Mindful Miles Pilot Feasibility Study

Mindful Miles Pilot Feasibility Study for Individuals With Patellofemoral Pain

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.

Study Overview

• Status: Completed
• Conditions: Patellofemoral Pain Syndrome; Patellofemoral Pain (PFPS); Patellofemoral Pain; Patellofemoral Pain, PFP
• Intervention / Treatment: Behavioral: Progressive Mindful Physical Activity

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Progressive Mindful Physical Activity Intervention

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.; Introduction to Mindfulness: Participants will be instructed to complete daily sessions from the Headspace "Pain Management" course.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants recruited to enroll in the study per week.	Feasibility of the progressive mindful physical activity intervention will be assessed through the recruitment rate of adults with patellofemoral pain. Recruitment rate is defined as the number of participants recruited to enrol in the study per week.	Through study completion, a total of approximately 6 months.
Percentage of interested and eligible participants who enrolled in the study	Feasibility of the progressive mindful physical activity intervention will be assessed through established recruitment of adults with patellofemoral pain. Recruitment is defined as the percentage of participants who expressed interest in the study, were eligible, and enrolled in the study.	Through study completion, a total of approximately 6 months
Percentage of participants retained in the study	Feasibility of progressive mindful physical activity intervention will be assessed to determine participant retention. Retention is defined as the percentage of participants enrolled and who have completed all study measures through 5-weeks.	Through study completion, a total of approximately 6 months
Mean Acceptability Score	Acceptability of the progressive mindful physical activity intervention will be assessed via an acceptability survey, the Acceptability of the Intervention Measure (AIM) during the final assessment post-interventional week 5. Scores on the 4 item questionnaire range from 4 to 20. A mean score of 14 or greater will be interpreted as acceptable and a mean score of 16 or greater will be interpreted as high acceptability.	Collected post-intervention, approximately 5 weeks after the baseline visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain-related fear as measured by the Tampa Scale of Kinesiophobia-11 Item (TSK-11)	The is TSK-11 valid and reliable patient-reported outcome measure of injury and pain-related fear. Scores for the 11-item measure range from 11 to 44 with higher scores indicating higher levels of pain-related fear.	Collected at baseline and at the post-intervention visit, approximately 5 weeks apart
Change in knee pain and disability as measured by the Anterior Knee Pain Scale (AKPS)	The AKPS is a valid and reliable patient reported outcome measure of knee pain and function for individuals with patellofemoral pain. Scores for the 13 item measure range from 0 to 100, with higher scores indicating less knee pain and disability (better outcome).	Collected at baseline and at the post-intervention visit, approximately 5 weeks apart
Change in running cadence (steps per minutes)	Cadence (steps per minute) will be measured via a Stryd Foot Pod during each run. These pods attach to the participant's shoe and use movement to calculate cadence. Stryd Foot Pods have been confirmed as a valid tool to measure stepping cadence at walking, jogging, and running speeds.	Collected at baseline and at the post-intervention visit, approximately 5 weeks apart

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Hana Marmura, PhD, MPT, University of North Carolina, Chapel Hill; Study Director: Shelby Baez, PhD, LAT, ATC, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2025
• Primary Completion (Actual): May 5, 2026
• Study Completion (Actual): May 5, 2026

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Physical Activity; Mindfulness; Running; Patellofemoral Pain
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Behavior; Patellofemoral Pain Syndrome; Motor Activity
• Other Study ID Numbers: 25-2257

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The proposed research will include data from all patients regardless of successful completion of the proposed experimental protocol. The final dataset will include demographic information, self-reported knee pain/function, pain-related fear, and mindfulness questionnaires, and raw biomechanics data. Accompanying the data, a documentation file will be provided containing the methodological procedures used during the collection of the data and providing a key for all variables included within the final dataset. Prior to sharing this data, all personal identifying information will be removed to protect the rights and privacy of the participants.
• IPD Sharing Time Frame: Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication.
• IPD Sharing Access Criteria: IPD will only be shared provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No