The PATH Study to Promote Physical Activity After Knee Replacement

Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03768206
• Other study ID #: Pro00081254
• Status: Completed
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: June 15, 2020

Study information

• Verified date: July 2021
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 15, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthroplasty

Intervention

Behavioral:
• 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.
• Physical activity session
Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement.

Locations

Country	Name	City	State
United States	Palmetto Health- USC Orthopedic Center	Columbia	South Carolina
United States	University of South Carolina	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of South Carolina	Prisma Health-Midlands

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Enrolled	Feasibility will be determined based on the number of participants enrolled vs. the number approached	Baseline
Primary	Percentage of Participants Who Complete the 12 Week Assessment	Acceptability will be determined by the percentage of participants completing the 12 week assessment.	12 weeks
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.	12 weeks