Ultrasound Muscle Biomarkers as Predictors of Isometric Quadriceps Muscle Strength and Handgrip in Healthy Adults: an Observational Study (MUSCLE-US)
12 июня 2026 г. обновлено: Nicola S. Diciolla, University of Alcala
This observational study aims to determine whether ultrasound-derived muscle biomarkers can predict isometric quadriceps muscle strength and handgrip in healthy adults aged 18-89 years.
The main questions it aims to answer are:
- Which ultrasound muscle characteristics are associated with isometric quadriceps muscle strength and handgrip?
- Can ultrasound-derived biomarkers be used to develop predictive models of muscle strength in healthy adults?
Participants will undergo:
- Ultrasound assessment of the quadriceps and forearm flexor muscles;
- Measurement of isometric quadriceps muscle strength and handgrip using standardized dynamometry protocols;
- Assessment of functional capacity, mobility and balance;
- Completion of questionnaires related to health status, physical activity, nutrition, fatigue and health-related quality of life.
The study will also assess the reliability of ultrasound measurements and explore the relationship between ultrasound variables, muscle strength, physical function and health-related factors.
Обзор исследования
Статус
Еще не набирают
Подробное описание
Peripheral muscle strength is an important determinant of physical function, independence and health outcomes. Reduced quadriceps muscle strength and handgrip have been associated with functional limitations, frailty, hospitalization and mortality. Although muscle ultrasound is increasingly used to assess muscle morphology and quality, its ability to predict muscle strength remains incompletely understood.
The MUSCLE-US study is a monocentre observational study designed to investigate the relationship between ultrasound-derived muscle biomarkers and isometric quadriceps muscle strength and handgrip in healthy adults. Participants aged 18-89 years will be recruited from community settings and stratified by age and sex.
Ultrasound assessments will be performed on the quadriceps and forearm flexor muscles using standardized acquisition procedures. First-order variables (e.g., muscle thickness, cross-sectional area, pennation angle, fascicle length), second-order texture features and higher-order ultrasound biomarkers will be extracted and analysed.
Isometric quadriceps muscle strength and handgrip will be measured using standardized dynamometry protocols. Additional assessments will include functional capacity tests, mobility and balance measures, physical activity, nutritional status, fatigue, dyspnoea, health-related quality of life, lifestyle factors and comorbidity profiles.
The primary objective is to identify ultrasound biomarkers associated with quadriceps muscle strength and handgrip, and to develop predictive models of muscle strength. Secondary objectives include assessment of ultrasound measurement reliability and exploration of relationships between ultrasound biomarkers, muscle strength, physical function and health-related characteristics.
Recruitment, assessor training, ultrasound standardisation procedures and reliability analyses will be conducted during the initial phase of the project, followed by the main recruitment and data collection phase and subsequent statistical modelling and dissemination activities.
Тип исследования
Наблюдательный
Регистрация (Оцененный)
300
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Nicola S. Diciolla, PT, Ph.D.
- Номер телефона: +34 918 85 48 28
- Электронная почта: nicola.diciolla@uah.es
Учебное резервное копирование контактов
- Имя: Beatriz Sánchez-Sánchez, PT, Ph.D.
- Номер телефона: +34 918 85 48 28
- Электронная почта: beatriz.sanchez@uah.es
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Да
Метод выборки
Невероятностная выборка
Исследуемая популяция
Community-dwelling healthy adults aged 18-89 years residing in Spain.
Participants will be recruited through community advertisements, institutional dissemination channels, and collaborating centres.
The study aims to investigate the relationship between ultrasound-derived muscle biomarkers and isometric quadriceps muscle strength and handgrip in a healthy adult population.
Описание
Inclusion Criteria:
- Healthy adults aged 18-89 years.
- Resident in Spain for at least 5 years.
- Living independently in the community and able to complete all study assessments.
- Able to understand and follow verbal instructions in Spanish.
- Able and willing to provide written informed consent prior to study participation.
Exclusion Criteria:
- Neurological, musculoskeletal, or systemic disorders affecting muscle strength or mobility.
- Recent surgery or acute injury affecting the upper or lower limbs.
- Recent use of medications affecting the musculoskeletal system (e.g., systemic corticosteroids for >1 week during the previous 6 months or muscle relaxants during the previous week).
- Cognitive or psychiatric conditions limiting participation.
- Pregnancy.
- Recent postpartum period (≤3 months after delivery).
- Presence of clinically relevant pain, fatigue, physical deconditioning, or functional limitations that may interfere with study procedures or measurement validity.
- Acute illness at the time of assessment.
- Uncontrolled hypertension (≥140/90 mmHg).
- Resting peripheral oxygen saturation ≤90%.
- Moderate-to-severe pain (Numeric Rating Scale ≥4/10).
- Any medical condition considered by the investigator to contraindicate study participation.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
|---|
|
Healthy adults
Healthy/community-dwelling adults aged 18-89 years participating in an observational study evaluating ultrasound-derived muscle biomarkers and their relationship with isometric quadriceps muscle strength and handgrip.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Isometric quadriceps muscle strength
Временное ограничение: Day 1
|
Quadricpes maximal voluntary contraction measured using a handheld dynamometer according to a standardized testing protocol.
Peak force will be recorded in kilograms-force (kgf).
|
Day 1
|
|
Handgrip
Временное ограничение: Day 1
|
Maximal voluntary handgrip measured using a hydraulic hand dynamometer according to the American Society of Hand Therapists protocol.
Peak force will be recorded in kilograms-force (kgf).
|
Day 1
|
|
Ultrasound-derived muscle biomarkers
Временное ограничение: Day 1
|
Muscle ultrasound biomarkers obtained from standardized B-mode ultrasound images of selected quadriceps and forearm muscles.
Candidate variables include muscle morphology, architecture, grayscale characteristics and texture-based parameters.
The final set of ultrasound-derived biomarkers will be defined following assessor training, protocol standardization and pilot reliability analyses.
|
Day 1
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Five-repetition sit-to-stand test
Временное ограничение: Day 1
|
Functional capacity assessed by the time required to complete five sit-to-stand repetitions according to standardised procedures.
Results will be expressed in seconds.
Lower values indicate better lower-limb functional capacity.
|
Day 1
|
|
One-minute sit-to-stand test
Временное ограничение: Day 1
|
Functional capacity assessed as the number of sit-to-stand repetitions completed in one minute according to standardised procedures.
Higher values indicate better functional exercise capacity.
|
Day 1
|
|
Timed Up and Go test
Временное ограничение: Day 1
|
Mobility and dynamic balance assessed using the Timed Up and Go test.
Results will be expressed in seconds.
Lower values indicate better mobility and dynamic balance.
|
Day 1
|
|
Modified Medical Research Council dyspnoea scale
Временное ограничение: Day 1
|
Dyspnoea severity assessed using the modified Medical Research Council dyspnoea scale.
Scores range from 0 to 4, with higher scores indicating greater breathlessness.
|
Day 1
|
|
Modified Borg dyspnoea scale
Временное ограничение: Day 1
|
Perceived breathlessness assessed using the modified Borg dyspnoea scale.
Scores range from 0 to 10, with higher scores indicating greater breathlessness.
|
Day 1
|
|
Dyspnoea-12
Временное ограничение: Day 1
|
Dyspnoea assessed using the Dyspnoea-12 questionnaire.
The total score ranges from 0 to 36, with higher scores indicating more severe breathlessness.
|
Day 1
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue
Временное ограничение: Day 1
|
Fatigue assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire.
Scores range from 0 to 52, with higher scores indicating less fatigue.
|
Day 1
|
|
EuroQol 5-Dimension 5-Level
Временное ограничение: Day 1
|
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D) questionnaire.
The index score will be calculated according to the appropriate national value set.
Higher scores indicate better health status.
Self-rated health assessed using the EQ-5D Visual Analogue Scale.
Scores range from 0 to 100, with higher scores indicating better perceived health.
|
Day 1
|
|
International Physical Activity Questionnaire-short form
Временное ограничение: Day 1
|
Physical activity assessed using the International Physical Activity Questionnaire-short form.
Results will be expressed as minutes per week spent in vigorous/moderate/total physical activity, time per week spent walking and hours per day spent in sedentary behaviour (sitting).
|
Day 1
|
|
Mini Nutritional Assessment-short form
Временное ограничение: Day 1
|
Nutritional status assessed using the Mini Nutritional Assessment-short form.
Scores range from 0 to 14, with higher scores indicating better nutritional status.
|
Day 1
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Age
Временное ограничение: Day 1
|
Participant age recorded in completed years.
|
Day 1
|
|
Weight
Временное ограничение: Day 1
|
Participant weight recorded in kilograms.
|
Day 1
|
|
Height
Временное ограничение: Day 1
|
Participant height recorded in metres.
|
Day 1
|
|
Body mass index
Временное ограничение: Day 1
|
Body mass index calculated as weight divided by height squared.
|
Day 1
|
|
Sex
Временное ограничение: Day 1
|
Participant biological sex recorded as female or male.
|
Day 1
|
|
Systemic inflammation markers
Временное ограничение: Day 1
|
CRP, IL-6, eosinophils, fibrinogen, neutrophil elastase, ESR, KL-6, SP-D, FeNO, IgE, calprotectin, if available, from medical records.
|
Day 1
|
|
Charlson Comorbidity Index
Временное ограничение: Day 1
|
Comorbidity burden assessed using the Charlson Comorbidity Index.
Higher scores indicate greater comorbidity burden.
|
Day 1
|
|
Anatomical Therapeutic Chemical (ATC) Classification System
Временное ограничение: Day 1
|
Current medication use classified according to the Anatomical Therapeutic Chemical (ATC) Classification System.
|
Day 1
|
|
Alcohol Use Disorders Identification Test-Consumption
Временное ограничение: Day 1
|
Alcohol consumption assessed using the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C).
Higher scores indicate greater alcohol consumption and increased risk of hazardous drinking.
|
Day 1
|
|
Smoking Exposure (pack-year index)
Временное ограничение: Day 1
|
Lifetime smoking exposure quantified using the pack-year index, calculated from self-reported smoking history.
A higher pack-year index means greater cumulative exposure to tobacco smoking over lifetime.
|
Day 1
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Nicola S. Diciolla, PT, Ph.D., University of Alcala
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 июня 2026 г.
Первичное завершение (Оцененный)
1 июня 2028 г.
Завершение исследования (Оцененный)
1 июня 2029 г.
Даты регистрации исследования
Первый отправленный
9 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
9 июня 2026 г.
Первый опубликованный (Действительный)
15 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
16 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
12 июня 2026 г.
Последняя проверка
1 июня 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- CEIP/2026/2/39
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
Individual participant data (IPD) that underlie the results reported in publications, after de-identification, will be made available.
Shared data may include demographic characteristics, anthropometric variables, isometric quadriceps muscle strength, handgrip, ultrasound-derived muscle variables, functional capacity measures, and patient-reported outcomes/questionnaire data collected as part of the study.
Direct identifiers will be removed before data sharing.
Data sharing will comply with applicable ethical approvals, informed consent provisions, and data protection regulations.
Сроки обмена IPD
De-identified individual participant data and supporting documents will become available beginning 12 months after publication of the primary study results and will remain available for at least 5 years thereafter.
Критерии совместного доступа к IPD
Researchers who provide a methodologically sound proposal for secondary analyses or validation studies may request access to the de-identified dataset.
Requests will be reviewed by the study investigators.
Data will be provided following approval of the proposal and execution of a data-sharing agreement, when required, in accordance with ethical and legal requirements.
Supporting documents, including the study protocol, statistical analysis plan, informed consent form template, and analytic code, will be made available upon reasonable request.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
- АНАЛИТИЧЕСКИЙ_КОД
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
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. .