Mindful Miles Pilot Feasibility Study

NCT07462429 | Completed

• 1 other identifier: 25-2257
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Mindfulness; Physical Activity; Running; Patellofemoral Pain

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Change in pain-related fear as measured by the Tampa Scale of Kinesiophobia-11 Item (TSK-11)

  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)

  Collected at baseline and at the post-intervention visit, approximately 5 weeks apart

• Change in running cadence (steps per minutes)

  Collected at baseline and at the post-intervention visit, approximately 5 weeks apart

Study Arms (1)

Progressive Mindful Physical Activity Intervention

EXPERIMENTAL

Behavioral: Progressive Mindful Physical Activity

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.

Progressive Mindful Physical Activity Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Durham, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Behavior

Study Officials

• Hana Marmura, PhD, MPT

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Shelby Baez, PhD, LAT, ATC

  University of North Carolina, Chapel Hill

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 10, 2026
• Study Start: November 11, 2025
• Primary Completion: May 5, 2026
• Study Completion: May 5, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication.
• 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.

Locations

US (1)