Mindful Miles Pilot Feasibility Study

Part of paid clinical trials in Durham, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT07462429
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Progressive Mindful Physical Activity — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Nov 11, 2025
Status verified
Feb 2026
Primary completion
May 5, 2026
Completion
May 5, 2026

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Progressive Mindful Physical Activity Intervention

Primary Outcome Measure

Number of participants recruited to enroll in the study per week. [ Time Frame: Through study completion, a total of approximately 6 months. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillDurhamNorth Carolina27599-

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By research site
University of North Carolina at Chapel Hill· Durham, NC

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