A Physical Therapist Administered Physical Activity Intervention After Total Knee Replacement
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 6/29/2018 |
| Start Date: | July 24, 2017 |
| End Date: | March 2021 |
| Contact: | Daniel K White, PT, ScD, MSc |
| Email: | dkw@udel.edu |
| Phone: | 3028317607 |
A Novel Physical Therapy Administered Physical Activity Intervention After TKR: A Randomized Control Trial
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-five 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.
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-five 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.
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
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