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Healthy Living After Knee Replacement

Primary Purpose

Arthroplasty, Overweight and Obesity

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PACE Weight Loss program

Chronic Disease Self-Management

About this trial

This is an interventional prevention trial for Arthroplasty

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Participants must:

have a body mass index between 25-45 kg/m2
have had a knee replacement (including primary, staged or independent bilateral, or revision) <6 months prior to baseline assessment
have a computer, tablet, or smartphone with active internet access to self-monitor online and/or have a device or computer compatible with Fitbit
completion of baseline assessment measures (height, weight, function tests, surveys, ≥4 days valid of activity monitoring, and 1 day of dietary recall)
be English-speaking and able to read consent and study materials written in English
be willing to attend 4 in-person assessments.

Exclusion Criteria:

have any contraindications to diet or weight loss
undergo simultaneous bilateral knee replacement or have a scheduled or anticipated knee replacement for the contralateral knee within the next 18 months
have a mobility limiting comorbidity unrelated to knee replacement (e.g. spinal stenosis, fibromyalgia, peripheral vascular disease, stroke)
are taking anti-obesity medications
are enrolled in a formal weight loss program
had or are planning to have bariatric/gastric/lap band surgery
are planning to relocate out of the Columbia or Greenville, SC areas in the next 18 months.

Sites / Locations

University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

PACE Weight Loss Program

Chronic Disease Self-Management Program

Arm Description

Participants randomized to this arm will receive personalized diet, activity, and weight loss goals as well as tools to self-monitor behaviors and weight. To facilitate changes, participants will receive coaching calls weekly during months 1-4, biweekly during months 5-6, and monthly during months 7-12.

Participants randomized to this arm will receive a chronic disease self-management program including a self-management book. Participants will receive regular calls weekly during months 1-4, biweekly during months 5-6, and monthly during months 7-12.

Outcomes

Primary Outcome Measures

Change in body weight at 6 months

Secondary Outcome Measures

Change in WOMAC pain subscale at 6 months

WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)

Change in WOMAC pain subscale at 12 months

WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)

Change in WOMAC pain subscale at 18 months

WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)

Change in Six Minute Walk Duration at 6 months

Physical function assessed with the six minute walk test (feet)

Change in Six Minute Walk Duration at 12 months

Physical function assessed with the six minute walk test (feet)

Change in Six Minute Walk Duration at 18 months

Physical function assessed with the six minute walk test (feet)

Change in Timed Up & Go at 6 months

Physical function assessed with the Timed Up & Go Test (seconds)

Change in Timed Up & Go at 12 months

Physical function assessed with the Timed Up & Go Test (seconds)

Change in Timed Up & Go at 18 months

Physical function assessed with the Timed Up & Go Test (seconds)

Change in Chair Stands at 6 months

Physical function assessed with the Chair stand test (# of chair stands)

Change in Chair Stands at 12 months

Physical function assessed with the Chair stand test (# of chair stands)

Change in Chair Stands at 18 months

Physical function assessed with the Chair stand test (# of chair stands)

Change in Moderate to vigorous intensity physical activity at 6 months

Objectively measured by Actigraph accelerometer (>=2020 counts/min)

Change in Moderate to vigorous intensity physical activity at 12 months

Objectively measured by Actigraph accelerometer (>=2020 counts/min)

Change in Moderate to vigorous intensity physical activity at 18 months

Objectively measured by Actigraph accelerometer (>=2020 counts/min)

Change in body weight at 12 months

Change in body weight at 18 months

Full Information

NCT ID

NCT05190666

First Posted

December 28, 2021

Last Updated

May 11, 2023

Sponsor

University of South Carolina

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT05190666

Brief Title

Healthy Living After Knee Replacement

Official Title

Physical Activity and Weight Loss to Improve Function and Pain After Total Knee Replacement

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 4, 2022 (Actual)

Primary Completion Date

August 30, 2025 (Anticipated)

Study Completion Date

June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of South Carolina

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to examine if a weight loss program designed for adults after knee replacement improves weight loss, physical activity, pain, and function, as well as if the program is cost effective, as compared to a chronic disease self-management program.

Detailed Description

Participants will be randomized to either a weight loss program or chronic disease self-management program. Both programs will be phone-based and include phone calls with a health coach weekly during months 1-4, biweekly during months 5-6, and monthly during months 7-12. Monthly calls with occur between months 13-18. Assessments examining outcomes will be completed at baseline, 6, 12, and 18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthroplasty, Overweight and Obesity

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PACE Weight Loss Program

Arm Type

Experimental

Arm Description

Arm Title

Chronic Disease Self-Management Program

Arm Type

Sham Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

PACE Weight Loss program

Intervention Description

12 month phone-based behavioral weight loss program

Intervention Type

Behavioral

Intervention Name(s)

Chronic Disease Self-Management

Intervention Description

12 month phone-based chronic disease self-management program

Primary Outcome Measure Information:

Title

Change in body weight at 6 months

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Change in WOMAC pain subscale at 6 months

Description

WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)

Time Frame

6 months

Title

Change in WOMAC pain subscale at 12 months

Description

WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)

Time Frame

12 months

Title

Change in WOMAC pain subscale at 18 months

Description

WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)

Time Frame

18 months

Title

Change in Six Minute Walk Duration at 6 months

Description

Physical function assessed with the six minute walk test (feet)

Time Frame

6 months

Title

Change in Six Minute Walk Duration at 12 months

Description

Physical function assessed with the six minute walk test (feet)

Time Frame

12 months

Title

Change in Six Minute Walk Duration at 18 months

Description

Physical function assessed with the six minute walk test (feet)

Time Frame

18 months

Title

Change in Timed Up & Go at 6 months

Description

Physical function assessed with the Timed Up & Go Test (seconds)

Time Frame

6 months

Title

Change in Timed Up & Go at 12 months

Description

Physical function assessed with the Timed Up & Go Test (seconds)

Time Frame

12 months

Title

Change in Timed Up & Go at 18 months

Description

Physical function assessed with the Timed Up & Go Test (seconds)

Time Frame

18 months

Title

Change in Chair Stands at 6 months

Description

Physical function assessed with the Chair stand test (# of chair stands)

Time Frame

6 months

Title

Change in Chair Stands at 12 months

Description

Physical function assessed with the Chair stand test (# of chair stands)

Time Frame

12 months

Title

Change in Chair Stands at 18 months

Description

Physical function assessed with the Chair stand test (# of chair stands)

Time Frame

18 months

Title

Change in Moderate to vigorous intensity physical activity at 6 months

Description

Objectively measured by Actigraph accelerometer (>=2020 counts/min)

Time Frame

6 months

Title

Change in Moderate to vigorous intensity physical activity at 12 months

Description

Objectively measured by Actigraph accelerometer (>=2020 counts/min)

Time Frame

12 months

Title

Change in Moderate to vigorous intensity physical activity at 18 months

Description

Objectively measured by Actigraph accelerometer (>=2020 counts/min)

Time Frame

18 months

Title

Change in body weight at 12 months

Description

Time Frame

12 months

Title

Change in body weight at 18 months

Description

Time Frame

18 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants must: have a body mass index between 25-45 kg/m2 have had a knee replacement (including primary, staged or independent bilateral, or revision) <6 months prior to baseline assessment have a computer, tablet, or smartphone with active internet access to self-monitor online and/or have a device or computer compatible with Fitbit completion of baseline assessment measures (height, weight, function tests, surveys, ≥4 days valid of activity monitoring, and 1 day of dietary recall) be English-speaking and able to read consent and study materials written in English be willing to attend 4 in-person assessments. Exclusion Criteria: have any contraindications to diet or weight loss undergo simultaneous bilateral knee replacement or have a scheduled or anticipated knee replacement for the contralateral knee within the next 18 months have a mobility limiting comorbidity unrelated to knee replacement (e.g. spinal stenosis, fibromyalgia, peripheral vascular disease, stroke) are taking anti-obesity medications are enrolled in a formal weight loss program had or are planning to have bariatric/gastric/lap band surgery are planning to relocate out of the Columbia or Greenville, SC areas in the next 18 months.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ellen Wingard

Phone

803-777-1889

ewingard@mailbox.sc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christine Pellegrini, PhD

Organizational Affiliation

University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of South Carolina

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29208

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christine Pellegrini, PhD.

Phone

803-777-0911

cpellegrini@sc.edu

First Name & Middle Initial & Last Name & Degree

Christine Pellegrini, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

We will also make de-identified study data available 12 months after the primary manuscript is published.

IPD Sharing Time Frame

12 months after primary manuscript is published

IPD Sharing Access Criteria

Open

Learn more about this trial

Healthy Living After Knee Replacement

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