NCT07408700

Brief Summary

Background. Patellofemoral pain (PFP) is one of the most common causes of knee pain in recreational runners and is exacerbated by activities that load the patellofemoral joint. Although biomechanical differences between running surfaces and elevation profiles have been documented, the influence of terrain type and training load on PFP in non-professional runners remains poorly defined. Objective. To examine the association between predominant training terrain and the presence of PFP in non-professional runners, and to describe its functional severity. Secondarily, to analyze the relationship between terrain exposure, elevation, training load and volume with PFP, as well as the potential influence of previous knee history and footwear rotation. Methods. An observational, analytical, cross-sectional study conducted through an online survey targeting recreational runners. The primary outcome will be the presence of patellofemoral pain, defined according to the 2016 International Consensus, and functional severity will be assessed using the Spanish-validated Kujala Anterior Knee Pain Scale. Exposures will include the percentage of kilometers run on each terrain type, positive and negative elevation gain, internal load (session rating of perceived exertion × duration), training volume, and running pace. Potential confounders will include age, sex, body mass index, running experience, training frequency, previous knee history, lower-limb strength, accumulated elevation gain, and footwear rotation. Descriptive analyses and logistic regression models will be performed to identify independent associations. Expected results. To estimate the prevalence of PFP in recreational runners, identify terrain- and load-related factors associated with its occurrence, and define a predictive model to inform prevention strategies and training planning.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 12, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2026

Completed
Last Updated

May 1, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 6, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

Patellofemoral Pain SyndromeRunningSurfacesExerciseWorkloadEpidemiology

Outcome Measures

Primary Outcomes (1)

  • Measurement of patellofemoral pain over the previous three months.

    This variable will be defined according to the International Consensus on Patellofemoral Pain. Participants will be classified as positive cases if they report anterior or retropatellar knee pain in the previous three months, exacerbated by at least one weight-bearing, knee-flexion activity (e.g., running, stair ambulation, slopes, or squatting), with a duration of ≥4 weeks or ≥2 episodes during that period

    Screening visit

Secondary Outcomes (7)

  • Measurement of functional severity of patellofemoral pain

    Screening visit

  • Measurement of terrain exposure (previous 3 months)

    Screening visit

  • Measurement of weekly positive and negative elevation gain

    Screening visit

  • Measurement of the percentage of downhill kilometers

    Screening visit

  • Measurement of training intensity and internal load (previous 4 weeks)

    Screening visit

  • +2 more secondary outcomes

Other Outcomes (9)

  • Measurement of age

    Screening visit

  • Measurement of gender

    Screening visit

  • Measurement of body mass index

    Screening visit

  • +6 more other outcomes

Study Arms (1)

Observational group

Non-professional / recreational adult runners who train regularly and perform the majority of their training on asphalt, trail, or mountain terrain.

Other: Runner sample

Interventions

Runners with lower or different exposure to these factors: other predominant terrain types (e.g., asphalt or trail), lower accumulated elevation gain, and/or lower levels of internal load and training volume.

Observational group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult non-professional / recreational runners who train regularly and perform the majority of their training on asphalt, trail, or mountain terrain.

You may qualify if:

  • Participants aged 18 years or older.
  • Recreational (non-professional) runners.
  • Have run regularly over the previous 3 months (at least once per week).
  • Are able to report their predominant training terrain (asphalt, trail, or mountain).
  • Have or do not have patellofemoral pain.
  • Have provided written informed consent.

You may not qualify if:

  • Have had a complete cessation of running for ≥4 weeks within the previous 3 months.
  • Have undergone major knee or ankle surgery within the past year.
  • Have a diagnosis of conditions that clearly alter gait or running pattern.
  • Present severe knee disorders that preclude accurate assessment of patellofemoral pain.
  • Have incomplete questionnaires for essential variables (terrain type, patellofemoral pain, AKPS, training load, or training volume)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Oviedo

Oviedo, Principality of Asturias, 33006, Spain

Location

MeSH Terms

Conditions

Patellofemoral Pain SyndromeMotor Activity

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesBehavior

Study Officials

  • Rubén Cuesta-Barriuso, PhD

    Universidad de Oviedo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 13, 2026

Study Start

February 12, 2026

Primary Completion

April 3, 2026

Study Completion

May 11, 2026

Last Updated

May 1, 2026

Record last verified: 2026-02

Locations