Telehealth Exercise and Mindfulness for Pain in Osteoarthritis: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Attendance
研究概览
简要总结
This is a parallel-arm mixed-methods randomized controlled trial to investigate the feasibility of telehealth delivered mindful exercise vs. usual exercise interventions for people with knee osteoarthritis.
详细描述
In this RCT, the feasibility of an 8-week telehealth mindful exercise intervention compared to an 8-week telehealth exercise only intervention for people with knee osteoarthritis (OA) will be assessed. Forty adults with knee OA will be assigned to either a mindful exercise arm OR exercise arm. Both interventions will be delivered via real-time videoconferencing in a group setting (n=8-10 per group). All participants will be administered questionnaires for self-reported symptoms, mood, quality of life, etc. throughout the study period. Participants will be given the choice to opt in for in-person data collection visits wherein their physical function, muscle strength, sensitivity to painful stimuli, and brain function will be assessed before and at the end of the interventions. At the end of the 8-week interventions, 10 participants will be purposively sampled from each arm (n=20 total) for individual interviews to determine acceptability of the telehealth interventions. 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)
盲法说明
For some of the outcomes that are not patient-reported, researchers collecting the at the post-intervention visit timepoint will be blinded to group allocation.
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, 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 a 11-point numeric rating scale during previous week
- •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
结局指标
主要结局
Attendance
时间窗: post-intervention (at 8-weeks)
Proportion of sessions attended
Retention Rate
时间窗: post-intervention visit (at the end of 8-weeks)
Proportion of participants who complete patient-reported outcome surveys
Recruitment
时间窗: through the recruitment process, up to 6 months from the start of the study
Number of participants that are randomized for the study
Participant Feedback Survey
时间窗: 8-week
Custom scale measuring feedback on interventionists and interventions. Scores range from 0-4 (0 - Strongly Disagree, 1 - Disagree, 2 - Neither Agree no Disagree, 3 - Agree, and 4 - Strongly Agree)
Satisfaction Scale
时间窗: 8-week
Custom 4-item (0-10 scale) to determine satisfaction with individual components of the intervention (i.e.,, exercise, mindfulness, telehealth, and overall satisfaction). There are 4 items and each item is scored separately. Higher scores for each item mean greater satisfaction for that dimension.
次要结局
- Knee Injury and Osteoarthritis Outcome Score(baseline, 8-week, 14-week)
- Pain, Enjoyment, General Activity Scale(baseline, 8-week, 14-week)
- Numeric Rating Scale - Nominated Activity(baseline, 8-week, 14-week)
- Participant Global Impression of Change(8-week, 14-week)
- Patient Global Assessment of Osteoarthritis(baseline, 8-week, 14-week)
- Pain Catastrophizing Scale(baseline, 8-week)
- Widespread Pain Index Symptom Severity Scale(baseline, 8-week)
- Pain DETECT(baseline, 8-week)
- Patient Health Questionnaire 8-item(baseline, 8-week, 14-week)
- Cognitive and Affective Mindfulness Scale - Revised(baseline, 8-week, 14-week)
- Fear Avoidance Beliefs Questionnaire - Physical Activity(baseline, 8-week)
- Arthritis Self Efficacy Scale(baseline, 8-week)
- Chronic Pain Self-efficacy Questionnaire(baseline, 8-week)
研究者
Deepak Kumar
Assistant Professor
Boston University Charles River Campus