Move and Snooze: Adding Insomnia Treatment to an Exercise Program to Improve Pain Outcomes in Older Adults With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Change in average pain intensity using a 0-10 numerical rating scale between baseline and the 8-week follow-up (post-intervention) period
研究概览
简要总结
This research will compare the effectiveness of a remotely delivered personalized exercise coaching plus an evidence-based sleep improvement intervention to remotely delivered personalized exercise coaching alone for knee osteoarthritis pain.
The study team hypothesize that the combined intervention will result in greater improvements in patient-reported pain intensity, recorded with real-time data capture, than remotely delivered exercise coaching alone.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-reported physician diagnosis of knee osteoarthritis
- •Persistent knee osteoarthritis-related pain of at least moderate intensity (as indicated in the protocol)
- •Indication of persistent symptoms of insomnia, determined by scoring on the Sleep Condition Indicator questionnaire (as indicated in the protocol)
- •If receiving medication for pain or sleep disturbances, having had no change in prescription in the previous three months and be willing to make no other changes to medications for pain or sleep during the active study period.
- •Adequate literacy level to ensure web-based surveys can be completed independently, as assessed using a brief 3-item literacy level screener
排除标准
- •Concurrent diagnosis of a systemic, inflammatory musculoskeletal disorder (e.g., rheumatoid arthritis)
- •Active malignancy
- •Neurological conditions (e.g., movement disorders)
- •Any medical condition which would make graded increase of physical activity unsuitable (determined by a positive answer to the question: "Has a doctor or healthcare professional advised you to avoid physical activity for any reason?").
- •Unable to understand English sufficiently to take part in the intervention.
- •Unable to provide electronic informed consent.
- •Evidence of significant cognitive impairment (i.e., ≥2 errors on a 6-item cognitive screener).
- •Presence of severe psychiatric disorder.
- •Currently participating in an interventional trial or a pain or sleep management program or having done so in the past six months.
- •Visual or hearing impairment that would prevent use of the intervention.
- •Serious physical health concerns necessitating surgery or with a prognosis <6 months
- •Irregular sleep-wake schedule, e.g., shift work.
- •Self-report of diagnosis of a specific sleep disorder other than insomnia that is not currently adequately treated, e.g., sleep apnea or narcolepsy.
- •Currently meeting or exceeding physical activity guidance from the U.S. Department of Health and Human Services (noted in protocol)
研究组 & 干预措施
Move and Snooze program
This includes the personalized exercise program plus Cognitive Behavioral Therapy for Insomnia (CBT-I).
干预措施: Personalized exercise coaching (Behavioral)
Move and Snooze program
This includes the personalized exercise program plus Cognitive Behavioral Therapy for Insomnia (CBT-I).
干预措施: Cognitive behavioral therapy for Insomnia (Behavioral)
Personalized exercise program
干预措施: Personalized exercise coaching (Behavioral)
结局指标
主要结局
Change in average pain intensity using a 0-10 numerical rating scale between baseline and the 8-week follow-up (post-intervention) period
时间窗: Baseline, 8-week follow-up (post-intervention)
This is a one question numerical rating scale in which participants select from 0 (no pain) -10 (worst pain imaginable) numerical rating scale 4 times a day over 7 days during each assessment period (baseline and 8-week follow-up). These four within-day ratings collected over seven days will be averaged for each participant to provide a single pain intensity rating for each assessment period.
次要结局
- Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a questionnaire between baseline and 8-week follow-up (post-intervention)(Baseline, 8-week (post-intervention))
- Change in the PROMIS Pain Interference 8a questionnaire between baseline and 8-week follow-up (post-intervention)(Baseline, 8-week (post-intervention))
- Change in the PROMIS Physical Function questionnaire between baseline and 8-week follow-up (post-intervention)(Baseline, 8-week (post-intervention))
- Change in the Quality of Life subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS) between baseline and 8-week follow-up (post-intervention)(Baseline, 8-week (post-intervention))
- Patient Global Impression of Change at 8-week follow-up (post-intervention)(8-week (post-intervention))
研究者
Daniel Whibley
Assistant Professor of Physical Medicine and Rehabilitation
University of Michigan