Purpose

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.

Condition

Eligibility

Eligible Ages
Over 50 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Parallel-arm randomized controlled trial
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
For some of the outcomes that are not patient-reported, researchers collecting the at the post-intervention visit timepoint will be blinded to group allocation.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Group TX (Telehealth Exercise)
Participants in this group will receive supervised, group-based exercise two times a week for 12 weeks via telehealth.
  • Behavioral: Exercise
    A 12-week exercise program focused on strengthening and neuromuscular exercises for knee osteoarthritis. The program will be delivered twice a week for 12 weeks by real-time videoconferencing in a group setting. Participants in both the intervention and control group will receive this exercise program.
Experimental
Group TMX (Telehealth Exercise and Mindfulness)
Along with the 12-week group exercise program, participants in this group will receive additional mindfulness training that will be supervised, group-based and via telehealth for 12-weeks
  • Behavioral: Mindful Exercise program
    This is a 12-week program delivered by a mindfulness expert by real-time videoconferencing in a group setting. This program will be provided along with a12-week exercise program. The goal of this program is to teach participants how to be mindful during exercises. Each mindfulness sessions will be 30-45 min long. In the first 6 weeks, participants will be introduced to the concept of mindfulness meditation separately before the exercise sessions. In the later weeks, the mindfulness and exercise sessions will be combined such that participants will be able to practice mindfulness during the exercise program.

Recruiting Locations

Movement and Applied Imaging Lab, Boston University
Boston, Massachusetts 02215
Contact:
Nirali Shah
857-310-1084
nirali05@bu.edu

More Details

Status
Recruiting
Sponsor
Boston University Charles River Campus

Study Contact

Deepak Kumar, PT, PhD
617-358-3037
kumard@bu.edu

Detailed Description

In this RCT, the feasibility of a 12-week telehealth mindful exercise intervention compared to a telehealth exercise only intervention for people with knee osteoarthritis (OA) will be assessed. Forty adults with knee osteoarthritis will be assigned to either an exercise arm or mindful exercise arm. Both interventions will be delivered via real-time videoconferencing in a group setting. During the study period, all participants will be administered questionnaires for self-reported symptoms, and assessed for functional tests, muscle strength, physical activity, and pain sensitivity. At the end of 12-weeks, 10 participants will be purposively sampled from each arm (n=20 total) for individual interviews to determine acceptability of the telehealth interventions. At 18-weeks, participant will complete questionnaires on pain, function, etc. Feasibility of the intervention will be determined post-intervention by outcome measures such as recruitment rate, retention rate, and adherence.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.