Mindful Miles Pilot Feasibility Study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Hana Marmura, PhD, MPT · University of North Carolina, Chapel Hill

• Shelby Baez, PhD, LAT, ATC · University of North Carolina, Chapel Hill

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-11

Primary Completion

2026-05-05

Completion

2026-05-05

Countries

• United States

Study Locations