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临床试验/NCT07689916
NCT07689916已完成不适用

Risk Factor Identification and Precision Exercise Intervention for Common Injuries in Recreational Runners Based on Machine Learning

Zeyi Zhang1 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2025年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
204
试验地点
1
主要终点
Incidence of running-related injuries

研究概览

简要总结

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.

详细描述

  1. Participants This prospective study recruited recreational runners from East China Normal University between November and December 2024 through poster advertisements and WeChat-based recruitment. Eligible participants were male recreational runners aged 18 to 30 years with a weekly running distance greater than 10 km and no history of lower-limb injury within the past three months. Exclusion criteria included: (1) the presence of other musculoskeletal or tissue injuries, such as arthritis, muscle injuries, or meniscal injuries; (2) a history of lower-limb surgery; and (3) regular participation in contact or high-impact sports, in order to minimize potential confounding effects from non-running-related musculoskeletal injuries.

A priori sample size estimation was performed using GPower software (GPower V3.1, Heinrich-Heine-Universität Düsseldorf, Germany). With a significance level of α = 0.05, statistical power of 0.80, and an effect size of 1.7, the minimum required sample size was estimated to be 170 participants. Considering an anticipated attrition rate of 20%, a total of 204 participants were ultimately recruited.

All participants were subsequently followed prospectively for 6 months and classified into four groups based on injury status: injury-free, chronic Achilles tendinopathy, MTSS, and PFP. Diagnostic criteria for chronic Achilles tendinopathy included: (1) insidious Achilles tendon pain aggravated by weight-bearing activities and worse in the morning and/or at the onset of activity; (2) pain and swelling located 2-6 cm proximal to the Achilles tendon insertion; (3) ultrasonographic evidence of tendon thickening >7 mm or >20% compared with the contralateral side; and (4) symptoms persisting for more than 3 months.

MTSS was defined as: (1) diffuse medial tibial pain during exercise with a palpation tenderness area of at least 5 cm; (2) symptom duration of at least 3 weeks; and (3) absence of stress fracture or other fractures on radiographic examination.

PFP was defined as: (1) pain around or behind the patella during at least two activities such as running, squatting, stair ascent/descent, prolonged sitting, jumping, or resisted knee extension; (2) pain not attributable to direct trauma and persisting for at least 3 months; and (3) a minimum pain intensity of ≥3 on a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates maximal pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Incidence of running-related injuries

时间窗: Through study completion, an average of 1 year

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.

Mechanical Loading of Lower Limb

时间窗: Through study completion, an average of 1 year

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

次要结局

  • 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)

研究者

发起方
Zeyi Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zeyi Zhang

Principal Investigator

East China Normal University

研究点 (1)

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