Telehealth Exercise and Mindfulness for Pain in Osteoarthritis

Study Purpose

This is a parallel-arm mixed-methods randomized controlled trial to investigate the feasibility of telehealth delivered mindful exercise vs.#46; usual exercise interventions for people with knee osteoarthritis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 50 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05524116
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boston University Charles River Campus
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Deepak Kumar, PT, PhD
Principal Investigator Affiliation Boston University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Knee Osteoarthritis
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: 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.

Experimental: 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.

Interventions

Behavioral: - 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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Boston, Massachusetts

Status

Recruiting

Address

Movement and Applied Imaging Lab, Boston University

Boston, Massachusetts, 02215

Site Contact

Nirali Shah

[email protected]

857-310-1084