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OpenTrials
Active, Not Recruiting

NCT Number: NCT05190666

Healthy Living After Knee Replacement

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Arthroplasty Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PACE Weight Loss program

Behavioral

12 month phone-based behavioral weight loss program

Chronic Disease Self-Management

Behavioral

12 month phone-based chronic disease self-management program

Primary outcomes

  1. Change in body weight at 6 months

    Time frame: 6 months

    kg

Secondary outcomes

  1. Change in WOMAC pain subscale at 6 months

    Time frame: 6 months

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

  2. Change in WOMAC pain subscale at 12 months

    Time frame: 12 months

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

  3. Change in WOMAC pain subscale at 18 months

    Time frame: 18 months

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

  4. Change in Six Minute Walk Duration at 6 months

    Time frame: 6 months

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

  5. Change in Six Minute Walk Duration at 12 months

    Time frame: 12 months

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

  6. Change in Six Minute Walk Duration at 18 months

    Time frame: 18 months

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

  7. Change in Timed Up & Go at 6 months

    Time frame: 6 months

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

  8. Change in Timed Up & Go at 12 months

    Time frame: 12 months

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

  9. Change in Timed Up & Go at 18 months

    Time frame: 18 months

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

  10. Change in Chair Stands at 6 months

    Time frame: 6 months

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

  11. Change in Chair Stands at 12 months

    Time frame: 12 months

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

  12. Change in Chair Stands at 18 months

    Time frame: 18 months

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

  13. Change in Moderate to vigorous intensity physical activity at 6 months

    Time frame: 6 months

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

  14. Change in Moderate to vigorous intensity physical activity at 12 months

    Time frame: 12 months

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

  15. Change in Moderate to vigorous intensity physical activity at 18 months

    Time frame: 18 months

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

  16. Change in body weight at 12 months

    Time frame: 12 months

    kg

  17. Change in body weight at 18 months

    Time frame: 18 months

    kg

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jan 13, 2022
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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