Mindful Miles Pilot Feasibility Study
Mindful Miles Pilot Feasibility Study for Individuals With Patellofemoral Pain
University of North Carolina, Chapel Hill
20 participants
Nov 11, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- years old or older
- Have access to an electronic mobile device that can be used to download the Headspace application
- Meet the established diagnostic criteria for patellofemoral pain: pain in/around the anterior knee, and reproduction of this pain with movements that load the patellofemoral joint (i.e., squatting, stair climbing or descent, running, or jumping) based on self-report
Exclusion Criteria6
- History of other musculoskeletal injuries in the past 6 months
- Previous lower extremity musculoskeletal surgery in the past 12 months
- Neuromuscular conditions that may affect movement,
- Currently pregnant
- Unable to attend in person study visits
- Unable or unwilling to run for up to 20 minutes
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Interventions
Participants will be given access to Headspace, which is a commercially available mobile application that provides evidence-based mindfulness and meditation tools. The mindful activity intervention will consist of three progressive phases, each lasting about 7-10 days: Introduction to Mindfulness, Guided Activity, and Mindful Activity, each lasting one week and outlined below. 1. Introduction to Mindfulness: Participants will be instructed to complete daily sessions from the Headspace "Pain Management" course. 2. Guided Activity: Participants will complete three runs using the following guided mindful running scripts provided by Headspace: "Run Easy", "Run Smart", and "Keep Running". The runs will be 12-, 15-, and 20-minutes, respectively. 3. Mindful Activity: Participants will complete three runs where they are encouraged to engage in mindfulness skills without any external input (i.e., no guided scripts or other audio). The runs will be 12-, 15-, and 20-minutes, respectively.
Locations(1)
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NCT07462429