Clinical Trial

Mindful Miles Pilot Feasibility Study

Completed
View on ClinicalTrials.gov →
Summary
The goal of this single-arm pilot study is to examine the feasibility, acceptability, and preliminary efficacy of a progressive outdoor mindful physical activity intervention delivered via the Headspace mobile application for individuals with patellofemoral pain. AIM 1: Determine the feasibility and acceptability of the mindful activity intervention. AIM 2: Determine the preliminary efficacy of the mindful running intervention to improve the primary outcome of (2a) anterior knee pain, and secondary outcomes of (2b) kinesiophobia and (2c) running cadence and vertical forces (gait kinematics) in individuals with PFP. Our central hypothesis is that the intervention will be feasible and acceptable and will improve pain, kinesiophobia (injury-related fear), and running cadence (steps per minute) in individuals with patellofemoral pain. Participants will complete a three-phase progressive mindful physical activity intervention that involves: Phase 1: Introduction to mindfulness Phase 2: Guided mindful running Phase 3: Mindful running.
Protocol Amendment History 2 changes
critical Trial completed 2026-05-20
notable Enrollment reduced: 20 -> 18 participants 2026-05-20
Trial Details
NCT Number NCT07462429
Lead Sponsor University of North Carolina, Chapel Hill
Collaborators: Canadian Institutes of Health Research (CIHR)
Conditions Patellofemoral Pain, PFP, Patellofemoral Pain Syndrome, Patellofemoral Pain, Patellofemoral Pain (PFPS)
Enrollment 18 participants
Start Date 2025-11-11
Primary Completion 2026-05-05 (estimated)
Study Completion 2026-05-05 (estimated)
Updated on ClinicalTrials.gov 2026-05-19