Patellofemoral Pain, PFPNCT07462429
Mindful Miles Pilot Feasibility Study
A study testing Progressive Mindful Physical Activity in people with Patellofemoral Pain, PFP and Patellofemoral Pain Syndrome, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patellofemoral Pain, PFP, Patellofemoral Pain Syndrome, Patellofemoral Pain
- What is being tested?
- Progressive Mindful Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2025to 5 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Durham, North Carolina, 27599
About this study
Official title: 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.
Read more
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.
Read the 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)
- Being tested
- Progressive Mindful Physical Activity
- Keywords
- Mindfulness, Physical Activity, Running, Patellofemoral Pain
- Medical subject headings
- Patellofemoral Pain Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Mindful Physical ActivityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Mindful Physical Activity Intervention | Experimental | Not described Receives: Behavioral: Progressive Mindful Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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).
Measured: 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.
Measured: Collected at baseline and at the post-intervention visit, approximately 5 weeks apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start11 Nov 2025
- Primary completion5 May 2026
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain, PFPStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Hana Marmura, PhD, MPT, Principal investigator, University of North Carolina, Chapel HillShelby Baez, PhD, LAT, ATC, Study director, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462429
- Sponsor's protocol ID
- 25-2257
- Status last verified
- Feb 2026
- First submitted
- 4 Mar 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Miles Pilot Feasibility Study for Individuals With Patellofemoral Pain
- ClinicalTrials.gov ID
- NCT07462429
- Acronym / sponsor ID
- 25-2257
- Conditions
- Patellofemoral Pain, PFP, Patellofemoral Pain Syndrome, Patellofemoral Pain, Patellofemoral Pain (PFPS)
- Keywords
- Mindfulness, Physical Activity, Running, Patellofemoral Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Progressive Mindful Physical Activity Intervention | Experimental | Behavioral: Progressive Mindful Physical Activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Mindful Physical ActivityParticipants 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. | Behavioural | Progressive Mindful Physical Activity Intervention |
Primary outcome
Number of participants recruited to enroll in the study per week.
Time frame: Through study completion, a total of approximately 6 months.
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.
Percentage of interested and eligible participants who enrolled in the study
Time frame: Through study completion, a total of approximately 6 months
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.
Percentage of participants retained in the study
Time frame: Through study completion, a total of approximately 6 months
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.
Mean Acceptability Score
Time frame: Collected post-intervention, approximately 5 weeks after the baseline visit
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.
3 secondary outcomes
Change in pain-related fear as measured by the Tampa Scale of Kinesiophobia-11 Item (TSK-11)
Time frame: 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)
Time frame: Collected at baseline and at the post-intervention visit, approximately 5 weeks apart
Change in running cadence (steps per minutes)
Time frame: Collected at baseline and at the post-intervention visit, approximately 5 weeks apart
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Patellofemoral Pain, PFP
Not yet recruiting
The Effect of a Treatment Protocol Focused on Neuromuscular Control Exercises on Pain and Function in a Subgroup of Individuals With Patellofemoral Pain
Patellofemoral Pain
Active, not recruiting
Gait Retraining for Runners With Patellofemoral Pain
Patellofemoral Pain, PFP
Active, not recruiting
Telerehabilitation for Patellofemoral Pain
Patellofemoral Pain, PFP
Not yet recruiting
Comparison Between Foot Segment Mulligan Mobilization and Ilium Mulligan Mobilization in Treatment Patellofemoral Pain Patients With Flatfeet: a Randomized Controlled Comparative Study
Patellofemoral Pain, PFP, Flatfeet
Recruiting
Effects of Kinesio Taping Versus McConnell Taping on Clinical Outcomes in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome, Anterior Knee Pain Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hana Marmura, PhD, MPT principal investigator
University of North Carolina, Chapel Hill
Shelby Baez, PhD, LAT, ATC study director
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Mindful Physical Activity in people with Patellofemoral Pain, PFP and Patellofemoral Pain Syndrome, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.