Telehealth Exercise and Mindfulness for Pain in Osteoarthritis

NCT ID: NCT05524116

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-04
• Study Completion Date: 2023-07-03

Brief Summary

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.

Detailed 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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group TX (Telehealth Exercise)

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

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

In this 8-week intervention, participants will be given recommended strengthening and neuromuscular exercises for knee osteoarthritis. Participants in both the intervention and control group will receive these exercises.

Group TMX (Telehealth Exercise and Mindfulness)

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

Group Type: EXPERIMENTAL

Mindful Exercise program

Intervention Type: BEHAVIORAL

In this 8-week intervention, components of Mindful Based Stress Reduction Program will be integrated with strengthening and neuromuscular exercises recommended for knee osteoarthritis. The goal of this program is to train participants how to be mindful during their exercises.

Interventions

Mindful Exercise program

In this 8-week intervention, components of Mindful Based Stress Reduction Program will be integrated with strengthening and neuromuscular exercises recommended for knee osteoarthritis. The goal of this program is to train participants how to be mindful during their exercises.

Intervention Type: BEHAVIORAL

Exercise

In this 8-week intervention, participants will be given recommended strengthening and neuromuscular exercises for knee osteoarthritis. Participants in both the intervention and control group will receive these exercises.

Intervention Type: BEHAVIORAL

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, 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University Charles River Campus

OTHER

Sponsor Role: lead

Responsible Party

Deepak Kumar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deepak Kumar, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Movement and Applied Imaging Lab, Boston University

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

6492

Identifier Type: -

Identifier Source: org_study_id