Telehealth Exercise and Mindfulness for Pain in Osteoarthritis - Stage 1B
Key facts
- Who runs it
- Boston University Charles River Campus
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Active, not recruiting
- People taking part
- 66 people, planned
- Started
- 24 Apr 2025
- Expected to end
- Aug 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Exercise Program
- Mindful Exercise
- Record updated
- 17 September 2026
Who can take part
- Age
- 50 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Any knee surgery in the previous 6 months
- 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
- Suspected or known drugs or alcohol abuse
- 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
- Neurological conditions that impacts motor functioning (e.g., stroke, Parkinson's disease, Alzheimer's disease, Multiple Sclerosis, diabetic neuropathy, etc)
- Contraindications to exercise
- Other pain in lower back or legs that is greater than knee pain
- Joint replacement in either hip or ankle
- Pregnancy (self-report)
- Participation in another clinical trial for any joint or muscle pain
Where in United States
- Boston UniversityBoston, United States
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Group TX (Telehealth Exercise)Existing treatment, for comparison
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.
Treatment: Exercise Program
- Group TMX (Telehealth Exercise and Mindfulness)Treatment being tested
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.
Treatment: Mindful Exercise
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Telehealth Exercise and Mindfulness for Pain in Osteoarthritis: A Stage 1B Feasibility Study
- Record updated
- 17 September 2026