Telehealth Exercise and Mindfulness for Pain in Osteoarthritis - Stage 1B (NCT06684587) | Clinical Trial Compass
RecruitingNot Applicable
Telehealth Exercise and Mindfulness for Pain in Osteoarthritis - Stage 1B
United States66 participantsStarted 2025-04-24
Plain-language summary
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.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
* BMI\<40
* 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
Exclusion Criteria:
* 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 …
What they're measuring
1
Recruitment Rate
Timeframe: Throughout the recruitment process; up to 12 months from the start of the study
2
Attendance
Timeframe: Throughout the intervention period (over 10-weeks)
3
Retention Rate
Timeframe: Post-intervention visit (10-week)
4
Adverse and serious adverse events
Timeframe: From first intervention session to week 22