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临床试验/NCT04490395
NCT04490395已完成不适用

Increasing Physical Resilience in Older Adults With Osteoarthritis Pain: Feasibility and Acceptability of a Brief Behavioral Physical Activity Intervention

Duke University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年1月5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
40
试验地点
2
主要终点
Number of Participants Enrolled in the Study

研究概览

简要总结

The purpose of this study is to evaluate how older adults might benefit from sessions that teach behavioral coping skills for increasing physical activity and reducing interference from arthritis pain. This study will randomize individuals to receive Engage-PA, or continue to receive treatment as usual. Engage-PA involves two sessions (about 45 minutes each) with a study therapist that teaches individuals behavioral skills for increasing daily steps. These behavioral skills include identifying their personal values and instructions on how to pace their daily physical activity to avoid creating severe pain when walking. All participants in the study will wear small devices that track physical activity such as daily steps throughout the study, which also allow participants to see their daily step counts and overall level of activity. All participants will answer a set of questions about how much arthritis gets the way of many important life activities, their success at living in line with their personal values, and how much thoughts, feelings and body sensations get in the way of living a satisfying life. These questions will be asked at the beginning of the study and 6 weeks into the study.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 65 or older
  • English speaking
  • Diagnosis of osteoarthritis in knee or hip
  • Able to ambulate even if assisted with ambulatory device such as walker or cane
  • Endorse worst pain and pain interference as ≥ 3 out of 10 within the last week

排除标准

  • Planned surgery during study duration that would limit mobility (e.g., due to recommended rehabilitation or recovery period) for more than 3 weeks
  • Current enrollment in cardiac rehabilitation
  • Myocardial infarction in the past 3 months
  • Major surgery requiring limited movement or mobility for recovery within the past 3 months
  • Presence of a serious psychiatric condition (e.g., schizophrenia, suicidal intent) indicated by medical chart, treating medical provider or other staff, or study staff interactions that would contraindicate safe study participation
  • Medical provider indicating that exercise (even walking) should only be medically supervised; as determined by medical record review or patient reported
  • Fall or falls within the last 3 months that led to immediate medical treatment/hospitalization
  • Reported or suspected moderate or severe cognitive impairment subsequently informed by a Folstein Mini-Mental Status Examination of <19

结局指标

主要结局

Number of Participants Enrolled in the Study

时间窗: 9 months

How many participants, up to the expected 40 participants, enroll in the study within the study period

Number of Participants Who Completed the Entire Program

时间窗: 6 weeks

Participants who complete all assessments and required study sessions

Percentage of Participants Who Were Mostly or Very Satisfied With the Intervention

时间窗: Post treatment (6 weeks)

Client Satisfaction Questionnaire asks 12 questions related to patient satisfaction on a Likert scale of 1 = very satisfied to 7 = very dissatisfied. There is one item assessing overall satisfaction with the intervention, and the percentage of participants responding to this item with "mostly" or "very" satisfied is reported below.

次要结局

  • Arthritis-related Physical Functioning (AIMS 2 Physical Functioning Subscale)(Baseline, post-treatment (6 weeks))
  • Daily Step Count in 7 Day Period(Baseline, post-treatment (6 weeks))
  • Rapid Assessment of Physical Activity(Baseline, post-treatment (6 weeks))
  • Valued Living - Health Domain(Baseline, post-treatment (6 weeks))
  • Valued Living - Leisure Domain(Baseline, post-treatment (6 weeks))
  • Arthritis Pain (AIMS 2 Symptom Subscale)(Baseline, post-treatment (6 weeks))
  • Psychological Distress (AIMS 2 Affect Subscale)(Baseline, post-treatment (6 weeks))
  • Psychological Flexibility(Baseline, post-treatment (6 weeks))
  • Valued Living - Relationship Domain(Baseline, post-treatment (6 weeks))
  • Valued-Living - Work/Community Domain(Baseline, post-treatment (6 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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