NCT07689916

Brief Summary

This study aims to identify biomechanical risk factors associated with common running-related injuries in recreational runners using machine learning analysis. It also aims to evaluate whether a precision exercise intervention based on these risk factors can improve injury-related biomechanical and kinematic outcomes. The main questions it aims to answer are: Which biomechanical features identified by machine learning are associated with the occurrence of common running-related injuries, including medial tibial stress syndrome (MTSS), patellofemoral pain (PFP), and chronic Achilles tendinopathy? Whether a precision exercise intervention based on these risk factors can improve injury-related biomechanical and kinematic characteristics? Participants will: Undergo baseline biomechanical assessment during running, including motion capture, ground reaction force, and surface electromyography Be prospectively followed for 6 months to record the occurrence of running-related injuries Be classified into injury groups based on diagnosis, including MTSS, PFP, and chronic Achilles tendinopathy Following the completion of the follow-up period, participants will be allocated to either a precision multidimensional intervention group, a precision exercise intervention group, or a control group. The precision multidimensional intervention group will receive patient education in addition to an 8-week intervention program, including stretching, strength training, and real-time movement feedback. The precision exercise intervention group will receive the same 8-week intervention program, consisting of stretching, strength training, and real-time movement feedback. The control group will maintain their habitual physical activity patterns without receiving any additional intervention. Participants will be reassessed after the intervention and at the 3-month follow-up using the same biomechanical testing protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
Last Updated

July 8, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

June 25, 2026

Last Update Submit

July 1, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Incidence of running-related injuries

    Occurrence of running-related injuries during the follow-up period, including medial tibial stress syndrome (MTSS), patellofemoral pain (PFP), and chronic Achilles tendinopathy, based on predefined clinical diagnostic criteria.

    Through study completion, an average of 1 year

  • Mechanical Loading of Lower Limb

    Peak mechanical loading of the Achilles tendon, tibia, and patellofemoral joint during running, estimated using musculoskeletal modeling and biomechanical analysis.

    Through study completion, an average of 1 year

Secondary Outcomes (5)

  • Trunk muscle force

    Through study completion, an average of 1 year

  • Hip muscle force

    Through study completion, an average of 1 year

  • Thigh muscle force

    Through study completion, an average of 1 year

  • Lower Leg Muscle Force

    Through study completion, an average of 1 year

  • Foot muscle force

    Through study completion, an average of 1 year

Study Arms (3)

Multidimensional Precision Intervention Group

EXPERIMENTAL

Participants receive an 8-week intervention program based on patient education combined with stretching, strength training, and real-time movement feedback.

Behavioral: Multidimensional Precision Intervention

Precision Exercise Intervention Group

EXPERIMENTAL

Participants receive an 8-week precision exercise program including stretching, strength training, and real-time movement feedback.

Behavioral: Precision Exercise Intervention

Control Group

NO INTERVENTION

Participants maintain their usual physical activity and receive no additional intervention during the study period.

Interventions

Participants receive an 8-week precision exercise program including stretching, strength training, and real-time movement feedback based on machine learning-identified biomechanical risk factors. In addition, participants receive structured patient education in the multidimensional intervention group.

Multidimensional Precision Intervention Group

Participants receive an 8-week precision exercise program including stretching, strength training, and real-time movement feedback based on biomechanical risk factors identified by machine learning.

Precision Exercise Intervention Group

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male recreational runners (without formal professional training)
  • Weekly running distance greater than 10 km
  • No history of lower-limb injury within the past 3 months

You may not qualify if:

  • Other musculoskeletal or soft-tissue injuries, including arthritis, muscle injury, or meniscal injury
  • History of lower-limb surgery
  • Regular participation in contact or high-impact sports

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Key Laboratory of Adolescent Health Assessment and Exercise Intervention of Ministry of Education, East China Normal University

Shanghai, Minhang District, 200241, China

Location

MeSH Terms

Conditions

Medial Tibial Stress SyndromePatellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesLeg InjuriesWounds and InjuriesJoint Diseases

Study Officials

  • Zeyi Zhang

    East China Normal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 8, 2026

Study Start

August 1, 2025

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

July 8, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

This study is part of a larger ongoing research project. As the project has not yet been completed, individual participant data are currently not available for sharing.

Locations