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Developing a Biopsychosocial Prediction Model for Running-Related Injuries

7 novembre 2026 aggiornato da: Hui-Ting Shih, National Yang Ming Chiao Tung University

Running-related injuries (RRI) are commonly reported by all levels of runners, which attenuate participation in running. Current evidence has suggested that RRI mostly occur in lower back and lower extremities, and they can be predicted by biopsychosocial factors. In regard of biomechanical factors, previous studies have found that RRI is related to tendon thickness, lower extremities muscle strength, navicular drop, joint alignment, range of motion, kinetic chain, functional movement, and footwear. Increased training volume and participation in marathon competitions are also associated with increased risk of injuries. Furthermore, recent studies has started to investigate influence of psychological aspects, and found correlations between running performance and risk of injuries and passion, grit, and endurance sports self-efficacy. In addition, social factors, such as, sleep and chronotype, may also affect runners' training schedule and recovery, indirectly influencing occurrence of RRI. However, current evidence on biopsychosocial predictors for RRI is limited. Therefore, this study aims to investigate biopsychosocial predictors for RRI in runners who plan to participate in marathons in six-month time. The study plan to recruit 100 participants and measure running habits, physical activity, passion, grit, endurance sports self-efficacy, sleep quality, and chronotype by questionnaires, and lower extremity tendon thickness, muscle thickness, and cross-sectional area by ultrasonography, and lower extremity muscle strength by hand-held dynamometer, and functional performance and running kinematics. The follow-ups will take place every month for consecutive 6 months after the first measurement, and any RRI occurs during the follow-ups will be recorded. The study is expected to assist in understanding mechanism of RRI, further improving sports prevention and treatment strategies.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Stimato)

100

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

      • Taipei, Taiwan, 106064
        • Reclutamento
        • 1F., No. 25, Ln. 112, Sec, Section 1, Anhe Rd, Da'an District
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Participants are community runners and are recruited through flyers, posters, and social media platforms, such as, Facebook, Instagram or LINE.

Descrizione

Inclusion Criteria:

  • Participants who run regularly at least 5 km per week, have consistently run for over 9 months, and will participate a half of full marathon competition in 6 months.

Exclusion Criteria:

  • Participants who (1) have musculoskeletal injuries in the recent 3 months; (2) have neurological disorders that would affect movement patterns; (3) are diagnosed with cardiovasculopulmanary or metabolic disease that are contraindications for middle and high intensity activities; (4) have autoimmune disorders; (5) have cancer; (6) are in fever or acute inflammation; or (7) are in pregnancy.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: CASE_CONTROL
  • Prospettive temporali: PROSPECTIVE

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
history of injuries
Lasso di tempo: Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement

Running-related injuries in recent 12 months/1 month and subsequent management or medical treatment. Running related injuries are defined as any pain and discomforts on muscles, skeletons, tendons, or ligaments that prevent or restrict participants from running for consecutive 7 days or 3 training sessions, irrespective of speed, distance, or training content.

Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement
running habits
Lasso di tempo: Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement

Running habits include running type, aims of running, running experience, participation in running class or club, training volume, longest training distance, average weekly running hours, average weekly running days, commonly running time at a day, footwear, participation in other sports, usage of insole or compressive garments, foot contact type, and registration of marathon competitions.

Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement
Level of Physical Activity
Lasso di tempo: Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement

Level of physical activity is measured by the International Physical Activity Questionnaire, including 9 questions that classify activities into 4 levels.

Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement
Passion
Lasso di tempo: Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement

Passion Scale measures participants' passion for running by a 12-item questionnaire, and the items are subcategorized into obsessive passion and harmony passion.

Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement
Endurance Sports Self-Efficacy
Lasso di tempo: Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement

Endurance Sports Self-Efficacy Scale consists of 11 items, with each one rated from 0 to 100 points. The scale measures how confident participants are in doing actions or skills that are important for endurance performance. 0 represent 'cannot do at all' and 100 represent 'completely certain can do'.

Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement
Grit
Lasso di tempo: Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement

GRIT Scale measures participants' perseverance and passion by a 12-item questionnaire. Each item is rated from 1 to 5, as 1 means 'not at all like me' and 5 means 'very much like me'.

Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement
Sleep Quality
Lasso di tempo: Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement

Sleep quality is measured by Pittsburg Sleep Quality Scale, which consists of 9 items. The scale assess sleep time, sleep disturbance, time to fall asleep, daytime dysfunction due to insufficient sleep, sleep efficiency, overall sleep quality, usage of medication for sleep. Highest score is 21 points, and receiving over 5 points indicates poor sleep quality.

Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement
Chronotype
Lasso di tempo: Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement

Chronotype is measured by Horne and Ostberg Morningness-Eveningness Questionnaire, which consists of 19 items. The questionnaire quantifies participants' preferred activity hours and their self-perceived performance during those hours.

Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement
Muscle Strength
Lasso di tempo: Baseline

Muscle strengths of hip abduction, hip clamshell, knee extension and knee flexion are measured by a hand-held dynamometer. The hip abduction and clamshell are performed in side-lying and knee extension and flexion are performed in sitting position. Participants are asked to resist against the dynamometer with their maximal efforts for 5 seconds for 3 times with 60-second rests between repetitions. Lever arms are measured with a tape measure.

Baseline
Navicular Drop
Lasso di tempo: Baseline

Navicular drop is measured by navicular drop test. Participants sits on a chair with their feet comfortably position on the ground. The height of the navicular tubercle from ground is measured on bilateral sides. After participants stand up with weight evenly distributed between both feet, and height of the navicular tubercle is measured again. The test is repeated for 3 times.

Baseline
Running Kinematics
Lasso di tempo: Baseline

Running kinematics are recorded by inertial measurement units and 2 smartphone. Inertial measurement units are placed on sacrum and bilateral tibial tuberosity. One smartphone is facing toward the side of treadmill and another one is right behind the participants, recording running videos from the sagittal and frontal views, respectively. Participants first run at a self-selected warm-up speed for 5 minutes with no recordings. After warm-up, participants run at the target speed for the marathon competition for 2 minutes. Video recordings starts at the beginning of the run and ends at the end of the run and inertial measurement units start recording at the 30th second and ends at the 90th second.

Baseline
Ultrasonography
Lasso di tempo: Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement

The ultrasonography is used to measure participants' thickness and cross-sectional area of Achilles tendon, flexor hallucis brevis, abductor hallucis, flexor digitorum brevis, and quadrate plantae in prone position and patella tendon in supine position.

Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Collaboratori

Investigatori

  • Investigatore principale: Hui-Ting Shih, PhD, Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
  • Direttore dello studio: Fu-Lien Wu, PhD, School and Graduate Institute of Physical Therapy, National Taiwan University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

24 ottobre 2026

Completamento primario (Stimato)

31 agosto 2027

Completamento dello studio (Stimato)

31 agosto 2027

Date di iscrizione allo studio

Primo inviato

27 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 novembre 2026

Primo Inserito (Effettivo)

10 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 novembre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • NYCU115200AE

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .