- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Chuan-Chih Chiang, MSc
- 전화번호: +886-2-2700-2880
- 이메일: meetsweetptc@gmail.com
연구 장소
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Taipei, 대만, 106064
- 모병
- 1F., No. 25, Ln. 112, Sec, Section 1, Anhe Rd, Da'an District
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연락하다:
- Chuan-Chih Chiang, MSc
- 전화번호: +886-2-2700-2880
- 이메일: meetsweetptc@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Participants are community runners and are recruited through flyers, posters, and social media platforms, such as, Facebook, Instagram or LINE.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_CONTROL
- 시간 관점: PROSPECTIVE
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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history of injuries
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
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공동 작업자 및 조사자
수사관
- 수석 연구원: Hui-Ting Shih, PhD, Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
- 연구 책임자: Fu-Lien Wu, PhD, School and Graduate Institute of Physical Therapy, National Taiwan University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- NYCU115200AE
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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