- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07754162
Inter-Rater Reliability of Ultra Sound Based Rectus Abdominis Thickness Following Blood Flow Restriction Training
Inter-Rater Reliability of Ultra Sound Based Rectus Abdominis Thickness Following Blood Flow Restriction Training : A Retrospective Analysis.
Обзор исследования
Статус
Условия
Подробное описание
A retrospective methodological reliability study design will be employed to evaluate the inter-rater reliability of ultrasound-based measurements of rectus abdominis muscle thickness following a standardized blood flow restriction (BFR) training protocol. The study will utilize previously collected B-mode ultrasound images obtained from healthy young adult male participants who completed the original BFR training protocol. The existing dataset will be reviewed according to predefined eligibility criteria, and only ultrasound images of sufficient quality for identification and measurement of the rectus abdominis muscle will be included in the analysis.
The original BFR training protocol involved low-load resistance exercise performed under blood flow restriction. During the intervention, pneumatic cuffs were applied to the limbs, and participants performed a standardized squat exercise protocol at a low percentage of one-repetition maximum with prescribed repetitions and rest intervals. Ultrasound images of the rectus abdominis obtained according to the standardized imaging protocol will be analyzed retrospectively. The rectus abdominis was selected because it is a superficial abdominal muscle that can be visualized using B-mode ultrasonography and has relatively well-defined anatomical boundaries, allowing its thickness to be assessed using a standardized measurement procedure. Furthermore, the rectus abdominis contributes to trunk stabilization during functional and resistance exercises.
Ultrasound images will be analyzed using ImageJ software. Two independent raters will perform the measurements of rectus abdominis muscle thickness using the same standardized measurement protocol. The raters will independently identify the anatomical boundaries of the rectus abdominis and obtain linear thickness measurements from the ultrasound images. The use of a single standardized image-analysis platform and identical measurement procedures for both raters will minimize variability related to software and measurement techniques. The primary outcome will be the rectus abdominis muscle thickness measured in millimeters (mm).
Inter-rater reliability will be assessed using the Intraclass Correlation Coefficient (ICC) with a two-way random-effects model for absolute agreement and single measurements [ICC (2,1)], reported with the corresponding 95% confidence interval. ICC values below 0.50 will be interpreted as poor reliability, values from 0.50 to 0.75 as moderate reliability, values from 0.75 to 0.90 as good reliability, and values above 0.90 as excellent reliability. Absolute reliability and measurement error will additionally be assessed using the Standard Error of Measurement (SEM) and Minimal Detectable Change at the 95% confidence level (MDC95), where appropriate. Bland-Altman analysis will be performed to evaluate systematic differences and limits of agreement between the two raters. All statistical analyses will be conducted using SPSS, with the level of statistical significance set at p < 0.05.
If the ultrasound-based rectus abdominis thickness measurement demonstrates good to excellent inter-rater reliability, the findings will support the reproducibility of the standardized measurement protocol and its application in future research involving abdominal muscle morphology. The study may provide a methodological foundation for future investigations examining changes in abdominal muscle morphology following BFR and other exercise interventions, with potential relevance to sports physiotherapy, rehabilitation, and exercise science.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Muhammad Haris, DPT
- Номер телефона: 03437181808
- Электронная почта: harismughal5154@gmail.com
Учебное резервное копирование контактов
- Имя: Dr Saad Rauf, PhD
- Номер телефона: 03325957732
Места учебы
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Islamabad, Пакистан, 44000
- Рекрутинг
- Faculty of Rehabilitation for Data Collection and Research Work
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Контакт:
- Muhammad Haris
- Номер телефона: 03437181808
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Recreationally Active
Exclusion Criteria:
- Known Musculoskeletal injury
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
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Retrospective BFR Cohort
Healthy active male participants who underwent a short-duration blood flow restriction (BFR) training protocol.
Pre- and post-training ultrasound images of the rectus abdominis muscle were retrospectively analyzed to assess inter-rater reliability of ultrasound-based muscle thickness measurements.
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Group 1
Healthy active male participants assessed before the BFR training program.
Baseline B-mode ultrasound images of the rectus abdominis muscle were obtained and used for measurement of muscle thickness.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Inter-rater reliability of ultrasound-based rectus abdominis muscle thickness measurement
Временное ограничение: Baseline (pre-training) and post-training ultrasound images obtained at the completion of the two-week BFR training protocol.
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Inter-rater reliability between two independent raters in measuring rectus abdominis muscle thickness from B-mode ultrasound images using ImageJ software.
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Baseline (pre-training) and post-training ultrasound images obtained at the completion of the two-week BFR training protocol.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Inter-rater reliability of ultrasound-based rectus abdominis muscle thickness measurement
Временное ограничение: Pre-training and immediately post-training.
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Rectus abdominis muscle thickness
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Pre-training and immediately post-training.
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Saad Rauf, PhD, Riphah International University, Isra University, Islamabad
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- REC/MS-PT/02569
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .