NCT07462429

Mindful Miles Pilot Feasibility Study

Mindful Miles Pilot Feasibility Study for Individuals With Patellofemoral Pain

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

One in four Americans suffer from chronic knee pain, leading to inactivity, poor health outcomes, and psychological distress. Patellofemoral pain (PFP) is the leading cause of knee pain in the United States and is not a self-limiting condition, meaning intervention is necessary to resolve or improve symptoms. Even with interventions to target biomechanics and strength, most young adults (40-90%) report unfavorable persistent symptoms 1-20 years after PFP diagnosis, significantly impacting long-term quality of life. Psychological distress is a central feature of PFP that may impact physical activity engagement, symptoms, and long-term health outcomes. Injury-related fear (i.e., fear of pain, painful movement, reinjury) is a common form of psychological distress in individuals with PFP and is associated with pain and disability. Higher levels of fear are also associated with reduced step rate (i.e., cadence), a key biomechanical variable linked to increased load and injury risk. Walking and running are primary modes of physical activity in both the general population and high performing athletes, often the first step in return to activity plans, and key behaviors in a healthy lifestyle. Despite the known negative consequences of kinesiophobia, few studies have examined psychologically focused interventions for individuals with PFP. Mindfulness, the ability to stay fully present without judgement, has been used to address chronic pain and kinesiophobia in this population. However, no studies have examined how integrating mindfulness during physical activity, when patients are most likely to experience pain and fear, can improve outcomes. This study will investigate the 1) feasibility and acceptability and 2) preliminary efficacy of a progressive and technology based mindful physical activity intervention to reduce knee pain/disability, reduce pain-related fear, and increase running cadence in adults with patellofemoral pain. Patients will complete a three phase progressive mindful physical activity using the Headspace mobile application including 1) Introduction to mindfulness: listening to the Headspace Pain Management Course at home (ten 10 minute sessions), 2) Guided mindful running: three runs on separate days (12, 15, and 20 minutes respectively) listening to guided running audio scripts from Headspace, and 3) Mindful running: three runs on separate days (12, 15, and 20 minutes respectively) with no audio input, integrating learned mindfulness and pain management skills.

Conditions

• Patellofemoral Pain, PFP
• Patellofemoral Pain Syndrome
• Patellofemoral Pain
• Patellofemoral Pain (PFPS)

Interventions

Type	Name	Description
BEHAVIORAL	Progressive Mindful Physical Activity	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.

Timeline

• Start date: 2025-11-11
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

1 site across 1 country: United States