Clinical Trials Directory

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

TypeNameDescription
BEHAVIORALExercise ProgramIn this 10-week intervention, participants will be given strengthening exercises and neuromuscular re-education exercises.
BEHAVIORALMindful ExerciseIn 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.