跳至主要内容
临床试验/NCT02075931
NCT02075931已完成不适用

Collaborative-care Intervention to Promote Physical Activity After Total Knee Arthroplasty

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2014年2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
已完成
入组人数
45
试验地点
1
主要终点
Change in Physical activity

研究概览

简要总结

The investigators have learned that knee replacement patients are not more physically active after surgery. This is true even though their pain is less compared to before surgery. This low level of physical activity is not healthy. It can increase the chances of weight gain, which can create other issues. It can also lessen physical function. Some studies have looked at physical activity feedback systems to increase how active people are. Studies have investigated face to face patient group meetings for this,too. These systems and meetings can increase physical activity. The investigators will study the effects of a physical activity monitors with group meetings after knee replacement. The investigators hypothesize that physical activity levels and physical function will increase. The investigators goal is to help knee replacement patients lead healthier lives and maintain or enhance their physical function.

详细描述

More than 650,000 total knee arthroplasties (TKAs) are performed annually to alleviate pain and disability associated with osteoarthritis (OA); a chronic, degenerative condition that compromises the quality of life of 37% of adults over age 60. With the aging of the population, an estimated 3.5 million TKAs will be performed annually by 2030. Despite improvements in pain and self-reported function, physical activity after TKA remains at pre-operative, sedentary levels (<5,000 steps/day). Physical activity in TKA confers powerful protective effects against common post-surgical sequelae including increased weight gain (mean=6.4 kg, 2 years post TKA), decreased functional performance, increased risk/progression of co-morbid conditions (e.g. type 2 diabetes mellitus, cardiovascular disease), and progression of knee and hip osteoarthritis which may necessitate additional joint replacement in the contralateral limb. An intervention aimed at improved self-management of physical activity may aid patients in overcoming habitual lifestyle patterns of low physical activity secondary to knee pain prior to TKA.

Recent investigations on the effects of real-time, user-friendly, electronic physical activity feedback (PAF) systems and face-to-face (FTF) patient group meetings aimed to promote self-management of physical activity suggest that such interventions can successfully increase physical activity. Therefore, the investigators propose a randomized, controlled trial to assess efficacy and feasibility of a physical activity intervention combined with FTF group meetings (PAF+FTF) initiated within one month of patients' discharge from outpatient rehabilitation for TKA compared to a control group receiving standard care (CON). This type of intervention is surprisingly novel to this patient population and is not common practice in rehabilitation following TKA.

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
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •undergone unilateral total knee arthroplasty

排除标准

  • •severe contralateral leg osteoarthritis (>4/10 with stair climbing)
  • •unstable orthopaedic condition that limits function
  • •neurological conditions that affect muscle function
  • •vascular or cardiac conditions that limit function

研究组 & 干预措施

Physical Activity Feedback

Experimental

The physical activity feedback intervention will involve real-time physical activity monitoring using a device to provide activity feedback directly to patients in combination with patient group meetings held monthly during the 12 week intervention for the purposes of mutual support in attaining physical activity goals.

干预措施: Physical activity feedback with group meetings (Other)

Control

Active Comparator

The control represents the current standard of care post total knee arthroplasty.

干预措施: Control (Other)

结局指标

主要结局

Change in Physical activity

时间窗: Change from baseline to immediately post-12 week intervention

Daily step and activity counts

次要结局

  • Change in Self-reported physical function(Change from baseline to immediately post-12 week intervention)
  • Change in Functional performance(Change from baseline to immediately post-12 week intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验