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临床试验/NCT06880653
NCT06880653招募中不适用

Examination of the Dose Response Relationship Between Physical Activity and Arthritis-Attributable Outcomes

University of South Carolina2 个研究点 分布在 1 个国家目标入组 285 人开始时间: 2025年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
285
试验地点
2
主要终点
Physical function (6 Minute Walk Test)

研究概览

简要总结

The purpose of the study is to see examine the effects of 3 different levels of physical activity (45 minutes/week, 90 minutes/week, or 150 minutes/week) on arthritis symptoms.

详细描述

All participants will be randomly assigned a physical activity goal (45 min/week, 90 min/week, or 150 min/week). To help participants achieve goals, they will receive a 6 month program which includes the Arthritis Foundation's Walk With Ease Guidebook, behavioral lessons, a Fitbit, and monthly coaching calls. Participants may also receive additional calls, texts, or emails if they are struggling to meet their physical activity goals.

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 (Outcomes Assessor)

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

  • 18 years or older
  • Have a doctor diagnosed form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia
  • Ability to read and write in English

排除标准

  • Have any contraindications to exercise (besides arthritis)
  • Engage in ≥30 min/week of Actigraph assessed MVPA
  • Are pregnant, breastfeeding, or planning to become pregnant in the next year
  • Are planning to relocate out of the Columbia, SC area in the next 12 months,
  • Do not have a device compatible with Fitbit
  • Have uncontrolled hypertension (e.g., systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg)
  • Plan to have a surgery that affects mobility in the next 12 months
  • Have a serious cognitive impairment.
  • Not willing to be randomized to any of the 3 conditions, do not believe they could adhere to the goals, or do not believe they could achieve the highest dose of activity (150 minutes/week).

结局指标

主要结局

Physical function (6 Minute Walk Test)

时间窗: Baseline to 6 months

Change in distance walked during the 6 minute walk test

次要结局

  • Physical function (6 Minute Walk Test)(Baseline to 12 months)
  • Physical function (chair stands)(Baseline to 12 months)
  • Health Related Quality of Life - Physical(Baseline to 12 months)
  • Health Related Quality of Life - Mental(Baseline to 12 months)
  • Pain intensity(Baseline to 12 months)
  • Depression symptoms(Baseline to 12 months)

研究者

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

Christine A Pellegrini, PhD

Associate Professor

University of South Carolina

研究点 (2)

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