Telehealth Exercise and Mindfulness for Pain in Osteoarthritis - Stage 1B

Study Purpose

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.

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 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

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.

NCT06684587
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.

N/A
Principal Investigator Affiliation N/A
Agency Class

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

Other
Overall Status Not yet recruiting
Countries United States
Conditions

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

Knee Osteoarthritis
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Group TX (Telehealth Exercise)

Participants in this group will receive a group-based, supervised exercise session twice a week for 10 weeks along with a structured home exercise program. These sessions will be delivered via Boston University HIPAA-compliant Zoom videoconferencing software.

Experimental: Group TMX (Telehealth Exercise and Mindfulness)

Participants in this group will receive a group-based, supervised, integrated mindfulness and exercise program twice a week for 10 weeks along with a structured home program. Similar to the exercise intervention, these sessions will be delivered via Boston University HIPAA-compliant Zoom videoconferencing software.

Interventions

Behavioral: - Exercise Program

In this 10-week intervention, participants will be given strengthening exercises and neuromuscular re-education exercises.

Behavioral: - Mindful Exercise

In this 10-week intervention, mindfulness meditation will be integrated with strengthening and neuromuscular exercises recommended for knee osteoarthritis.

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 University, Boston, Massachusetts

Status

Address

Boston University

Boston, Massachusetts, 02215

Site Contact

Deepak Kumar, PT, PhD

[email protected]

617-358-3037