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NCT06684587 | RECRUITING | Knee Osteoarthritis

Telehealth Exercise and Mindfulness for Pain in Osteoarthritis - Stage 1B
Sponsor:

Boston University Charles River Campus

Information provided by (Responsible Party):

Deepak Kumar

Brief 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.

Condition or disease

Knee Osteoarthritis

Intervention/treatment

Exercise Program

Mindful Exercise

Phase

NA

Detailed Description:

In this RCT, 62 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 62 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Telehealth Exercise and Mindfulness for Pain in Osteoarthritis: A Stage 1B Feasibility Study
Actual Study Start Date : 2025-04-24
Estimated Primary Completion Date : 2026-09
Estimated Study Completion Date : 2027-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 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
Telehealth Exercise and Mindfulness for Pain in Osteoarthritis - Stage 1B

Location Details

NCT06684587

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Massachusetts

Boston University

Boston, Massachusetts, United States, 02215