Telehealth Exercise and Mindfulness for Pain in Osteoarthritis (TEMPO)

Boston University Charles River Campus

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Behavioral: Mindful Exercise program; Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05524116

6492

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 45 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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, 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 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups

Group TX (Telehealth Exercise)

Active Comparator group

Description:

Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth.

Treatment:

Behavioral: Exercise

Group TMX (Telehealth Exercise and Mindfulness)

Experimental group

Description:

Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth.

Treatment:

Behavioral: Mindful Exercise program