Telehealth Exercise and Mindfulness for Pain in Osteoarthritis: A Stage 1B Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Adverse and serious adverse events
研究概览
简要总结
The goal of this randomized controlled trial (RCT) is to test the feasibility of an 10-week telehealth mindful exercise intervention compared to a telehealth exercise only intervention for people with knee osteoarthritis (OA). This RCT will be fully digital with all recruitment, assessments, and intervention being conducted remotely.
详细描述
In this RCT, 66 adults with knee osteoarthritis will be assigned to either an exercise arm or mindful exercise arm. Both interventions will be delivered via videoconferencing in a group setting. In both groups, participants will receive a supervised session twice a week for 10 weeks. Participants will also receive a home program. During the study period, participants will be asked to remotely complete brief surveys every week and longer surveys on pain, function, mood, and other symptoms at baseline, week 5, week 10, week 16, and week 22. These surveys will be about pain, function, mood, and other symptoms. Participants will complete digital wearable-sensor based assessments at baseline and week 10. Participants will also be asked to complete brief surveys each week during the study. Feasibility of the intervention will be determined post-intervention by outcome measures such as recruitment rate, retention rate, and adherence.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet National Institute for Health and Clinical Excellence clinical guidelines for knee osteoarthritis (i.e., age ≥ 50 years, presence of activity related pain, no morning knee stiffness or presence of morning knee stiffness ≤ 30 minutes)
- •Knee pain on most days for 3 months or more
- •Average overall knee pain severity of ≥ 4 on an 11-point numeric rating scale over last 7 days, at least 2 weeks apart
- •Able to attend remote sessions
- •Can speak and understand English at a sufficient level to understand the study procedures and informed consent.
- •Available for study duration
排除标准
- •Contraindications to exercise
- •Other pain in lower back or legs that is greater than knee pain
- •Received physical therapy treatment for knee OA in the past 6 months or currently receiving physical therapy
- •Received any mindfulness programs such as Tai Chi, meditation, etc. in the past 6 months or currently receiving such program
- •Currently receiving chemotherapy or radiation therapy for cancer except non-melanoma skin cancer
- •History of other disease that may involve the index joint including inflammatory joint disease such as rheumatoid arthritis, seronegative spondyloarthropathy (eg, ankylosing spondylitis, psoriatic arthritis, inflammatory bowel disease related arthropathy), crystalline disease (eg, gout or pseudogout), lupus erythematosus, knee joint infections, Paget's disease affecting the knee, or knee joint tumors.
- •Any knee surgery in the previous 6 months
- •Joint replacement in either hip or ankle
- •Previous knee osteotomy partial or total knee replacement in either knee
- •Planned major treatment for knee OA (e.g., surgery, injections, physical therapy) during the study period
- •Planned major surgery in the next 6 months
- •Corticosteroid or hyaluronic acid injections in either knee in the previous 3 months
- •Neurological conditions that impacts motor functioning (e.g., stroke, Parkinson's disease, Alzheimer's disease, Multiple Sclerosis, diabetic neuropathy, etc).
- •Pregnancy (self-report)
- •Participation in another clinical trial for any joint or muscle pain
- •Suspected or known drugs or alcohol abuse
研究组 & 干预措施
Group TX (Telehealth Exercise)
Participants in this group will receive a group-based, supervised exercise session twice a week for 10 weeks along with a structured home exercise program. These sessions will be delivered via Boston University HIPAA-compliant Zoom videoconferencing software.
干预措施: Exercise Program (Behavioral)
Group TMX (Telehealth Exercise and Mindfulness)
Participants in this group will receive a group-based, supervised, integrated mindfulness and exercise program twice a week for 10 weeks along with a structured home program. Similar to the exercise intervention, these sessions will be delivered via Boston University HIPAA-compliant Zoom videoconferencing software.
干预措施: Mindful Exercise (Behavioral)
结局指标
主要结局
Adverse and serious adverse events
时间窗: From first intervention session to week 22
\# of intervention related adverse or serious adverse events
Recruitment Rate
时间窗: Throughout the recruitment process; up to 12 months from the start of the study
Proportion of participants that are recruited for the study
Attendance
时间窗: Throughout the intervention period (over 10-weeks)
Proportion of sessions attended.
Retention Rate
时间窗: Post-intervention visit (10-week)
Proportion of participants who complete patient-reported outcome surveys.
次要结局
- Knee Injury and Osteoarthritis Outcome Score(Baseline, 5-week, 10-week, 16-week, 22-week)
- Numeric Rating Scale - Nominated Activity(Weekly for 22 weeks)
- Participant Feedback Survey(5-week, Post-intervention visit (10-week), Follow-up visit (22-week))
- Satisfaction Scale(Post-intervention visit (10-week), Follow-up visit (22-week))
- Pain Catastrophizing Scale(Baseline, 5-week, 10-week, 16-week, 22-week)
- Participant Global Impression of Change(5-week, 10-week, 16-week, 22-week)
- Tampa Scale of Kinesiophobia(Baseline, 10-week, 22-week)
- Global Mindfulness Scale(Baseline, 10-week, 22-week)
研究者
Deepak Kumar
Associate Professor
Boston University Charles River Campus