Mindfulness + Physical Activity for ACL Reconstruction

(Mind in Motion Trial)

CK
Overseen ByChristopher Kuenze, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Virginia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

CK

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

I had ACL reconstruction surgery 1 to 5 years ago.
I have been less physically active since my ACL reconstruction surgery.
I am medically cleared to participate in physical activities.
See 8 more

Exclusion Criteria

I have cognitive impairment.
I have a leg injury or condition that limits my physical activity.
My medical condition limits my ability to be physically active.
See 6 more

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

Group I: Mind in MotionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials
802
Recruited
1,342,000+