Healthy Living After Knee Replacement

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05190666
• Other study ID #: Pro00109459
• Secondary ID: R01AG070004
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2023
• Source: University of South Carolina
• Contact: Ellen Wingard
• Phone: 803-777-1889
• Email: ewingard[@]mailbox.sc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 30, 2026
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• PACE Weight Loss program
12 month phone-based behavioral weight loss program
• Chronic Disease Self-Management
12 month phone-based chronic disease self-management program

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of South Carolina	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight at 6 months	kg	6 months
Secondary	Change in WOMAC pain subscale at 6 months	WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)	6 months
Secondary	Change in WOMAC pain subscale at 12 months	WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)	12 months
Secondary	Change in WOMAC pain subscale at 18 months	WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)	18 months
Secondary	Change in Six Minute Walk Duration at 6 months	Physical function assessed with the six minute walk test (feet)	6 months
Secondary	Change in Six Minute Walk Duration at 12 months	Physical function assessed with the six minute walk test (feet)	12 months
Secondary	Change in Six Minute Walk Duration at 18 months	Physical function assessed with the six minute walk test (feet)	18 months
Secondary	Change in Timed Up & Go at 6 months	Physical function assessed with the Timed Up & Go Test (seconds)	6 months
Secondary	Change in Timed Up & Go at 12 months	Physical function assessed with the Timed Up & Go Test (seconds)	12 months
Secondary	Change in Timed Up & Go at 18 months	Physical function assessed with the Timed Up & Go Test (seconds)	18 months
Secondary	Change in Chair Stands at 6 months	Physical function assessed with the Chair stand test (# of chair stands)	6 months
Secondary	Change in Chair Stands at 12 months	Physical function assessed with the Chair stand test (# of chair stands)	12 months
Secondary	Change in Chair Stands at 18 months	Physical function assessed with the Chair stand test (# of chair stands)	18 months
Secondary	Change in Moderate to vigorous intensity physical activity at 6 months	Objectively measured by Actigraph accelerometer (>=2020 counts/min)	6 months
Secondary	Change in Moderate to vigorous intensity physical activity at 12 months	Objectively measured by Actigraph accelerometer (>=2020 counts/min)	12 months
Secondary	Change in Moderate to vigorous intensity physical activity at 18 months	Objectively measured by Actigraph accelerometer (>=2020 counts/min)	18 months
Secondary	Change in body weight at 12 months	kg	12 months
Secondary	Change in body weight at 18 months	kg	18 months