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Clinical Trials/NCT03768206
NCT03768206CompletedNot Applicable

Promoting Physical Activity Via Physical Therapist Following Knee Replacement- The PATH Study

University of South Carolina2 sites in 1 country45 target enrollmentStarted: January 14, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
45
Locations
2
Primary Endpoint
Percentage of Participants Who Complete the 12 Week Assessment

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to 79 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

PATH

Experimental

PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity & assist with goal setting during therapy sessions.

Intervention: Standard Physical Therapy (Behavioral)

PATH

Experimental

PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity & assist with goal setting during therapy sessions.

Intervention: Physical therapist discuss aerobic physical activity (Behavioral)

PATH-12

Active Comparator

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.

Intervention: Standard Physical Therapy (Behavioral)

PATH-12

Active Comparator

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.

Intervention: Physical activity session (Behavioral)

Outcomes

Primary Outcomes

Percentage of Participants Who Complete the 12 Week Assessment

Time Frame: 12 weeks

Acceptability will be determined by the percentage of participants completing the 12 week assessment.

Number of Participants Enrolled

Time Frame: Baseline

Feasibility will be determined based on the number of participants enrolled vs. the number approached

Secondary Outcomes

  • Moderate-Vigorous Intensity Physical Activity(12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christine A Pellegrini, PhD

Assistant Professor

University of South Carolina

Study Sites (2)

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