Developing a Biopsychosocial Prediction Model for Running-Related Injuries
Running-related Injuries
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 18 years - 80 years
- Sex eligible
- All sexes
- Healthy volunteers
- Accepted
- Participants
- 100 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Study population
Participants are community runners and are recruited through flyers, posters, and social media platforms, such as, Facebook, Instagram or LINE.
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
running activities BIOLOGICAL
Running activities include running training and marathon participation.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
history of injuries
Time frame: 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.
running habits
Time frame: 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.
Level of Physical Activity
Time frame: 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.
Passion
Time frame: 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.
Endurance Sports Self-Efficacy
Time frame: 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'.
Grit
Time frame: 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'.
Sleep Quality
Time frame: 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.
Chronotype
Time frame: 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.
Muscle Strength
Time frame: 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.
Navicular Drop
Time frame: 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.
Running Kinematics
Time frame: 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.
Ultrasonography
Time frame: 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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
1F., No. 25, Ln. 112, Sec, Section 1, Anhe Rd, Da'an DistrictTaipei, TaiwanRecruiting
Study team and timeline
- Lead sponsor
- National Yang Ming Chiao Tung University
- Study start
- Oct 24, 2026 Estimated
- Primary completion
- Aug 31, 2027 Estimated
- Study completion
- Aug 31, 2027 Estimated
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Developing a Biopsychosocial Prediction Model for Running-Related Injuries
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026