ClinicalTrials.gg
RecruitingNCT07929311Updated Nov 10, 2026

Developing a Biopsychosocial Prediction Model for Running-Related Injuries

An observational study in Running-related Injuries, sponsored by National Yang Ming Chiao Tung University. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by National Yang Ming Chiao Tung University · Observational

Updated Nov 10, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Running-related Injuries

Keywords

  • ultrasonography
  • Handheld Dynamometer
  • Passion Scale
  • GRIT scale
  • Endurance Sport Self-Efficacy Scale
  • The Pittsburgh Sleep Quality Index
  • Horne and Ostberg Morningness-Eveningness Questionnaire
  • motion analysis
03

In context

Lead sponsor

National Yang Ming Chiao Tung University is the lead sponsor of 208 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 for middle and high intensity activities; (4) have disorders; (5) have cancer; (6) are in fever or acute inflammation; or (7) are in pregnancy.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Biologicalrunning activities

    Running activities include running training and marathon participation.

06

What researchers measure

Primary outcomes

  1. history of injuries

    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.

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

  2. running habits

    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.

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

  3. Level of Physical Activity

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

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

  4. Passion

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

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

  5. Endurance Sports Self-Efficacy

    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'.

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

  6. Grit

    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'.

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

  7. Sleep Quality

    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.

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

  8. Chronotype

    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.

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

  9. Muscle Strength

    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.

    Time frame: Baseline

  10. Navicular Drop

    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.

    Time frame: Baseline

  11. Running Kinematics

    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.

    Time frame: Baseline

  12. Ultrasonography

    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.

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

07

Study locations

1 of 1 sites recruiting
  • 1F., No. 25, Ln. 112, Sec, Section 1, Anhe Rd, Da'an District
    Taipei, 106064, Taiwan
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Aug 2027, 10 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2026
First posted
Nov 10, 2026
StartEst.
Oct 24, 2026
Primary completionEst.
Aug 31, 2027
CompletionEst.
Aug 31, 2027
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07929311
Collaborators
Meetsweet Physical Therapy Clinic, National Taiwan University
Responsible party
Hui-Ting Shih (Assistant Professor, National Yang Ming Chiao Tung University) — Principal investigator
First posted
Nov 10, 2026
Start date
Oct 24, 2026 (estimated)
Primary completion
Aug 31, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Nov 10, 2026

Study contacts

Chuan-Chih Chiang, MSc
Contact
meetsweetptc@gmail.com
+886-2-2700-2880
Hui-Ting Shih, PhD
principal investigator · Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
Fu-Lien Wu, PhD
study director · School and Graduate Institute of Physical Therapy, National Taiwan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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