Mindfulness + Physical Activity for ACL Reconstruction
(Mind in Motion Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to learn whether a 6-week mobile-delivered intervention combining mindfulness meditation (Headspace) and personalized, wearable-derived physical activity goals (Oura Ring) can be feasibly delivered to young people who are 1-5 years post-anterior cruciate ligament reconstruction (ACLR) and who have elevated fear of reinjury. The main questions it aims to answer are:
* Can the Mind in Motion intervention be implemented with acceptable rates of recruitment, retention, engagement (mindfulness session completion, Oura Ring wear), and participant-rated acceptability?
* On days following a completed mindfulness session, do participants report lower anticipated fear of movement and show higher objectively measured moderate-to-vigorous physical activity (MVPA), compared with other days?
Participants will:
* Complete two brief in-person visits (approximately 1 week apart) that frame a 6-week home-based intervention period, followed by a remote assessment 4 weeks after the intervention ends.
* Wear a research-grade activPAL accelerometer on the thigh for 7 days before and 7 days after the intervention to measure objective physical activity.
* During the 6-week intervention, complete five 10-minute Headspace mindfulness sessions per week, wear an Oura Ring daily to receive personalized daily activity goals, and complete brief twice-daily check-ins (ecological momentary assessments) about fear, mood, and activity.
* Complete standard questionnaires about injury-related fear, psychological readiness for activity, and knee function/symptoms at baseline, mid-intervention, immediately after the intervention, and at a 4-week follow-up.
* Complete a brief audio-recorded exit interview describing their experience with the intervention.
This is a single-arm, single-site feasibility study; there is no control group and no randomization. Findings will inform the design of a future multisite randomized controlled trial.
Who Is on the Research Team?
Christopher Kuenze, PhD
Principal Investigator
University of Virginia
Are You a Good Fit for This Trial?
This trial is for young people who had ACL reconstruction surgery 1-5 years ago and still have a high fear of reinjury. Participants should be able to use mobile apps and wearable devices, attend two brief in-person visits, and complete online check-ins.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Mind in Motion
Trial Overview
The study tests if a 6-week program combining mindfulness meditation (using Headspace) and personalized physical activity goals (with an Oura Ring) can be delivered successfully after ACL surgery. All participants receive the intervention; there is no control group.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All enrolled participants receive the Mind in Motion intervention; there is no control or comparison arm. Over a 6-week home-based period, participants complete five 10-minute Headspace mindfulness sessions per week (drawn sequentially from the Basics, Sports Rehabilitation, and Sport Recovery courses) and wear an Oura Ring daily to receive a personalized daily moderate-to-vigorous physical activity (MVPA) goal, generated each day from the 60th percentile of the participant's own preceding 9 valid days of Oura-measured MVPA. Throughout the intervention, participants also complete brief twice-daily ecological momentary assessments of anticipated and experienced fear of movement, mood, soreness, and perceived exertion. The intervention is bracketed by two in-person visits (orientation/baseline and post-intervention) and includes a remote mid-intervention assessment and a remote 4-week post-intervention retention assessment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor
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