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

University of South Carolina1 个研究点分布在 1 个国家目标入组 181 人2022年1月4日

适应症Arthroplasty Overweight and Obesity

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Arthroplasty
发起方: University of South Carolina
入组人数: 181
试验地点: 1
主要终点: Change in body weight at 6 months
状态: 进行中（未招募）
最后更新: 3个月前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

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.

详细描述

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.

注册库

clinicaltrials.gov

开始日期

2022年1月4日

结束日期

2027年7月30日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

University of South Carolina

责任方

Principal Investigator

主要研究者

Christine A Pellegrini, PhD

Assistant Professor

University of South Carolina

入排标准

入选标准

•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.

排除标准

•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.

结局指标

主要结局

Change in body weight at 6 months

时间窗: 6 months

次要结局

Change in Timed Up & Go at 18 months(18 months)
Change in WOMAC pain subscale at 18 months(18 months)
Change in Chair Stands at 12 months(12 months)
Change in Six Minute Walk Duration at 6 months(6 months)
Change in WOMAC pain subscale at 6 months(6 months)
Change in Chair Stands at 18 months(18 months)
Change in body weight at 12 months(12 months)
Change in Six Minute Walk Duration at 18 months(18 months)
Change in Timed Up & Go at 6 months(6 months)
Change in Chair Stands at 6 months(6 months)
Change in body weight at 18 months(18 months)
Change in WOMAC pain subscale at 12 months(12 months)
Change in Six Minute Walk Duration at 12 months(12 months)
Change in Timed Up & Go at 12 months(12 months)
Change in Moderate to vigorous intensity physical activity at 6 months(6 months)
Change in Moderate to vigorous intensity physical activity at 12 months(12 months)
Change in Moderate to vigorous intensity physical activity at 18 months(18 months)