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Ultrasound Muscle Biomarkers as Predictors of Isometric Quadriceps Muscle Strength and Handgrip in Healthy Adults: an Observational Study (MUSCLE-US)

2026年6月12日 更新者：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.

調査の概要

状態

まだ募集していません

条件

詳細な説明

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.

研究の種類

観察的

入学 (推定)

300

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

  • 名前：Beatriz Sánchez-Sánchez, PT, Ph.D.
  • 電話番号：+34 918 85 48 28
  • メール：beatriz.sanchez@uah.es

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Isometric quadriceps muscle strength
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Five-repetition sit-to-stand test
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Age
時間枠：Day 1
Participant age recorded in completed years.
Day 1
Weight
時間枠：Day 1
Participant weight recorded in kilograms.
Day 1
Height
時間枠：Day 1
Participant height recorded in metres.
Day 1
Body mass index
時間枠：Day 1
Body mass index calculated as weight divided by height squared.
Day 1
Sex
時間枠：Day 1
Participant biological sex recorded as female or male.
Day 1
Systemic inflammation markers
時間枠：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
時間枠：Day 1
Comorbidity burden assessed using the Charlson Comorbidity Index. Higher scores indicate greater comorbidity burden.
Day 1
Anatomical Therapeutic Chemical (ATC) Classification System
時間枠：Day 1
Current medication use classified according to the Anatomical Therapeutic Chemical (ATC) Classification System.
Day 1
Alcohol Use Disorders Identification Test-Consumption
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Alcala

捜査官

  • 主任研究者：Nicola S. Diciolla, PT, Ph.D.、University of Alcala

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2028年6月1日

研究の完了 (推定)

2029年6月1日

試験登録日

最初に提出

2026年6月9日

QC基準を満たした最初の提出物

2026年6月9日

最初の投稿 (実際)

2026年6月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月16日

QC基準を満たした最後の更新が送信されました

2026年6月12日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • CEIP/2026/2/39

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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.

IPD 共有時間枠

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.

IPD 共有アクセス基準

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.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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