Clinical trial NCT06684587: Telehealth Exercise and Mindfulness for Pain in Osteoarthritis - Stage 1B
Official title: Telehealth Exercise and Mindfulness for Pain in Osteoarthritis: A Stage 1B Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Telehealth
Exercise
Mindfulness
Pain
Feasibility
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 62
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel-arm randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Recruitment Rate
timeFrame: Throughout the recruitment process; up to 12 months from the start of the study
measure: Attendance
timeFrame: Throughout the intervention period (over 10-weeks)
measure: Retention Rate
timeFrame: Post-intervention visit (10-week)
measure: Adverse and serious adverse events
timeFrame: From first intervention session to week 22
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: Baseline, 5-week, 10-week, 16-week, 22-week
measure: Numeric Rating Scale - Nominated Activity
timeFrame: Weekly for 22 weeks
measure: Participant Feedback Survey
timeFrame: 5-week, Post-intervention visit (10-week), Follow-up visit (22-week)
measure: Satisfaction Scale
timeFrame: Post-intervention visit (10-week), Follow-up visit (22-week)
measure: Pain Catastrophizing Scale
timeFrame: Baseline, 5-week, 10-week, 16-week, 22-week
measure: Participant Global Impression of Change
timeFrame: 5-week, 10-week, 16-week, 22-week
measure: Tampa Scale of Kinesiophobia
timeFrame: Baseline, 10-week, 22-week
measure: Global Mindfulness Scale
timeFrame: Baseline, 10-week, 22-week
Other outcomes:
measure: 7-meter Walk Test
timeFrame: Baseline,10-week
measure: Pain, Enjoyment, General Activity Scale
timeFrame: Baseline, 5-week, 10-week, 16-week, 22-week
measure: Patient Global Assessment of Osteoarthritis
timeFrame: Baseline, 5-week, 10-week, 16-week, 22-week
measure: Treatment History
timeFrame: Baseline, 5-week, 10-week, 16-week, 22-week
measure: Widespread Pain Index Symptom Severity Scale
timeFrame: Baseline, 5-week, 10-week, 16-week, 22-week
measure: Generalized Anxiety Disorder 7-item
timeFrame: Baseline, 5-week, 10-week, 22-week
measure: Patient Health Questionnaire 8-item
timeFrame: Baseline, 10-week, 22-week
measure: Homunculus
timeFrame: Baseline, 5-week, 10-week, 16-week, 22-week
measure: Arthritis Self Efficacy Scale
timeFrame: Baseline, 10-week, 22-week
measure: Fear Avoidance Beliefs Questionnaire - Physical Activity
timeFrame: Baseline,10-week
measure: Whole Person Health Index
timeFrame: Baseline,10-week
measure: Daily life gait speed
timeFrame: Baseline,10-week
measure: Daily life gait speed variability
timeFrame: Baseline,10-week
measure: Weekly medication use
timeFrame: Weekly for 22-weeks
measure: Weekly strengthening exercise
timeFrame: Weekly for 22-weeks
measure: Weekly aerobic exercise
timeFrame: Weekly for 22-weeks
measure: Weekly mindfulness practice (only for mindful exercise group)
timeFrame: Weekly for 22-weeks (only for mindful exercise group)
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
References:
citation: Shah N, Morone N, Kim E, Ellis TD, Cohn E, LaValley MP, Kumar D. Telehealth mindful exercise for people with knee osteoarthritis: A decentralized feasibility randomized controlled trial. Osteoarthr Cartil Open. 2024 Jun 19;6(3):100494. doi: 10.1016/j.ocarto.2024.100494. eCollection 2024 Sep.