low risk and results in improved functional mobility and muscle strength. The investigators will measure function and strength at six time points (pre-op; 1, 2, 3, 6, and 12 months after TKA). The investigators will also evaluate the contribution of changes in muscle mass (atrophy/hypertrophy) and central activation to changes in muscle strength following PROG and TRAD interventions.
- Conditions
- Osteoarthritis
- Being tested
- Total knee replacement rehabilitation
- Keywords
- Total knee arthroplasty, quadriceps, muscle, arthroplasty, joint diseases, musculoskeletal diseases
- Medical subject headings
- Osteoarthritis, Joint Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee replacement rehabilitationOther
After total knee arthroplasty, patients will be assigned to an outpatient rehabilitation clinic, based upon geography. Patients will be enrolled randomly into one of two rehabilitation programs (PROG or TRAD). Both rehabilitation programs will take place over 12 weeks. Both groups will receive treatment for range of motion, activities of daily living and gait training, as well as a home exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Treatment | Experimental | Progressive intervention will involve the early initiation of intensive rehabilitation using progressive exercise and faster progression to functional strengthening exercises. Receives: Other: Total knee replacement rehabilitation |
| Traditional treatment | Active comparator | Traditional intervention represents the synthesis of previously published total knee arthroplasty rehabilitation programs. Receives: Other: Total knee replacement rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Stair climbing test (SCT)
Time to ascend and descend one flight of stairs
Measured: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
Secondary outcomes (5)
Change from baseline in Timed-up-and-go Test (TUG)
Measured: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
Change from baseline in 6-minute walk test (6MW)
Measured: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
Change from baseline in muscle strength
Isometric quadriceps and hamstrings strength.
Measured: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
Change from baseline in self-reported health status
WOMAC and SF-12
Measured: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
Change from baseline in muscle activation
Doublet interpolation for quadriceps activation.
Measured: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startJul 2011
- Primary completionMay 2016
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Colorado, DenverThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Jennifer Stevens-Lapsley, MPT, PHD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537328
- Sponsor's protocol ID
- 10-1188
- Other IDs
- R01HD065900
- Acronym
- PROG
- Status last verified
- Oct 2018
- First submitted
- 26 Aug 2011
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Bade M, Struessel T, Paxton R, Winters J, Baym C, Stevens-Lapsley J. Performance on a Clinical Quadriceps Activation Battery Is Related to a Laboratory Measure of Activation and Recovery After Total Knee Arthroplasty. Arch Phys Med Rehabil. 2018 Jan;99(1):99-106. doi: 10.1016/j.apmr.2017.07.013. Epub 2017 Aug 31.
PubMed 28864244Bade MJ, Struessel T, Dayton M, Foran J, Kim RH, Miner T, Wolfe P, Kohrt WM, Dennis D, Stevens-Lapsley JE. Early High-Intensity Versus Low-Intensity Rehabilitation After Total Knee Arthroplasty: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2017 Sep;69(9):1360-1368. doi: 10.1002/acr.23139. Epub 2017 Aug 13.
PubMed 27813347
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Rehabilitation Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01537328
- Acronym / sponsor ID
- PROG / 10-1188
- Conditions
- Osteoarthritis
- Keywords
- Total knee arthroplasty, quadriceps, muscle, arthroplasty, joint diseases, musculoskeletal diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jul 2011
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 23 Feb 2012 (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 evaluate the effectiveness of a progressive resistance rehabilitation program (PROG) after total knee arthroplasty (TKA) compared to a traditional rehabilitation program (TRAD).
The investigators hypothesized:
- PROG will result in greater improvements in functional outcome measures such as: stair climbing test (SCT), timed-up-and-go test (TUG), six minute walk test (6MW), the Knee Injury and Osteoarthritis Outcome Survey (WOMAC), and knee range of motion (ROM).
- PROG will result in greater improvements in quadriceps muscle strength gains after TKA compared to TRAD.
- PROG will result in greater improvements in muscle mass and central activation compared to TRAD.
Detailed description
Over 500,000 total knee arthroplasties (TKAs) are performed each year in the United States to alleviate pain and disability associated with knee osteoarthritis (OA), and this number is expected to grow to 3.48 million per year by the year 2030. TKA reduces pain and improves self-reported function compared to pre-operative levels, but post-operative deficits in walking speed (20% slower) and stair climbing speed (50% slower) can persist for years. Stair climbing performance is the single largest residual deficit after TKA with seventy-five percent of TKA patients reporting difficulty negotiating stairs after surgery. Collectively, these findings suggest that current rehabilitation does not adequately target the impairments that lead to long-term deficits in functional mobility after TKA.
The aim of the proposed trial is to evaluate the effectiveness of a progressive resistance rehabilitation program (PROG) after TKA compared to a traditional rehabilitation program (TRAD). The PROG intervention will involve intensive rehabilitation using progressive resistance exercise and faster progression to functional strengthening exercises. The TRAD intervention represents the synthesis of previously published TKA rehabilitation programs. Our preliminary data suggest that the PROG intervention has low risk and results in improved functional mobility and muscle strength. The investigators will measure function and strength at six time points (pre-op; 1, 2, 3, 6, and 12 months after TKA). The investigators will also evaluate the contribution of changes in muscle mass (atrophy/hypertrophy) and central activation to changes in muscle strength following PROG and TRAD interventions.
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 |
|---|---|---|
| Progressive Treatment | Experimental | Other: Total knee replacement rehabilitationProgressive intervention will involve the early initiation of intensive rehabilitation using progressive exercise and faster progression to functional strengthening exercises. |
| Traditional treatment | Active comparator | Other: Total knee replacement rehabilitationTraditional intervention represents the synthesis of previously published total knee arthroplasty rehabilitation programs. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- undergoing a primary, unilateral knee arthroplasty
- body mass index < 40 kg/m2
Key exclusion criteria (5 listed)
- severe contralateral leg OA (< 5/10 pain with stair climbing) or other unstable orthopaedic conditions that limit function
- neurological conditions that affect muscle function
- vascular or cardiac problems that limit function
- uncontrolled diabetes
- pregnancy
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 |
|---|---|---|
| Total knee replacement rehabilitationAfter total knee arthroplasty, patients will be assigned to an outpatient rehabilitation clinic, based upon geography. Patients will be enrolled randomly into one of two rehabilitation programs (PROG or TRAD). Both rehabilitation programs will take place over 12 weeks. Both groups will receive treatment for range of motion, activities of daily living and gait training, as well as a home exercise program. | Other | Progressive Treatment, Traditional treatment |
Primary outcome
Change from baseline in Stair climbing test (SCT)
Time frame: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
Time to ascend and descend one flight of stairs
5 secondary outcomes
Change from baseline in Timed-up-and-go Test (TUG)
Time frame: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
Change from baseline in 6-minute walk test (6MW)
Time frame: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
Change from baseline in muscle strength
Time frame: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
Change from baseline in self-reported health status
Time frame: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
Change from baseline in muscle activation
Time frame: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 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 11 Oct 2018.
- Derived from this study: PubMed 28864244Bade M, Struessel T, Paxton R, Winters J, Baym C, Stevens-Lapsley J. Performance on a Clinical Quadriceps Activation Battery Is Related to a Laboratory Measure of Activation and Recovery After Total Knee Arthroplasty. Arch Phys Med Rehabil. 2018 Jan;99(1):99-106. doi: 10.1016/j.apmr.2017.07.013. Epub 2017 Aug 31.
- Derived from this study: PubMed 27813347Bade MJ, Struessel T, Dayton M, Foran J, Kim RH, Miner T, Wolfe P, Kohrt WM, Dennis D, Stevens-Lapsley JE. Early High-Intensity Versus Low-Intensity Rehabilitation After Total Knee Arthroplasty: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2017 Sep;69(9):1360-1368. doi: 10.1002/acr.23139. Epub 2017 Aug 13.
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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.
Jennifer Stevens-Lapsley, MPT, PHD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee replacement rehabilitation in people with Osteoarthritis, run by University of Colorado, Denver 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 5 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 Oct 2018. 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?
Change from baseline in Stair climbing test (SCT) (time frame: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 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 NCT01537328, 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 Oct 2018.