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临床试验/NCT01874977
NCT01874977已完成不适用

Randomized Controlled Trial of a Physical Activity Intervention for RA Fatigue

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
2
主要终点
PROMIS Fatigue scale

研究概览

简要总结

The major goal of this project is to conduct a randomized, controlled trial of the impact of a practical, low cost physical activity intervention on fatigue among persons with rheumatoid arthritis (RA). Fatigue has been identified as a major concern for individuals with RA, and is considered a core outcome measure for RA. Our recent study of the sources of fatigue identified physical inactivity as a primary predictor of fatigue. Studies have examined the impact of exercise interventions on RA outcomes, but most of these interventions have focused on pain or function as outcomes. The few exercise studies examining fatigue suggest that increasing physical activity reduces fatigue, but the interventions have been resource-intensive, requiring specially trained personnel to administer them, highly structured activities, and/or attendance at classes or a specified facility. Each of these components increases the cost and barriers to implementation of an intervention. Pedometers have been shown to be an effective means of increasing physical activity, and could form the basis of a simple means to increase physical activity.

This project will test the effect of a simple pedometer-based intervention, with two incremental degrees of guidance, on increasing physical activity and decreasing fatigue. Three groups (n=40 in each) will be studied: a control group with an educational pamphlet only, a pedometer-only intervention group, and a pedometer group with step targets. Both intervention groups will keep step-count diaries. Groups will be followed over 20 weeks. We expect that (1) the pedometer-only intervention group will increase activity more than the education group, and the group with step-count targets will demonstrate even greater increases in activity; and (2) greater increases in activity will be associated with greater decreases in fatigue. Secondary outcome measures will include depressive symptoms, self-reported sleep quality, and body composition. Our overall goal is to demonstrate an effective, yet simple and low cost, physical activity intervention to decrease fatigue that could be broadly accessible and have the potential for wide implementation.

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
Single (Participant)

入排标准

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

入选标准

  • Physicians' diagnosis of RA
  • English verbal fluency
  • Residence in the greater San Francisco Bay Area
  • Score ≥20 on 10-item PROMIS fatigue scale, or at least one item rated "often"
  • BMI ≥ 20 kg/m2

排除标准

  • Currently engaging in regular exercise
  • Non-ambulatory or presence of a condition or comorbid disease that would limit the ability to engage in walking (e.g., foot deformities, lower extremity joint surgery upcoming or in past 6 months, myocardial infarction in past 6 months, stroke, congestive heart failure, severe chronic obstructive pulmonary disease).

结局指标

主要结局

PROMIS Fatigue scale

时间窗: change from baseline fatigue score at 20 weeks

次要结局

  • Patient Health Questionnaire-9 (PHQ-9)(change from baseline PHQ-9 score at 20 weeks)
  • Pittsburg Sleep Quality Index (PSQI)(Change from baseline PSQI score at 20 weeks)
  • Change in weight(Change from baseline weight at 20 weeks)

研究者

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

Patti Katz

Professor of Medicine

University of California, San Francisco

研究点 (2)

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