Physical Activity
Conditions
Keywords
Total Knee Replacement, Physical Therapy
Brief summary
Background: The definitive treatment for knee osteoarthritis is Total Knee Replacement (TKR), which results in clinically meaningful improvements in pain and physical function. However, evidence suggests that physical activity remains unchanged after TKR. This randomized clinical trial is investigating the efficacy, fidelity, and safety of a physical therapist administered physical activity intervention for people after TKR. Methods/Design: One hundred and twenty individuals, over the age of 45, who seek outpatient Physical Therapy (PT) following a unilateral TKR will be randomized into a control and intervention group. The intervention group will receive a weekly physical activity intervention during PT, which includes a FitbitTM monitor, individualized step goals, and face-to-face feedback provided by the physical therapist. Efficacy of the intervention will be measured by minutes/week spent in Moderate-to-Vigorous Physical Activity (MPVA) using an Actigraph GT3X monitor from enrollment to discharge, 6 months and 12 months from discharge from PT. The association of self-efficacy for exercise and kinesiophobia with physical activity will also be measured at the same time points. Fidelity and safety of the intervention will be assessed during outpatient PT. Discussion: This study is designed to fill a critical clinical need to increase physical activity after TKR. The primary objective of the study is to evaluate the efficacy of a physical therapist administered physical activity intervention for people after TKR. The secondary objectives are to evaluate the fidelity and safety of a physical therapist administered physical activity intervention for people after TKR and to investigate changes in self-reported and performance-based physical function after a physical therapist administered physical activity intervention for people after TKR. The tertiary objective is to explore the association of psychosocial factors with physical activity 6 and 12 months after discharge from a physical therapist administered physical activity intervention for people after TKR. The findings will be used to support a large multi-site clinical trial to test the effectiveness, implementation, and cost of this intervention.
Interventions
BEHAVIORALStandardize PT after TKR with a Physical Activity Intervention
Standardized PT and a physical activity intervention. Participants will be provided a FitbitTM Zip within one week after enrolling in the study. Participants will self-track their steps/day using their FitbitTM Zip. Participants ≤ 3 weeks' post-operative TKR are expected to maintain and not increase steps/day. Beyond 3 weeks after surgery, step goals will be initiated and evaluated on a weekly basis. Progression of weekly steps/day goal will be a joint decision between the participant and physical therapist. As a guide, a 10-20% increase in steps/day until at least 6,000 steps/day is achieved. Each week the physical therapist will review the participant's steps/day goal and if at least 4 of the 7 previous days per week were at or above the prior week's steps/day goal, then next week's steps/day goal will increase. The physical therapist will discuss current steps/day with the participant using the Fitbit TM Zip and set a personalized steps/day goal each week during PT.
OTHERStandardized PT after TKR
Participants in the control group will receive standardized PT provided by a licensed physical therapist at UDPT using the University of Delaware's Rehabilitation Guidelines for Unilateral Total Knee Replacement. Standardized PT also includes a printed home exercise program with an exercise log that is updated weekly by a physical therapist. PT appointment times range from 45-60 minutes with appointment occurring 1-3 times a week for 6-8 weeks.
Sponsors
University of Delaware
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Over the age of 45 2. Seeking outpatient physical therapy for a unilateral TKR
Exclusion criteria
1. Not interested in increasing physical activity 2. Any other medical conditions that limit your physical activity 3. Have had or are planning on having another leg surgery within 6 months that is unrelated to your TKR surgery 4. Previously enrolled in a physical activity intervention study at this clinic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity Measured by an Actigraph GT3X Monitor | Baseline, discharge from PT, and 6 months after PT discharge | Time spent in Moderate to Vigorous Physical Activity (MVPA) average minutes/week |
Countries
United States
Participant flow
Pre-assignment details
The study protocol enrolled n=125 study participants, however prior to randomization n=5 subjects dropped out of the study. Hence, n=120 study participants were randomized, which is the number stated in the participant flow module.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group received Outpatient Physical Therapy Plus a Physical Activity Intervention | 55 |
| Control Group received Outpatient Physical Therapy only | 55 |
| Total | 110 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 67.80 years STANDARD_DEVIATION 8.65 | 64.70 years STANDARD_DEVIATION 6.57 | 66.30 years STANDARD_DEVIATION 7.81 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 55 Participants | 109 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Moderate to Vigorous Intensity Physical Activity | 3.94 Minutes/day STANDARD_DEVIATION 9.12 | 6.70 Minutes/day STANDARD_DEVIATION 9.04 | 5.32 Minutes/day STANDARD_DEVIATION 9.15 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 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 | 54 Participants | 52 Participants | 106 Participants |
| Region of Enrollment United States | 55 participants | 55 participants | 110 participants |
| Sex: Female, Male Female | 32 Participants | 27 Participants | 59 Participants |
| Sex: Female, Male Male | 23 Participants | 28 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 62 |
| other Total, other adverse events | 29 / 58 | 39 / 62 |
| serious Total, serious adverse events | 9 / 58 | 5 / 62 |
Outcome results
Primary
Physical Activity Measured by an Actigraph GT3X Monitor
Time spent in Moderate to Vigorous Physical Activity (MVPA) average minutes/week
Time frame: Baseline, discharge from PT, and 6 months after PT discharge
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | Physical Activity Measured by an Actigraph GT3X Monitor | Baseline MVPA | 9.8 Minutes/Week |
| Intervention | Physical Activity Measured by an Actigraph GT3X Monitor | Discharge MVPA | 63 Minutes/Week |
| Intervention | Physical Activity Measured by an Actigraph GT3X Monitor | 6 Months MVPA | 55.3 Minutes/Week |
| Control | Physical Activity Measured by an Actigraph GT3X Monitor | Baseline MVPA | 23.8 Minutes/Week |
| Control | Physical Activity Measured by an Actigraph GT3X Monitor | Discharge MVPA | 86.8 Minutes/Week |
| Control | Physical Activity Measured by an Actigraph GT3X Monitor | 6 Months MVPA | 89.6 Minutes/Week |