The PATH Study to Promote Physical Activity After Knee Replacement

NCT03768206 | Completed Results

• 1 other identifier: Pro00081254
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Knee Arthroplasty

Keywords

knee arthroplasty; behavioral intervention; physical activity

Outcome Measures

Primary Outcomes (2)

• Number of Participants Enrolled

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

  Baseline

• 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 Outcomes (1)

• Moderate-Vigorous Intensity Physical Activity

  12 weeks

Study Arms (2)

PATH

EXPERIMENTAL

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

Behavioral: Standard Physical Therapy; Behavioral: Physical therapist discuss aerobic physical activity

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.

Behavioral: Standard Physical Therapy; Behavioral: Physical activity session

Interventions

Standard Physical Therapy BEHAVIORAL

Participants will receive standard outpatient physical therapy that is typical following knee replacement

PATH; PATH-12

Physical therapist discuss aerobic physical activity BEHAVIORAL

Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement.

PATH

Physical activity session BEHAVIORAL

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

PATH-12

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have any contraindications to activity
• Have a mobility limiting comorbidity
• Have a scheduled surgery within the next 6 months

Sponsors & Collaborators

• University of South Carolina: lead
• Prisma Health-Midlands: collaborator

Study Sites (2)

Palmetto Health- USC Orthopedic Center

Columbia, South Carolina, 29203, United States

Location

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (1)

• Pellegrini CA, Brown D, DeVivo KE, Lee J, Wilcox S. Promoting physical activity via physical therapist following knee replacement: A pilot randomized controlled trial. PM R. 2023 Aug;15(8):965-975. doi: 10.1002/pmrj.12895. Epub 2022 Dec 15.

  PMID: 36106651 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Christine Pellegrini
• Organization: University of South Carolina

pellegca@mailbox.sc.edu

803-777-0911

Study Officials

• Christine Pellegrini, phD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 7, 2018
• Study Start: January 14, 2019
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: July 21, 2021
• Results First Posted: July 19, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)