Ultrasound Muscle Biomarkers as Predictors of Isometric Quadriceps Muscle Strength and Handgrip in Healthy Adults: an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Isometric quadriceps muscle strength
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Isometric quadriceps muscle strength
时间窗: 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).
Handgrip
时间窗: 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).
Ultrasound-derived muscle biomarkers
时间窗: 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.
次要结局
- Five-repetition sit-to-stand test(Day 1)
- One-minute sit-to-stand test(Day 1)
- Timed Up and Go test(Day 1)
- Modified Medical Research Council dyspnoea scale(Day 1)
- Modified Borg dyspnoea scale(Day 1)
- Dyspnoea-12(Day 1)
- Functional Assessment of Chronic Illness Therapy-Fatigue(Day 1)
- EuroQol 5-Dimension 5-Level(Day 1)
- International Physical Activity Questionnaire-short form(Day 1)
- Mini Nutritional Assessment-short form(Day 1)
研究者
Nicola S. Diciolla
Principal Investigator, Scientific Coordinator
University of Alcala