- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07929311
Developing a Biopsychosocial Prediction Model for Running-Related Injuries
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Chuan-Chih Chiang, MSc
- Numéro de téléphone: +886-2-2700-2880
- E-mail: meetsweetptc@gmail.com
Lieux d'étude
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Taipei, Taïwan, 106064
- Recrutement
- 1F., No. 25, Ln. 112, Sec, Section 1, Anhe Rd, Da'an District
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Contact:
- Chuan-Chih Chiang, MSc
- Numéro de téléphone: +886-2-2700-2880
- E-mail: meetsweetptc@gmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Participants are community runners and are recruited through flyers, posters, and social media platforms, such as, Facebook, Instagram or LINE.
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: CASE_CONTROL
- Perspectives temporelles: PROSPECTIVE
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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history of injuries
Délai: Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement
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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
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running habits
Délai: Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement
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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
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Level of Physical Activity
Délai: Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement
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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
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Passion
Délai: Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement
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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
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Endurance Sports Self-Efficacy
Délai: Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement
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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
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Grit
Délai: Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement
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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
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Sleep Quality
Délai: Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement
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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
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Chronotype
Délai: Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement
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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
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Muscle Strength
Délai: Baseline
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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
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Navicular Drop
Délai: Baseline
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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
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Running Kinematics
Délai: Baseline
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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
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Ultrasonography
Délai: Baseline, 1-, 2-, 3-, 4-, 5-, and 6-month post-baseline measurement
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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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Hui-Ting Shih, PhD, Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
- Directeur d'études: Fu-Lien Wu, PhD, School and Graduate Institute of Physical Therapy, National Taiwan University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- NYCU115200AE
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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