Trials / Recruiting
RecruitingNCT06684587
Telehealth Exercise and Mindfulness for Pain in Osteoarthritis - Stage 1B
Telehealth Exercise and Mindfulness for Pain in Osteoarthritis: A Stage 1B Feasibility Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- Sponsor
- Boston University Charles River Campus · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-04-24
- Primary completion
- 2026-09-01
- Completion
- 2027-08-01
- First posted
- 2024-11-12
- Last updated
- 2025-05-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06684587. Inclusion in this directory is not an endorsement.