跳至主要内容
临床试验/NCT02912221
NCT02912221已完成不适用

Influence of Increased Physical Activity on Patient Reported Measures of Disease Activity in Inflammatory Arthritis

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2017年4月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
71
试验地点
2
主要终点
Percentage of Days Goal Met

研究概览

简要总结

This study will examine the benefits of a monitored physical activity program for participants with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) using a wearable activity device (e.g.fitbit). The goals of this pilot study are to examine 1) whether an incentive is better than no incentive in maintaining an increased level of physical activity and 2) the benefits of physical activity on patient reported disease activity in inflammatory arthritis.

详细描述

Rheumatoid arthritis (RA) and psoriatic arthritis (PsA) are chronic, systemic inflammatory disorders affecting 1-2% of the US population. Ongoing chronic inflammation and lack of exercise due to arthritis are each associated with pain, fatigue, depression, muscle loss, obesity, and development of chronic diseases such as cardiovascular disease and diabetes, all of which impact physical functioning and quality of life. Increases in physical activity can significantly impact each one of these outcomes and are likely to positively impact a patients experience of their disease. This study will examine the benefits of a monitored physical activity program. This study will use a wearable activity device (e.g. fitbit) to monitor step counts and will incentivize one group to achieve higher step counts than the control group. The primary goal of this pilot study will be to determine whether one incentive (loss aversion) is better than no incentive in increasing step counts and maintaining an increased level of physical activity.

Additional outcomes of interest are patient reported disease activity (using the RAPID3 patient reported outcome) and physician measured disease activity, quality of life assessments and weight loss.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A diagnosis of RA or PsA by a rheumatologist
  • Followed by a Penn rheumatologist
  • Age 18-80
  • A RAPID3 score of 3
  • An active email account
  • Owns a smart phone and able to download an application
  • Willing to take internet based surveys weekly and allow data from a smart phone application to be uploaded

排除标准

  • Inability to walk or regular use of a wheel chair or assistive device (e.g., walker or cane)
  • Hospitalization within the past 30 days
  • Heart or lung disease that precludes participation in an exercise study

结局指标

主要结局

Percentage of Days Goal Met

时间窗: 12 Weeks

The primary outcome will be percent of days meeting goal during the intervention period

次要结局

  • RAPID3(26 Weeks)
  • Psoriasis(26 Weeks)
  • Patient Feedback(14 Weeks and 26 Weeks)
  • Sleep Disturbance and Fatigue(26 Weeks)
  • Completion of Activities by Study Participants (Feasibility)(26 Weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验