The PATH Study to Promote Physical Activity After Knee Replacement

NCT ID: NCT03768206

Last Updated: 2021-07-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-14

Study Completion Date

2020-06-15

Brief Summary

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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

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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.

Conditions

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Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PATH

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

Group Type EXPERIMENTAL

Standard Physical Therapy

Intervention Type BEHAVIORAL

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

Physical therapist discuss aerobic physical activity

Intervention Type BEHAVIORAL

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

PATH-12

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.

Group Type ACTIVE_COMPARATOR

Standard Physical Therapy

Intervention Type BEHAVIORAL

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

Physical activity session

Intervention Type BEHAVIORAL

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

Interventions

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Standard Physical Therapy

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Physical activity session

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Prisma Health-Midlands

OTHER

Sponsor Role collaborator

University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Christine A Pellegrini, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christine Pellegrini, phD

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Locations

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Palmetto Health- USC Orthopedic Center

Columbia, South Carolina, United States

Site Status

University of South Carolina

Columbia, South Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36106651 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Pro00081254

Identifier Type: -

Identifier Source: org_study_id

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