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| ID | Type | Description | Link |
|---|---|---|---|
| CER-1310-06994 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Wait-listed usual medical care | No Intervention | Wait-listed usual medical care - no intervention provided by study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinic-based outpatient exercise group | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity Energy Expenditure - Measured by Portable Activity Monitor (SenseWear). | Real-time measure of daily energy expenditure physical activity assessed by portable activity monitor. | Baseline, 3 and 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara R Piva, PT, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physical Therapy, University of Pittsburgh | Pittsburgh | Pennsylvania | 15219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30794296 | Derived | 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. | |
| 26474988 |
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A total of 1372 subjects called for study information: 89 could not be contacted and 1283 were screened over the telephone. From those, 1032 were not eligible/willing to participate and 251 completed in-person screening. Eleven subjects failed in-person screening, resulting in 240 eligible subjects that were randomized into one of the study arms.
Potential subjects were identified from their surgeons' office or via public announcement in the greater Pittsburgh area, from December 2014 through February 2017. If interested in the study, subjects called the research team to obtain more information about the study, and were then screened for study eligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clinic-based Outpatient Exercise Group | Subjects participated in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session lasted about 60 minutes. Treatment sessions utilized a pragmatic approach and included the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills. |
| FG001 | Community-based Exercise Group | Subjects attended to exercise classes (community-based) 2 times per week during 3 months. The exercise classes lasted approximately 60 minutes. The group exercise classes consisted of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living. |
| FG002 | Wait-listed Usual Medical Care | Wait-listed usual medical care - no intervention provided by study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clinic-based Outpatient Exercise Group | Subjects participated in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session lasted about 60 minutes. Treatment sessions utilized a pragmatic approach and included exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention-to-treat approach was used among participants with follow-up data. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 and 6 months |
|
The adverse events were collected during subjects participation in the study (over 6 months).
The study used a standard questionnaire to monitor AEs every 1.5 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clinic-based Outpatient Exercise Group | Clinic-based outpatient exercise group: Subjects participated in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session lasted about 60 minutes. Treatment sessions utilized 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sara Piva | University of Pittsburgh | (412) 383-6712 | spiva@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2014 | Nov 15, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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|
| Community-based exercise group | Other | 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. |
|
| Baseline, 3 and 6 months |
| Piva 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. |
| BG001 | Community-based Exercise Group | Subjects attended to exercise classes (community-based) 2 times per week during 3 months. The exercise classes lasted approximately 60 minutes. The group exercise classes consisted of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living. |
| BG002 | Wait-listed Usual Medical Care | Wait-listed usual medical care - no intervention provided by study. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Cumulative Illness Rating Scale | Mean | Standard Deviation | Number of comorbidities |
|
| Total Knee Replacement Due To | Count of Participants | Participants |
|
| Surgical Knee Flexion | Mean | Standard Deviation | degrees |
|
| Surgical knee pain | Numeric Pain Rating Scale (NPRS). Current pain intensity was measure by NRPS. Score ranged from 0 to 10, 0 representing no pain, and 10 representing worse pain imaginable. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Community-based Exercise Group | Community-based exercise group: Subjects attended to exercise classes (community-based) 2 times per week during 3 months. The exercise classes lasted 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. |
| OG002 | Wait-listed Usual Medical Care | Wait-listed usual medical care - no intervention provided by study. |
|
|
|
| Secondary | 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. | Intention-to-treat approach was used among participants with follow-up data. | Posted | Mean | Standard Deviation | Z-score | Baseline, 3 and 6 months |
|
|
|
|
| Other Pre-specified | Physical Activity Energy Expenditure - Measured by Portable Activity Monitor (SenseWear). | Real-time measure of daily energy expenditure physical activity assessed by portable activity monitor. | Intention-to-treat approach was used among participants with follow-up data. | Posted | Mean | Standard Deviation | Kcal/day | Baseline, 3 and 6 months |
|
|
|
|
| 0 |
| 96 |
| 5 |
| 96 |
| 39 |
| 96 |
| EG001 | Community-based Exercise Group | Community-based exercise group: Subjects attended to exercise classes (community-based) 2 times per week during 3 months. The exercise classes lasted 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. | 0 | 96 | 4 | 96 | 42 | 96 |
| EG002 | Wait-listed Usual Medical Care | Wait-listed usual medical care - no intervention provided by study. | 0 | 48 | 5 | 48 | 22 | 48 |
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal Disorders | Gastrointestinal disorders | Systematic Assessment |
|
| Injury, poisoning and procedural complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Sleep apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Surgical and medical procedures | Surgical and medical procedures | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| Wound infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Other musculoskeletal and connective tissue disorder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cataract | Eye disorders | Systematic Assessment |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010003 | Osteoarthritis |
| 3 months |
|
|
| 6 months |
|
|
Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion). |
| 0.012 |
| Mean Difference (Final Values) |
| 0.2 |
| 2-Sided |
| 98.3 |
| 0.01 |
| 0.4 |
| Superiority |
| Mixed Models Analysis | Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion). | 0.005 | Mean Difference (Final Values) | 0.2 | 2-Sided | 98.3 | 0.02 | 0.3 | Superiority |
| Mixed Models Analysis | Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion). | 0.052 | Mean Difference (Final Values) | 0.2 | 2-Sided | 98.3 | -0.003 | 0.3 | Superiority |
| Mixed Models Analysis | Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion). | 0.015 | Mean Difference (Final Values) | 0.2 | 2-Sided | 98.3 | 0.02 | 0.3 | Superiority |
| Mixed Models Analysis | Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion). | 0.489 | Mean Difference (Final Values) | 0.02 | 2-Sided | 98.3 | -0.003 | 0.3 | Superiority |
| 3 months |
|
|
| 6 months |
|
|
Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion). |
| 0.814 |
| Mean Difference (Final Values) |
| 15 |
| 2-Sided |
| 95 |
| -112 |
| 142 |
| Superiority |
| Mixed Models Analysis | Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion). | 0.787 | Mean Difference (Final Values) | -15 | 2-Sided | 95 | -125 | 95 | Superiority |
| Mixed Models Analysis | Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion). | 0.581 | Mean Difference (Final Values) | -36 | 2-Sided | 95 | -164 | 92 | Superiority |
| Mixed Models Analysis | Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion). | 0.676 | Mean Difference (Final Values) | 19 | 2-Sided | 95 | -71 | 109 | Superiority |
| Mixed Models Analysis | Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion). | 0.330 | Mean Difference (Final Values) | 51 | 2-Sided | 95 | -52 | 154 | Superiority |