Trial Outcomes & Findings for Improving Physical Activity and Gait Symmetry After Total Knee Arthroplasty (NCT NCT04090125)
NCT ID: NCT04090125
Last Updated: 2024-03-05
Results Overview
Minutes of moderate to vigorous intensity PA (MVPA) per week measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Baseline, Month 3
Results posted on
2024-03-05
Participant Flow
Participant milestones
| Measure |
Physical Activity and Symmetry (PAS) Intervention
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
PAS Intervention: The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
|
Attention Control
Participants assigned to the Attention Control (ATT) group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Attention Control: This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
Completed 3-month Follow-up
|
23
|
24
|
|
Overall Study
COMPLETED
|
20
|
24
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Physical Activity and Gait Symmetry After Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Physical Activity and Symmetry (PAS) Intervention
n=30 Participants
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
PAS Intervention: The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
|
Attention Control
n=30 Participants
Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Attention Control: This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
66.1 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
66.2 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3Minutes of moderate to vigorous intensity PA (MVPA) per week measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Outcome measures
| Measure |
Physical Activity and Symmetry (PAS) Intervention
n=23 Participants
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
PAS Intervention: The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
|
Attention Control
n=24 Participants
Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Attention Control: This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
|
|---|---|---|
|
Change From Baseline to Month 3 in Objectively Assessed Physical Activity (Accelerometer)
|
0.59 Minutes per week
Interval 0.12 to 1.07
|
0.36 Minutes per week
Interval -0.12 to 0.84
|
PRIMARY outcome
Timeframe: Baseline, Month 6Minutes of moderate to vigorous intensity PA (MVPA) per week measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Outcome measures
| Measure |
Physical Activity and Symmetry (PAS) Intervention
n=20 Participants
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
PAS Intervention: The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
|
Attention Control
n=24 Participants
Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Attention Control: This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
|
|---|---|---|
|
Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer)
|
0.12 Minutes per week
Interval -0.34 to 0.57
|
0.64 Minutes per week
Interval 0.23 to 1.06
|
PRIMARY outcome
Timeframe: Baseline, Month 3Population: This includes all participants with available insole data at baseline and 6-month follow-up. Some participants did not have usable insole data due to technical issues
Participants will complete a 10 meter walking test while load beneath each foot is recorded using an instrumented insole. Loading symmetry (peak ground reaction force) will be assessed using the limb symmetry index (LSI (\|Surgical/Non-Surgical\|\*100), values lower than 100% indicate less loading of the surgical limb. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Outcome measures
| Measure |
Physical Activity and Symmetry (PAS) Intervention
n=15 Participants
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
PAS Intervention: The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
|
Attention Control
n=19 Participants
Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Attention Control: This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
|
|---|---|---|
|
Change From Baseline to Month 3 in Peak Joint Load Symmetry During Walking
|
0.04 percentage of non-surgical limb force
Interval -0.04 to 0.13
|
-0.02 percentage of non-surgical limb force
Interval -0.09 to 0.06
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: This includes all participants with available insole data at baseline and 6-month follow-up. Some participants did not have usable insole data due to technical issues.
Participants will complete a 10 meter walking test while load beneath each foot is recorded using an instrumented insole. Loading symmetry (peak ground reaction force) will be assessed using the limb symmetry index (LSI (\|Surgical/Non-Surgical\|\*100), values lower than 100% indicate less loading of the surgical limb. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Outcome measures
| Measure |
Physical Activity and Symmetry (PAS) Intervention
n=13 Participants
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
PAS Intervention: The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
|
Attention Control
n=18 Participants
Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Attention Control: This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
|
|---|---|---|
|
Change From Baseline to Month 6 in Peak Joint Load Symmetry During Walking
|
-0.05 percentage of non-surgical limb force
Interval -0.11 to 0.01
|
0.02 percentage of non-surgical limb force
Interval -0.03 to 0.07
|
SECONDARY outcome
Timeframe: Baseline, Month 3Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. This outcome pertains to minutes of physical activity of moderate or greater intensity (metabolic equivalents ≥ 3.0). A square root transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Outcome measures
| Measure |
Physical Activity and Symmetry (PAS) Intervention
n=23 Participants
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
PAS Intervention: The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
|
Attention Control
n=24 Participants
Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Attention Control: This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
|
|---|---|---|
|
Change From Baseline to Month 3 in Self-Reported Physical Activity.
|
3.23 minutes per week
Interval -0.24 to 6.71
|
-0.62 minutes per week
Interval -4.02 to 2.77
|
SECONDARY outcome
Timeframe: Baseline to Month 6Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. This outcome pertains to minutes of physical activity of moderate or greater intensity (metabolic equivalents ≥ 3.0). A square root transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Outcome measures
| Measure |
Physical Activity and Symmetry (PAS) Intervention
n=20 Participants
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
PAS Intervention: The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
|
Attention Control
n=24 Participants
Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Attention Control: This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
|
|---|---|---|
|
Change From Baseline Month 6 in Self-Reported Physical Activity.
|
1.58 Minutes per week
Interval -2.71 to 5.87
|
-0.16 Minutes per week
Interval -4.23 to 3.9
|
SECONDARY outcome
Timeframe: Baseline, Month 3Step counts measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Outcome measures
| Measure |
Physical Activity and Symmetry (PAS) Intervention
n=23 Participants
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
PAS Intervention: The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
|
Attention Control
n=24 Participants
Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Attention Control: This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
|
|---|---|---|
|
Change From Baseline to Month 3 in Steps Per Day
|
0.18 steps per day
Interval 0.04 to 0.32
|
0.33 steps per day
Interval 0.19 to 0.46
|
SECONDARY outcome
Timeframe: Baseline, Month 6Step counts measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Outcome measures
| Measure |
Physical Activity and Symmetry (PAS) Intervention
n=20 Participants
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
PAS Intervention: The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
|
Attention Control
n=24 Participants
Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Attention Control: This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
|
|---|---|---|
|
Change From Baseline to Month 6 in Steps Per Day
|
0.15 steps per day
Interval -0.01 to 0.3
|
0.32 steps per day
Interval 0.18 to 0.46
|
SECONDARY outcome
Timeframe: Baseline, Month 3Minutes of any PA measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Outcome measures
| Measure |
Physical Activity and Symmetry (PAS) Intervention
n=23 Participants
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
PAS Intervention: The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
|
Attention Control
n=24 Participants
Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Attention Control: This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
|
|---|---|---|
|
Change From Baseline to Month 3 in Minutes of Any Physical Activity (PA)
|
0.04 minutes per day
Interval -0.04 to 0.11
|
0.09 minutes per day
Interval 0.02 to 0.17
|
SECONDARY outcome
Timeframe: Baseline, Month 6Minutes of any PA measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Outcome measures
| Measure |
Physical Activity and Symmetry (PAS) Intervention
n=20 Participants
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
PAS Intervention: The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
|
Attention Control
n=24 Participants
Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Attention Control: This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
|
|---|---|---|
|
Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA)
|
0.00 minutes per day
Interval -0.01 to 0.01
|
0.09 minutes per day
Interval 0.0 to 0.18
|
SECONDARY outcome
Timeframe: Baseline, Month 3Minutes of sedentary activity per day, measured via accelerometer
Outcome measures
| Measure |
Physical Activity and Symmetry (PAS) Intervention
n=23 Participants
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
PAS Intervention: The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
|
Attention Control
n=24 Participants
Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Attention Control: This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
|
|---|---|---|
|
Change From Baseline to Month 3 in Sedentary Minutes
|
-5.32 minutes per day
Interval -27.52 to 16.89
|
-26.68 minutes per day
Interval -48.7 to -4.65
|
SECONDARY outcome
Timeframe: Baseline, Month 6Minutes of sedentary activity per day, measured via accelerometer
Outcome measures
| Measure |
Physical Activity and Symmetry (PAS) Intervention
n=23 Participants
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
PAS Intervention: The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
|
Attention Control
n=24 Participants
Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Attention Control: This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
|
|---|---|---|
|
Change From Baseline to Month 6 in Sedentary Minutes
|
-1.37 minutes
Interval -29.66 to 26.92
|
-26.52 minutes
Interval -52.47 to -0.56
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: We had to discontinue administration of balance measures for this study for an extended period of time due to COVID-19, as these tests require the test administrator to be in close proximity to the person being tested. Only 1 person completed all components of this balance test at both baseline and 3-month follow-up.
Berg Balance Scale includes 14 tests of static and dynamic balance. Each item is scored along a 5-point scale, ranging from 0 to 4. Zero indicates the lowest level of function and 4 the highest level of function. The total score ranges from 0 to 56. Lower scores indicate reduced functional mobility.
Outcome measures
| Measure |
Physical Activity and Symmetry (PAS) Intervention
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
PAS Intervention: The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
|
Attention Control
n=1 Participants
Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Attention Control: This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
|
|---|---|---|
|
Change From Baseline to Month 3 in Berg Balance Scale
|
—
|
-4 score on a scale
Interval -4.0 to -4.0
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: We had to discontinue administration of balance measures for this study for an extended period of time due to COVID-19, as these tests require the test administrator to be in close proximity to the person being tested. No participants completed all components of this balance test at both baseline and 6-month follow-up.
Berg Balance Scale includes 14 tests of static and dynamic balance. Each item is scored along a 5-point scale, ranging from 0 to 4. Zero indicates the lowest level of function and 4 the highest level of function. The total score ranges from 0 to 56. Lower scores indicate reduced functional mobility.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 3Population: We had to discontinue administration of balance measures for this study for an extended period of time due to COVID-19, as these tests require the test administrator to be in close proximity to the person being tested. Only 1 person completed all components of this balance test at both baseline and 3-month follow-up.
Brief Balance Evaluation Systems includes 8 tasks across 6 domains. Each item is scored: 0-3 points (0 representing severe impairment and 3 representing no balance impairment), score range is 0-24). Lower scores indicate higher levels of balance impairment.
Outcome measures
| Measure |
Physical Activity and Symmetry (PAS) Intervention
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
PAS Intervention: The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
|
Attention Control
n=1 Participants
Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Attention Control: This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
|
|---|---|---|
|
Change From Baseline to Month 3 in Brief Balance Evaluation Systems Test
|
—
|
1 score on a scale
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: We had to discontinue administration of balance measures for this study for an extended period of time due to COVID-19, as these tests require the test administrator to be in close proximity to the person being tested. No participants completed all components of this balance test at both baseline and 6-month follow-up.
Brief Balance Evaluation Systems includes 8 tasks across 6 domains. Each item is scored: 0-3 points (0 representing severe impairment and 3 representing no balance impairment), score range is 0-24. Lower scores indicate higher levels of balance impairment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Only 1 participant answered enough questions on the Function and Sport and Recreation Subscale to score this subscale, per instrument instructions. This is because in this post-surgical sample many still had activity restrictions and had been instructed to not yet engage in many of the activities on this subscale.
The KOOS is a patient-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. Five KOOS subscale scores were administered: Pain (9 items), Symptoms (7 items), Function in daily living (17 items), Function in Sport and Recreation (5 items), and knee-related Quality of Life (4 items). All items are scored on 5-point Likert scales. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Outcome measures
| Measure |
Physical Activity and Symmetry (PAS) Intervention
n=23 Participants
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
PAS Intervention: The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
|
Attention Control
n=24 Participants
Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Attention Control: This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
|
|---|---|---|
|
Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Pain
|
28.70 score on a scale
Interval 24.24 to 33.16
|
26.19 score on a scale
Interval 21.8 to 30.58
|
|
Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Symptoms
|
23.16 score on a scale
Interval 17.76 to 28.56
|
22.02 score on a scale
Interval 16.72 to 27.32
|
|
Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Quality of Life
|
29.12 score on a scale
Interval 22.08 to 36.16
|
32.66 score on a scale
Interval 25.77 to 39.54
|
|
Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Function in Daily Living
|
20.91 score on a scale
Interval 17.9 to 23.92
|
18.37 score on a scale
Interval 15.41 to 21.33
|
|
Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Function in Sport and Recreation
|
41.7 score on a scale
|
0 score on a scale
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Only 2 participants answered enough questions on the Function and Sport and Recreation Subscale to score this subscale, per instrument instructions. This is because in this post-surgical sample many still had activity restrictions and had been instructed to not yet engage in many of the activities on this subscale. Therefore only four of the subscales were scored and analyzed.
The KOOS is a patient-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. Five KOOS subscale scores were administered: Pain (9 items), Symptoms (7 it4ems) Function in daily living (17 items), Function in Sport and Recreation (5 items), and knee-related Quality of Life (4 items). All items are scored on 5-point Likert scales. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Outcome measures
| Measure |
Physical Activity and Symmetry (PAS) Intervention
n=20 Participants
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
PAS Intervention: The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
|
Attention Control
n=24 Participants
Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Attention Control: This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
|
|---|---|---|
|
Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Pain
|
30.16 score on a scale
Interval 25.43 to 34.89
|
28.72 score on a scale
Interval 24.26 to 33.19
|
|
Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Symptoms
|
29.49 score on a scale
Interval 23.67 to 35.31
|
25.54 score on a scale
Interval 20.04 to 31.04
|
|
Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Quality of life
|
36.47 score on a scale
Interval 28.13 to 44.8
|
34.83 score on a scale
Interval 27.05 to 42.61
|
|
Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Function in daily life
|
22.92 score on a scale
Interval 19.26 to 26.57
|
19.67 score on a scale
Interval 16.29 to 23.04
|
|
Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Function in Sport and Recreation
|
22.9 score on a scale
|
41.7 score on a scale
|
SECONDARY outcome
Timeframe: Baseline, Month 3The Tampa Scale of Kinesiophobia is a 17 item scale for assessing fear of movement. The scale specifically assesses activity avoidance due to pain-related fear of movement. All items are measured on a 4-point scale from "strongly agree" to "strongly disagree." A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement.
Outcome measures
| Measure |
Physical Activity and Symmetry (PAS) Intervention
n=23 Participants
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
PAS Intervention: The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
|
Attention Control
n=24 Participants
Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Attention Control: This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
|
|---|---|---|
|
Change From Baseline to Month 3 in Tampa Scale for Kinesiophobia
|
-4.81 units on a scale
Interval -6.98 to -2.65
|
-2.86 units on a scale
Interval -4.94 to -0.78
|
SECONDARY outcome
Timeframe: Baseline, Month 6The Tampa Scale of Kinesiophobia is a 17 item scale for assessing fear of movement. The scale specifically assesses activity avoidance due to pain-related fear of movement. All items are measured on a 4-point scale from "strongly agree" to "strongly disagree." A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement.
Outcome measures
| Measure |
Physical Activity and Symmetry (PAS) Intervention
n=20 Participants
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
PAS Intervention: The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
|
Attention Control
n=24 Participants
Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Attention Control: This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
|
|---|---|---|
|
Change From Baseline to Month 6 in Tampa Scale for Kinesiophobia
|
-8.31 units on a scale
Interval -10.41 to -6.2
|
-2.86 units on a scale
Interval -4.81 to -0.9
|
Adverse Events
Physical Activity and Symmetry (PAS) Intervention
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Attention Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Physical Activity and Symmetry (PAS) Intervention
n=30 participants at risk
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
PAS Intervention: The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
|
Attention Control
n=30 participants at risk
Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Attention Control: This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Distal radius fracture
|
0.00%
0/30 • Approximately 6 months for each participant (enrollment to completion of 6-month follow-up assessment)
|
3.3%
1/30 • Number of events 1 • Approximately 6 months for each participant (enrollment to completion of 6-month follow-up assessment)
|
|
Cardiac disorders
Heart palpitations
|
3.3%
1/30 • Number of events 1 • Approximately 6 months for each participant (enrollment to completion of 6-month follow-up assessment)
|
0.00%
0/30 • Approximately 6 months for each participant (enrollment to completion of 6-month follow-up assessment)
|
|
Eye disorders
Senile nuclear sclerosis, bilateral
|
3.3%
1/30 • Number of events 1 • Approximately 6 months for each participant (enrollment to completion of 6-month follow-up assessment)
|
0.00%
0/30 • Approximately 6 months for each participant (enrollment to completion of 6-month follow-up assessment)
|
|
Infections and infestations
Cystitis
|
3.3%
1/30 • Number of events 1 • Approximately 6 months for each participant (enrollment to completion of 6-month follow-up assessment)
|
0.00%
0/30 • Approximately 6 months for each participant (enrollment to completion of 6-month follow-up assessment)
|
|
Respiratory, thoracic and mediastinal disorders
Fatigue, shortness of breath
|
3.3%
1/30 • Number of events 1 • Approximately 6 months for each participant (enrollment to completion of 6-month follow-up assessment)
|
0.00%
0/30 • Approximately 6 months for each participant (enrollment to completion of 6-month follow-up assessment)
|
|
Musculoskeletal and connective tissue disorders
Postoperative pain
|
3.3%
1/30 • Number of events 1 • Approximately 6 months for each participant (enrollment to completion of 6-month follow-up assessment)
|
0.00%
0/30 • Approximately 6 months for each participant (enrollment to completion of 6-month follow-up assessment)
|
|
Eye disorders
Cataract surgery
|
3.3%
1/30 • Number of events 1 • Approximately 6 months for each participant (enrollment to completion of 6-month follow-up assessment)
|
0.00%
0/30 • Approximately 6 months for each participant (enrollment to completion of 6-month follow-up assessment)
|
Additional Information
Kelli Allen, PhD
University of North Carolina at Chapel Hill
Phone: 919-966-0558
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place