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NCT03228719 · ClinicalTrials.gov registry record · NA
A Physical Therapist Administered Physical Activity Intervention After Total Knee Replacement
A NA study, sponsored by University of Delaware.
- Completed
- Registry status
- NA
- Development phase
- 125
- Enrollment target
NCT03228719 is a NA study that has completed, run by University of Delaware. The registered enrollment target is 125 participants.
The verdict
NCT03228719, a NA study, has completed, sponsored by University of Delaware.
- COMPLETED
- Registry status
- NA
- Development phase
- 125 participants
- Enrollment target
Study 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 disch
Interventions
- BEHAVIORAL Standardize PT after TKR with a Physical Activity Intervention
- OTHER Standardized PT after TKR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2017-07-24 |
| Est. Completion | 2022-04-21 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03228719
The ClinicalTrials.gov registry entry for NCT03228719 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Delaware, which has 106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standardize PT after TKR with a Physical Activity Intervention is the first listed.
NCT03228719 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03228719 about?
NCT03228719 is a clinical study titled "A Physical Therapist Administered Physical Activity Intervention After Total Knee Replacement". 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 investigat...
What is the current status of trial NCT03228719?
This trial is currently completed. It is a NA study. The enrollment target is 125 participants. The study started on 2017-07-24. Estimated completion is 2022-04-21.
What interventions are being tested in trial NCT03228719?
The interventions under investigation include: Standardize PT after TKR with a Physical Activity Intervention (BEHAVIORAL), Standardized PT after TKR (OTHER).
Who is sponsoring clinical trial NCT03228719?
This trial is sponsored by University of Delaware, which has 106 total clinical trials registered on ClinicalTrials.gov.
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