COMPARATIVE EFFECTIVENESS OF EXERCISE, COGNITIVE BEHAVIOURAL THERAPY, AND THEIR COMBINATION FOR PEOPLE WITH CHRONIC MUSCULOSKELETAL PAIN AND POOR SLEEP: SLEEPFIT TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 384
- 试验地点
- 4
- 主要终点
- Average Pain severity
研究概览
简要总结
This study aims to find out which lifestyle approach works best for people with chronic musculoskeletal pain (such as low back pain or hip/knee osteoarthritis) who also have poor sleep. Participants will be randomly assigned to one of three 12-month home-based programs: exercise, cognitive behavioral therapy for insomnia (CBT-I), or a combination of both. Each program includes up to 10 online sessions with a physiotherapist and guidance on managing pain, sleep, and physical activity. We will measure changes in pain, sleep quality, and overall health using questionnaires, wearable devices, sensory tests, and blood samples. The goal is to improve understanding of non-medication treatments for pain and sleep problems.
详细描述
Chronic musculoskeletal pain, such as low back pain and osteoarthritis of the hip or knee, is common and often associated with poor sleep, reduced function, and lower quality of life. Lifestyle factors like exercise and sleep management can influence pain and well-being, but it is unclear which approach works best for people with both chronic pain and sleep problems.
This randomized controlled trial will compare the effectiveness of three 12-month home-based lifestyle interventions:
Exercise program Cognitive Behavioral Therapy for Insomnia (CBT-I) Combination of exercise and CBT-I
Participants will be adults with chronic low back pain and/or hip or knee osteoarthritis lasting at least 6 months, who also report poor sleep. Eligible participants will be randomly assigned to one of the three groups. All groups will receive up to 10 online consultations with a physiotherapist over 9 months, plus tailored guidance on pain, sleep, and physical activity.
Assessments will occur at baseline, 2 months, 6 months, and 12 months, and will include:
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 (Investigator)
盲法说明
Biostatistician
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be included if they have persistent LBP defined as i) age ≥18 years; ii) sought or seriously considered care from a primary care clinician or specialist for their LBP within the past 6 weeks; iii) have at least moderate LBP-related interference with normal work or daily activity (including both work outside the home and housework), as assessed by item 8 of the 36-item Short Form Health Survey OR hip or knee OA defined by the National Institute for Health and Care Excellence as: i) age ≥45 years; ii) activity-related hip or knee joint pain; and iii) no morning hip or knee stiffness, or morning stiffness ≤30 minutes)
- •An average pain of ≥4 on an 11-point numerical rating scale (NRS); 0 equals no pain, 10 equals worst pain possible over the last week
- •≥11 on the Insomnia Severity Index
- •Access to a computer/laptop/tablet with internet availability for videoconferencing consultations
- •Willing and able to participate in video consultations
- •Verification that participants recruited in the US are beneficiaries of the Military Health System.
排除标准
- •Self-report engagement in >120 minute per week of at least moderate intensity physical activity within the past 6 months
- •Current or previous engagement in CBT-I in the past 6 months
- •Cognitive impairment (based on ≥7 on the Short Orientation Memory Concentration Test
- •Received an injection of any substance into the study pain site in the previous 3 months
- •Waiting or planning to receive an injection in the study pain site in the next 12 months
- •Had within the past 12 months, or waiting or planning surgery in the next 12 months
- •Neurological or systemic conditions that may affect physical function (e.g. Parkinson's, Active cancers, multiple sclerosis, rheumatoid arthritis, ankylosing spondylitis)
- •Failing the American College of Sports Medicine pre-participation Health Screening Questionnaire without medical clearance to participate
- •Unable to give informed consent and/or participate in the intervention and assessment procedures.
- •Unable to speak or read English.
研究组 & 干预措施
Aerobic physical activity
干预措施: Aerobic physical activity (Behavioral)
CBT-I
Cognitive behaviour therapy for insomnia
干预措施: CBT-I (Behavioral)
combined aerobic physical activity and CBT-I
combined aerobic physical activity and cognitive behaviour therapy for insomnia
干预措施: Combined aerobic physical activity and CBT-I (Behavioral)
结局指标
主要结局
Average Pain severity
时间窗: Baseline and 2, 6 (primary time-point) and 12 months
Average pain severity at the designated study site will be measured using a 0-10 Numerical Rating Scale, with higher scores indicating greater pain. Assessments will be conducted at baseline and at 2, 6, and 12 months. Primary intervention efficacy will be evaluated by between-group differences in change in average NRS pain from baseline to 6 months.
次要结局
- Worst pain severity(Baseline and 2, 6 and 12 months)
- Pain interference (PROMIS Short Form 8a)(Baseline, 2 mths, 6 and 12 months.)
- Health-related quality of life (EQ-5D-5L)(Baseline, 2 mths, 6 and 12 months.)
- Insomnia (Insomnia Severity Index)(Baseline, 2 mths, 6 and 12 months.)
- Sleep-related impairment (PROMIS-Sleep-related Impairment Short Form 8a)(Baseline, 2 mths, 6 and 12 months.)
- Physical Function (PROMIS-Physical Function Short Form 8c v2.0)(Baseline, 2 mths, 6 and 12 months.)
- Satisfaction with the intervention(2 mths, 12 months)