跳至主要内容
临床试验/NCT04099394
NCT04099394进行中(未招募)不适用

Randomized Controlled Trial of Group-Based Exercise and Behavioral Health Skills Training for Older Adults with Painful Knee Osteoarthritis

University of Washington2 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2019年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
280
试验地点
2
主要终点
Average Number of Steps per day

研究概览

简要总结

This clinical trial will determine the added benefit of combining exercise and behavioral health education (versus exercise and aging and health education) to improve physical activity in community-dwelling older adults who have painful knee osteoarthritis (OA).

详细描述

Knee osteoarthritis (OA) is a highly prevalent, leading cause of pain that limits physical functioning in older adults. Although clinical practice guidelines recommend physical exercise for managing symptoms of knee OA, several systematic reviews indicate that exercise intervention studies provide only short-term benefits (lasting 6 months) for knee OA. Many older adults with painful knee OA return to sedentary lifestyles when structured exercise programs end6. Efforts to increase and sustain physical activity in this population will require promoting self-regulatory skills to develop confidence to maintain an active lifestyle and manage symptoms that often limit activity. Therefore, we developed a group-based behavioral health (BH) program for older adults with painful knee OA that complements Enhance Fitness (EF) - a multicomponent, community-based exercise program for older adults, involving balance, strength, and endurance training. The Behavioral Health (BH) program will have 10, 1-hour weekly classes spread over 4 months, while the Health Education (HE) program will be equally matched for attention with classes on aging and health. In parallel with BH/HE programs, all study subjects will participate in Enhance Fitness (EF) exercise classes that will be held for 1-hour, 3 times a week for 4 months. EF+BH intervention (versus EF+HE) improves physical activity, pain, physical function, and other outcomes in older adults with knee OA. Due to the COVID-19 pandemic, all interventions transitioned to remote delivery in 2020.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Average Number of Steps per day

时间窗: 4 months,10 months

Participant's average number of steps per day will be measured by a thigh mounted accelerometer (acitvPAL) worn for 1 week.

次要结局

  • Fatigue(4 months, 10 months)
  • Study Specific Treatment Satisfaction Questionnaire(4 months, 10 months)
  • Patient Global Impression of Change(4 months, 10 months)
  • Knee Pain and Function(4 months, 10 months)
  • Timed Up and Go Test(4 months, 10 months)
  • 6 Minute Walk Test(4 months, 10 months)
  • Short Physical Performance Battery(4 months, 10 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kushang Patel

Research Associate Professor: School of Medicine: Anesthesiology and Pain Medicine

University of Washington

研究点 (2)

Loading locations...

相似试验