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临床试验/NCT03711773
NCT03711773招募中不适用

Outcomes of Low-Impact Group Exercise Program for People With Ankle, Knee, and/or Hip Pain

University of Missouri-Columbia1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2018年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
1
主要终点
VAS Pain scores

研究概览

简要总结

The primary objective of this study is to study how low-impact group exercise classes affect pain scores in patients with knee, hip, and ankle pain when paired with concurrent standard of care dietitian and behavioral health consults.

详细描述

Osteoarthritis is estimated to affect at least 10% of men and 13% of women over 60 years old in the United States. It's estimated roughly 1 million total joint replacements are being performed each year. Studies have suggested that for patients with knee pain that have high BMIs, low strength, and/or have not participated in conservative measures, a low-impact exercise plan when paired with diet counseling and behavioral health classes can improve patient reported outcomes scores in both pain and function. This study seeks to build upon this research and will provide low-impact exercise plans that will be paired with standard of care dietician and behavioral health interventions in order to offer patients a full-scope approach to battling osteoarthritis pain, especially for those with high BMIs, low strength, and/or for patients that have not attempted conservative therapy in the past. We will include patients with knee, hip, and ankle pain.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •18 and over
  • •Ability to attend classes 3x weekly for 6 months with at least a 66% attendance rate
  • •Ability to concurrently attend standard of care dietitian and behavioral health classes for 6 months
  • •Joint pain (knee, ankle, hip)

排除标准

  • •Prisoners

研究组 & 干预措施

Group Physical Therapy Class

Experimental

Group Physical Therapy Classes. Three times weekly, these subjects will have one hour group physical therapy sessions with either a physical therapist, physical therapy assistant, or personal trainer. These sessions will be aimed to improve strength and function in a low-impact setting designed specifically for those with joint pain.

干预措施: Group Physical Therapy Classes (Other)

结局指标

主要结局

VAS Pain scores

时间窗: 6 Months

Subjects will receive VAS pain surveys each group therapy class. These VAS pain scores (visual analog survey) are taken rated between 0, which is no pain, and 10, which is the most pain.

次要结局

  • BMI(6 Months)

研究者

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

James Cook

Professor, Orthopedic Surgery

University of Missouri-Columbia

研究点 (1)

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