Telehealth Exercise and Mindfulness for Pain in Osteoarthritis: A Stage 1B Feasibility Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• Meet National Institute for Health and Clinical Excellence clinical guidelines for knee osteoarthritis (i.e., age ≥ 50 years, presence of activity related pain, no morning knee stiffness or 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

Locations
United States
Massachusetts
Boston University
RECRUITING
Boston
Contact Information
Primary
Deepak Kumar, PT, PhD
kumard@bu.edu
617-358-3037
Backup
Ehyun Kim, MS
kimawc@bu.edu
617-358-8142
Time Frame
Start Date: 2025-04-24
Estimated Completion Date: 2027-08
Participants
Target number of participants: 62
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Boston University Charles River Campus

This content was sourced from clinicaltrials.gov