Knee Arthroplasty
Conditions
Keywords
knee arthroplasty, behavioral intervention, physical activity
Brief summary
The purpose of this study is to examine the feasibility and preliminary efficacy of a physical therapist led physical activity intervention for knee replacement patients within an outpatient physical therapy facility.
Detailed description
Physical activity does not typically increase after knee replacement; thus, the purpose of this study is to examine if physical activity levels will be higher among knee replacement patients who receive a physical therapist led physical activity intervention during standard physical therapy sessions. Physical activity levels will be assessed at the start of outpatient therapy and at 12 weeks after surgery.
Interventions
BEHAVIORALStandard Physical Therapy
Participants will receive standard outpatient physical therapy that is typical following knee replacement
BEHAVIORALPhysical therapist discuss aerobic physical activity
Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement.
BEHAVIORALPhysical activity session
Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement.
Sponsors
Prisma Health-Midlands
University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
* Be 40-79 years of age * Have had a knee replacement in the last 2 months * Be willing to wear and accelerometer for 7 days during assessments * Be English speaking
Exclusion criteria
* Have any contraindications to activity * Have a mobility limiting comorbidity * Have a scheduled surgery within the next 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Enrolled | Baseline | Feasibility will be determined based on the number of participants enrolled vs. the number approached |
| Percentage of Participants Who Complete the 12 Week Assessment | 12 weeks | Acceptability will be determined by the percentage of participants completing the 12 week assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Moderate-Vigorous Intensity Physical Activity | 12 weeks | Total number of minutes of objectively-measured moderate-vigorous intensity (\>2020 counts/min) physical activity/week assessed using Actigraph link activity monitors worn around the waist for 7 days. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PATH PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity & assist with goal setting during therapy sessions.
Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement
Physical therapist discuss aerobic physical activity: Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement. | 24 |
| PATH-12 PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery.
Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement
Physical activity session: Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement. | 21 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | PATH | Total | PATH-12 |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 28 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 17 Participants | 11 Participants |
| Age, Continuous | 67.2 years STANDARD_DEVIATION 5.4 | 65.4 years STANDARD_DEVIATION 7 | 63.3 years STANDARD_DEVIATION 8.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 45 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Moderate-vigorous intensity physical activity | 37.8 minutes/week STANDARD_DEVIATION 56.8 | 31.5 minutes/week STANDARD_DEVIATION 45.2 | 23.5 minutes/week STANDARD_DEVIATION 22.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 13 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 31 Participants | 13 Participants |
| Region of Enrollment United States | 24 participants | 45 participants | 21 participants |
| Sex: Female, Male Female | 16 Participants | 27 Participants | 11 Participants |
| Sex: Female, Male Male | 8 Participants | 18 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 21 |
| other Total, other adverse events | 0 / 24 | 0 / 21 |
| serious Total, serious adverse events | 0 / 24 | 0 / 21 |
Outcome results
Primary
Number of Participants Enrolled
Feasibility will be determined based on the number of participants enrolled vs. the number approached
Time frame: Baseline
Population: The overall number of participants analyzed reflects the total number of participants that were approached and screened for participation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Participants Approached | Number of Participants Enrolled | 45 Participants |
Primary
Percentage of Participants Who Complete the 12 Week Assessment
Acceptability will be determined by the percentage of participants completing the 12 week assessment.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Participants Approached | Percentage of Participants Who Complete the 12 Week Assessment | 22 Participants |
| PATH-12 | Percentage of Participants Who Complete the 12 Week Assessment | 19 Participants |
Secondary
Moderate-Vigorous Intensity Physical Activity
Total number of minutes of objectively-measured moderate-vigorous intensity (\>2020 counts/min) physical activity/week assessed using Actigraph link activity monitors worn around the waist for 7 days.
Time frame: 12 weeks
Population: Only participants with 4 valid days of activity monitor wear (at least 10 hours of wear time) were included in analyses
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Participants Approached | Moderate-Vigorous Intensity Physical Activity | 48.5 minutes/week | Standard Deviation 55.4 |
| PATH-12 | Moderate-Vigorous Intensity Physical Activity | 57.4 minutes/week | Standard Deviation 62.9 |