Osteoarthritis, Total Knee Arthroplasty
Conditions
Keywords
Rehabilitation, Total Knee Arthroplasty, Telemedicine, Physical Activity
Brief summary
Although total knee arthroplasty is an effective intervention for decreasing knee pain and improving physical function, physical activity levels remain low up to a year after surgery. This study will use mobile-health technology to deliver an intervention designed to improve physical activity behavior for Veterans recovering from total knee arthroplasty. The study will assess the effectiveness of using behavior-change intervention as a supplement to conventional rehabilitation to improve physical activity. The intervention will be delivered using home-based tablet computers for Veterans to have remote interaction with the researcher and real-time physical activity feedback from a wrist-worn activity sensor.
Detailed description
This randomized clinical trial will assess the efficacy of using physical activity behavior change intervention for Veterans recovering from total knee arthroplasty. Testing will occur at baseline (before surgery), at intervention midpoint (8 weeks after surgery), end of intervention (14 weeks after surgery), and 24 weeks after intervention. The primary outcome is accelerometer-assessed daily step count. Secondary outcomes include the percent time engaged in standing and walking activity and physical function (Six-Minute Walk, 30-Second Chair-Stand Test, Timed Up-and-Go, Western Ontario and McMaster Universities Osteoarthritis Index, and the Veterans RAND 12-Item Health Survey.
Interventions
BEHAVIORALPhysical Activity Behavior Intervention
Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
OTHERAttention Control
Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized controlled trial; Two groups.
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Veteran * Planned unilateral total knee arthroplasty
Exclusion criteria
* Severe non-surgical limb pain (pain \>5/10 on non-surgical limb with walking) * Unstable orthopedic, neurologic, or pulmonary condition that limits function * Unstable cardiac condition * Uncontrolled hypertension * Uncontrolled diabetes * Acute systemic infection * Active cancer treatment * Recent stroke (within 2 years)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Free-living Daily Step Count | End of intervention (14 weeks) | Accelerometer-based measurement of free-living daily step count |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-Second Chair-Stand Test W38 | 24 weeks after intervention (week 38 of study) | Physical function test that assesses the number of sit-stand-sit transitions that a participant performs in the span of 30 seconds. |
| 30-Second Chair-Stand Test W14 | End of intervention (14 weeks) | Physical function test that assesses the number of sit-stand-sit transitions that a participant performs in the span of 30 seconds. |
| Six-Minute Walk Test W38 | 24 weeks after intervention (week 38 of study) | Physical function test measuring the total distance walked in a span of six minutes. |
| Timed Up-and-Go Test W14 | End of intervention (14 weeks) | A physical performance measure that includes rising from a chair, walking 3 meters, turning 180 degrees, returning to chair, and sitting. |
| Timed Up-and-Go Test W38 | 24 weeks after intervention (week 38 of study) | A physical performance measure that includes rising from a chair, walking 3 meters, turning 180 degrees, returning to chair, and sitting. |
| Western Ontario and McMaster Universities Osteoarthritis Index W14 | End of intervention (14 weeks) | Self-report health status measure of pain, stiffness, and function for people with osteoarthritis of the hip or knee. A higher score indicates worse outcome with the Total Score range from 0-96. A positive change indicates worse outcome and a negative change indicates a better outcome across time points. |
| Six-Minute Walk Test W14 | End of intervention (14 weeks) | Physical function test measuring the total distance walked in a span of six minutes. |
| Veterans RAND 12-Item Health Survey Physical Component W14 | End of intervention (14 weeks) | A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. |
| Veterans RAND 12-Item Health Survey Physical Component W38 | 24 weeks after intervention (week 38 of study) | A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. |
| Veterans RAND 12-Item Health Survey Mental Component W14 | End of intervention (14 weeks) | A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. |
| Veterans RAND 12-Item Health Survey Mental Component W38 | 24 weeks after intervention (week 38 of study) | A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. |
| Free-living Daily Step Count W38 | 24 weeks after intervention (week 38 of study) | Accelerometer-based measurement of free-living daily step count |
| Western Ontario and McMaster Universities Osteoarthritis Index W38 | 24 weeks after intervention (week 38 of the study) | Self-report health status measure of pain, stiffness, and function for people with osteoarthritis of the hip or knee. A higher score indicates worse outcome with the Total Score range from 0-96. A positive change indicates worse outcome and a negative change indicates a better outcome across time points. |
Countries
United States
Participant flow
Recruitment details
114 participants were enrolled in the study. There were n=22 participants lost to follow-up before randomization: n=14 post-consent screen fail, n=7 withdrew, and n=1 no valid baseline activity data. n=92 participants were randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| Physical Activity Behavior Intervention A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement.
Physical Activity Behavior Intervention: Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning. | 46 |
| Attention Control Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions. | 46 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Physical Activity Behavior Intervention | Attention Control | Total |
|---|---|---|---|
| Age, Continuous | 68 years | 68 years | 68 years |
| Education Bachelor or Associate Degree | 22 Participants | 21 Participants | 43 Participants |
| Education < High School / High School | 15 Participants | 20 Participants | 35 Participants |
| Education Master's or Professional Degree | 7 Participants | 4 Participants | 11 Participants |
| Education Missing | 1 Participants | 0 Participants | 1 Participants |
| Education Other | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 12 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 32 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized African-American | 7 Participants | 4 Participants | 11 Participants |
| Race/Ethnicity, Customized Caucasian | 38 Participants | 39 Participants | 77 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 8 Participants | 3 Participants | 11 Participants |
| Sex: Female, Male Male | 38 Participants | 43 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 46 |
| other Total, other adverse events | 33 / 46 | 43 / 46 |
| serious Total, serious adverse events | 3 / 46 | 8 / 46 |
Outcome results
Primary
Free-living Daily Step Count
Accelerometer-based measurement of free-living daily step count
Time frame: End of intervention (14 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity Behavior Intervention | Free-living Daily Step Count | 6947 step count |
| Attention Control | Free-living Daily Step Count | 6339 step count |
p-value: 0.02495% CI: [41.65, 1819.36]Mixed Models Analysis
Secondary
30-Second Chair-Stand Test W14
Physical function test that assesses the number of sit-stand-sit transitions that a participant performs in the span of 30 seconds.
Time frame: End of intervention (14 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity Behavior Intervention | 30-Second Chair-Stand Test W14 | 13 sit-stand-sit transitions |
| Attention Control | 30-Second Chair-Stand Test W14 | 12 sit-stand-sit transitions |
p-value: 0.58495% CI: [-0.67, 2.07]Mixed Models Analysis
Secondary
30-Second Chair-Stand Test W38
Physical function test that assesses the number of sit-stand-sit transitions that a participant performs in the span of 30 seconds.
Time frame: 24 weeks after intervention (week 38 of study)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity Behavior Intervention | 30-Second Chair-Stand Test W38 | 14 sit-stand-sit transitions |
| Attention Control | 30-Second Chair-Stand Test W38 | 14 sit-stand-sit transitions |
p-value: 0.72495% CI: [-1.4, 1.32]Mixed Models Analysis
Secondary
Free-living Daily Step Count W38
Accelerometer-based measurement of free-living daily step count
Time frame: 24 weeks after intervention (week 38 of study)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity Behavior Intervention | Free-living Daily Step Count W38 | 7287 step count |
| Attention Control | Free-living Daily Step Count W38 | 6855 step count |
p-value: 0.10195% CI: [-405.01, 1524.62]Mixed Models Analysis
Secondary
Six-Minute Walk Test W14
Physical function test measuring the total distance walked in a span of six minutes.
Time frame: End of intervention (14 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity Behavior Intervention | Six-Minute Walk Test W14 | 433 meters |
| Attention Control | Six-Minute Walk Test W14 | 434 meters |
p-value: 0.54795% CI: [-18.9, 33.89]Mixed Models Analysis
Secondary
Six-Minute Walk Test W38
Physical function test measuring the total distance walked in a span of six minutes.
Time frame: 24 weeks after intervention (week 38 of study)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity Behavior Intervention | Six-Minute Walk Test W38 | 452 meters |
| Attention Control | Six-Minute Walk Test W38 | 451 meters |
p-value: 0.71695% CI: [-21.67, 31.54]Mixed Models Analysis
Secondary
Timed Up-and-Go Test W14
A physical performance measure that includes rising from a chair, walking 3 meters, turning 180 degrees, returning to chair, and sitting.
Time frame: End of intervention (14 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity Behavior Intervention | Timed Up-and-Go Test W14 | 9.8 seconds |
| Attention Control | Timed Up-and-Go Test W14 | 9.4 seconds |
p-value: 0.94695% CI: [-0.88, 0.82]Mixed Models Analysis
Secondary
Timed Up-and-Go Test W38
A physical performance measure that includes rising from a chair, walking 3 meters, turning 180 degrees, returning to chair, and sitting.
Time frame: 24 weeks after intervention (week 38 of study)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity Behavior Intervention | Timed Up-and-Go Test W38 | 9.1 seconds |
| Attention Control | Timed Up-and-Go Test W38 | 9.0 seconds |
p-value: 0.90695% CI: [-1.08, 0.52]Mixed Models Analysis
Secondary
Veterans RAND 12-Item Health Survey Mental Component W14
A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
Time frame: End of intervention (14 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity Behavior Intervention | Veterans RAND 12-Item Health Survey Mental Component W14 | 54 Percentage of total |
| Attention Control | Veterans RAND 12-Item Health Survey Mental Component W14 | 52 Percentage of total |
p-value: 0.8895% CI: [-4.08, 2.68]Mixed Models Analysis
Secondary
Veterans RAND 12-Item Health Survey Mental Component W38
A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
Time frame: 24 weeks after intervention (week 38 of study)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity Behavior Intervention | Veterans RAND 12-Item Health Survey Mental Component W38 | 55 Percentage of total |
| Attention Control | Veterans RAND 12-Item Health Survey Mental Component W38 | 51 Percentage of total |
p-value: 0.8595% CI: [-2.63, 4.17]Mixed Models Analysis
Secondary
Veterans RAND 12-Item Health Survey Physical Component W14
A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
Time frame: End of intervention (14 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity Behavior Intervention | Veterans RAND 12-Item Health Survey Physical Component W14 | 43 Percentage of total |
| Attention Control | Veterans RAND 12-Item Health Survey Physical Component W14 | 39 Percentage of total |
p-value: 0.22395% CI: [-0.39, 6.12]Mixed Models Analysis
Secondary
Veterans RAND 12-Item Health Survey Physical Component W38
A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
Time frame: 24 weeks after intervention (week 38 of study)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity Behavior Intervention | Veterans RAND 12-Item Health Survey Physical Component W38 | 43 Percentage of total |
| Attention Control | Veterans RAND 12-Item Health Survey Physical Component W38 | 41 Percentage of total |
p-value: 0.38895% CI: [-2.19, 4.53]Mixed Models Analysis
Secondary
Western Ontario and McMaster Universities Osteoarthritis Index W14
Self-report health status measure of pain, stiffness, and function for people with osteoarthritis of the hip or knee. A higher score indicates worse outcome with the Total Score range from 0-96. A positive change indicates worse outcome and a negative change indicates a better outcome across time points.
Time frame: End of intervention (14 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity Behavior Intervention | Western Ontario and McMaster Universities Osteoarthritis Index W14 | 18 score on a scale |
| Attention Control | Western Ontario and McMaster Universities Osteoarthritis Index W14 | 21 score on a scale |
p-value: 0.87395% CI: [-7.59, 4.49]Mixed Models Analysis
Secondary
Western Ontario and McMaster Universities Osteoarthritis Index W38
Self-report health status measure of pain, stiffness, and function for people with osteoarthritis of the hip or knee. A higher score indicates worse outcome with the Total Score range from 0-96. A positive change indicates worse outcome and a negative change indicates a better outcome across time points.
Time frame: 24 weeks after intervention (week 38 of the study)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity Behavior Intervention | Western Ontario and McMaster Universities Osteoarthritis Index W38 | 13 score on a scale |
| Attention Control | Western Ontario and McMaster Universities Osteoarthritis Index W38 | 22 score on a scale |
p-value: 0.24195% CI: [-12.48, -0.04]Mixed Models Analysis