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Morphological and Functional Biomarkers of Skeletal Muscle Adaptations in Sarcopenia (EXEDOS)

2026年7月9日 更新者：I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Morphological and Functional Biomarkers of Skeletal Muscle Adaptations for Early Detection of Sarcopenia and of the Therapeutic Effects of a Home-Based Exercise Intervention: A Randomized-Controlled Trial

Sarcopenia is an age-related condition characterized by progressive loss of skeletal muscle mass, muscle strength, and physical performance. It is associated with frailty, falls, disability, reduced independence, lower quality of life, and increased healthcare burden. Despite its clinical relevance, sarcopenia remains underdiagnosed, partly because current diagnostic approaches may be difficult to implement broadly in clinical practice and may not fully capture early changes in muscle quality and neuromuscular function.

The EXEDOS study aims to evaluate an integrated diagnostic and therapeutic strategy for the early detection and management of sarcopenia. The study will assess Quantitative Ultrasound with Radio-Frequency analysis (QUS-RF) as a non-invasive, accessible, and radiation-free tool to characterize muscle morphology, microstructure, and quality. QUS-RF-derived parameters will be compared with established assessments, including body composition, muscle strength, physical performance, and imaging-based measures, to determine their feasibility, reliability, diagnostic accuracy, and responsiveness to change.

The study also includes a 48-week randomized, parallel-group, open-label superiority trial designed to evaluate the effects of a digitally delivered home-based exercise intervention in older adults with sarcopenia or at risk of sarcopenia. Eligible participants will be randomized to either an experimental group receiving a structured home-based exercise program or a control group receiving general physical activity recommendations in line with current guidelines. The exercise program will combine progressive resistance and aerobic training and will be supported by a digital platform allowing remote monitoring, feedback, and supervision. All participants will receive general nutritional advice.

Assessments will be performed at baseline, Week 12, and Week 48. The primary outcome of the randomized trial will be the change in 30-second Chair Stand Test performance, used as an indicator of lower-limb muscle function. Secondary outcomes will include handgrip strength, lower-limb maximal and explosive strength, walking capacity, balance, body composition, QUS-RF-derived muscle parameters, quality of life, mood, physical activity, dietary indicators, blood biomarkers, adherence to the intervention, and safety. A health economic analysis will also be conducted to estimate the potential cost-effectiveness and cost-utility of the proposed diagnostic and therapeutic strategy.

By combining innovative muscle assessment with a scalable digitally supported exercise intervention, the EXEDOS study aims to improve early sarcopenia detection, personalize exercise prescription, and support the development of sustainable strategies to preserve muscle function and independence in older adults.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

192

段階

  • 適用できない

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

研究場所

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

説明

Inclusion Criteria:

  • Sedentary individuals aged over 50 years.
  • Individuals with sarcopenia, defined as reduced muscle mass assessed by bioelectrical impedance analysis and reduced muscle strength assessed by handgrip strength, according to EWGSOP2 criteria.
  • Individuals at risk of sarcopenia, defined as reduced muscle mass with preserved muscle strength.
  • Healthy age-, sex-, and physical activity-matched older adults eligible for inclusion in the reference cohort.
  • Ability to understand the study procedures and provide written informed consent.

Exclusion Criteria:

  • Hospitalization within the previous 6 weeks.
  • Substance or alcohol abuse.
  • Use of medications that may impair balance or coordination.
  • Major locomotor impairments.
  • Inability to complete the exercise protocol.
  • Medical, cognitive, or functional conditions that, in the opinion of the investigators, may interfere with safe participation, adherence to the study procedures, or completion of the follow-up assessments.

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

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Sarcopenia - Exercise Intervention
Participants with sarcopenia allocated to the exercise group will receive a 48-week digitally delivered home-based exercise intervention. The program will include progressive resistance exercises using body weight and/or light external loads, combined with moderate-intensity aerobic training. Sessions will be performed three times per week for approximately 45 minutes per session. The intervention will be supported by a digital platform, wearable inertial sensors, heart-rate monitoring, instructional videos, automated feedback, and remote professional supervision. Participants will also receive general nutritional advice.
行動：Digitally delivered home-based exercise intervention
Digitally delivered, home-based, 48-week exercise program combining progressive resistance training and moderate-intensity aerobic training. Participants will perform three sessions per week, each lasting approximately 45 minutes. Resistance exercises will use body weight and/or light external loads and will follow progressive overload principles. Aerobic exercise intensity will be adjusted using heart-rate feedback. The intervention will be delivered through a certified digital therapeutic platform including instructional videos, wearable inertial sensors, heart-rate monitoring, automated feedback, and remote professional supervision through chat or video call. Training progression will be individualized using adherence data, functional assessments, and monitoring outputs.
アクティブコンパレータ：Sarcopenia - Control
Participants with sarcopenia allocated to the control group will receive general physical activity recommendations in line with current WHO guidelines and general nutritional advice. They will not receive the digitally delivered individualized exercise intervention. Participants will undergo the same assessment schedule as the intervention group, including baseline, Week 12, and Week 48 evaluations of muscle strength, physical performance, balance, body composition, QUS-RF-derived muscle parameters, questionnaires, dietary monitoring, and blood biomarkers, according to the study protocol.
行動：General physical activity recommendations
Participants allocated to the control condition will receive general physical activity recommendations in line with current WHO guidelines and general nutritional advice. They will not receive the digitally delivered individualized exercise program, wearable sensor-based monitoring, automated feedback, or remote exercise supervision. This intervention is intended to represent a standard recommendation-based comparator condition against which the digitally delivered home-based exercise intervention will be evaluated.
実験的：Pre-sarcopenia - Exercise Intervention
Participants at risk of sarcopenia, defined by reduced muscle mass with preserved muscle strength, allocated to the exercise group will receive a 48-week digitally delivered home-based exercise intervention. The program will combine progressive resistance training using body weight and/or light external loads with moderate-intensity aerobic training. Sessions will be performed three times per week for approximately 45 minutes per session. Training will be monitored through a digital platform including wearable inertial sensors, heart-rate monitoring, instructional videos, automated feedback, and remote professional supervision. Participants will also receive general nutritional advice.
行動：Digitally delivered home-based exercise intervention
Digitally delivered, home-based, 48-week exercise program combining progressive resistance training and moderate-intensity aerobic training. Participants will perform three sessions per week, each lasting approximately 45 minutes. Resistance exercises will use body weight and/or light external loads and will follow progressive overload principles. Aerobic exercise intensity will be adjusted using heart-rate feedback. The intervention will be delivered through a certified digital therapeutic platform including instructional videos, wearable inertial sensors, heart-rate monitoring, automated feedback, and remote professional supervision through chat or video call. Training progression will be individualized using adherence data, functional assessments, and monitoring outputs.
アクティブコンパレータ：Pre-sarcopenia - Control
Participants at risk of sarcopenia, defined by reduced muscle mass with preserved muscle strength, allocated to the control group will receive general physical activity recommendations in line with current WHO guidelines and general nutritional advice. They will not receive the digitally delivered individualized exercise intervention. Participants will complete the same assessment schedule as the intervention group, including baseline, Week 12, and Week 48 evaluations of muscle strength, physical performance, balance, body composition, QUS-RF-derived muscle parameters, questionnaires, dietary monitoring, and blood biomarkers.
行動：General physical activity recommendations
Participants allocated to the control condition will receive general physical activity recommendations in line with current WHO guidelines and general nutritional advice. They will not receive the digitally delivered individualized exercise program, wearable sensor-based monitoring, automated feedback, or remote exercise supervision. This intervention is intended to represent a standard recommendation-based comparator condition against which the digitally delivered home-based exercise intervention will be evaluated.
介入なし：Healthy Reference Cohort
Healthy age-, sex-, and physical activity-matched older adults will be included as a non-randomized reference cohort. These participants will not receive the digitally delivered exercise intervention and will not be assigned to the control condition. They will undergo the scheduled study assessments to provide reference values for diagnostic and longitudinal comparisons, including evaluations of body composition, QUS-RF-derived muscle parameters, muscle strength, physical performance, balance, questionnaires, dietary monitoring, and blood biomarkers at the planned study time points.

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
Change in 30-second Chair Stand Test performance
時間枠：Baseline, Week 12, and Week 48
Lower-limb muscle function will be assessed using the 30-second Chair Stand Test. Participants will be asked to complete as many sit-to-stand repetitions as possible within 30 seconds using a standardized protocol. The outcome will be expressed as the number of complete repetitions. The primary analysis will evaluate changes from baseline to Week 12 and Week 48 between the exercise intervention and control groups.
Baseline, Week 12, and Week 48

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in handgrip strength
時間枠：Baseline, Week 12, and Week 48
Maximal handgrip strength will be assessed using a handgrip dynamometer according to a standardized protocol. The outcome will be expressed in kilograms or Newtons, according to the device output. Changes from baseline to Week 12 and Week 48 will be compared between groups.
Baseline, Week 12, and Week 48
Change in lower-limb explosive strength
時間枠：Baseline, Week 12, and Week 48
Explosive strength and rapid force production will be assessed during lower-limb contractions using standardized dynamometric procedures. The outcome will quantify the ability to rapidly generate force and will be used to characterize neuromuscular adaptations to the intervention.
Baseline, Week 12, and Week 48
Change in 6-Minute Walk Test distance
時間枠：Baseline, Week 12, and Week 48
Functional walking capacity will be assessed using the 6-Minute Walk Test. Participants will be instructed to walk as far as possible in 6 minutes according to a standardized protocol. The outcome will be expressed as distance walked in meters.
Baseline, Week 12, and Week 48
Change in Mini-Balance Evaluation Systems Test score
時間枠：Baseline, Week 12, and Week 48
Balance performance will be assessed using the Mini-Balance Evaluation Systems Test. The total score ranges from 0 to 28 points, with higher scores indicating better balance performance. Changes from baseline to Week 12 and Week 48 will be evaluated to assess intervention-related effects on balance.
Baseline, Week 12, and Week 48
Change in fat mass assessed by bioelectrical impedance analysis
時間枠：Fat mass will be assessed using bioelectrical impedance analysis according to standardized procedures. The outcome will be expressed in percentage. Changes from baseline to Week 12 and Week 48 will be evaluated.
Baseline, Week 12, and Week 48
Fat mass will be assessed using bioelectrical impedance analysis according to standardized procedures. The outcome will be expressed in percentage. Changes from baseline to Week 12 and Week 48 will be evaluated.
Change in lean mass assessed by bioelectrical impedance analysis
時間枠：Baseline, Week 12, and Week 48
Lean mass will be assessed using bioelectrical impedance analysis according to standardized procedures. The outcome will be expressed in percentage. Changes from baseline to Week 12 and Week 48 will be evaluated.
Baseline, Week 12, and Week 48
Change in skeletal muscle mass index assessed by bioelectrical impedance analysis
時間枠：Baseline, Week 12, and Week 48
Skeletal muscle mass index will be assessed using bioelectrical impedance analysis according to standardized procedures. The outcome will be expressed as kilograms per square meter. Changes from baseline to Week 12 and Week 48 will be evaluated.
Baseline, Week 12, and Week 48
Change in quantitative ultrasound radio-frequency-derived muscle echo-intensity parameters
時間枠：Baseline, Week 12, and Week 48
Quantitative ultrasound radio-frequency analysis will be used to assess muscle quality and microstructure. The primary QUS-RF parameter will be muscle echo-intensity, derived from standardized ultrasound acquisitions of selected lower-limb muscles. The outcome will be expressed in arbitrary units or grayscale units, according to the image analysis output. Changes from baseline to Week 12 and Week 48 will be evaluated and related to functional outcomes.
Baseline, Week 12, and Week 48
Area under the receiver operating characteristic curve of quantitative ultrasound radio-frequency analysis for sarcopenia classification
時間枠：Baseline
The diagnostic performance of quantitative ultrasound radio-frequency-derived muscle parameters for classifying sarcopenia status will be evaluated against reference criteria based on muscle mass and muscle strength. Diagnostic accuracy will be expressed as the area under the receiver operating characteristic curve. The area under the receiver operating characteristic curve ranges from 0.5 to 1.0 for a clinically useful classifier, with higher values indicating better diagnostic accuracy.
Baseline
Change in 12-Item Short Form Health Survey Physical Component Summary score
時間枠：Baseline, Week 12, and Week 48
Health-related physical quality of life will be assessed using the 12-Item Short Form Health Survey Physical Component Summary score. The score ranges from 0 to 100, with higher scores indicating better physical health-related quality of life. Changes from baseline to Week 12 and Week 48 will be evaluated between groups.
Baseline, Week 12, and Week 48
Change in 12-Item Short Form Health Survey Mental Component Summary score
時間枠：Baseline, Week 12, and Week 48
Health-related mental quality of life will be assessed using the 12-Item Short Form Health Survey Mental Component Summary score. The score ranges from 0 to 100, with higher scores indicating better mental health-related quality of life. Changes from baseline to Week 12 and Week 48 will be evaluated between groups.
Baseline, Week 12, and Week 48
Change in appendicular skeletal muscle mass index assessed by dual-energy X-ray absorptiometry
時間枠：Baseline and Week 48
Appendicular skeletal muscle mass index will be assessed using dual-energy X-ray absorptiometry. The index will be calculated as appendicular skeletal muscle mass divided by height squared and expressed in kilograms per square meter. This is a continuous body composition parameter, not a scale score; therefore, no fixed minimum or maximum values apply. Higher values indicate greater appendicular skeletal muscle mass relative to height.
Baseline and Week 48
Change in Profile of Mood States Total Mood Disturbance score
時間枠：Baseline, Week 12, and Week 48
Mood state will be assessed using the Profile of Mood States questionnaire. The Total Mood Disturbance score will be calculated according to standard scoring procedures. Higher scores indicate greater mood disturbance and therefore a worse mood-related outcome. Changes from baseline to Week 12 and Week 48 will be evaluated between groups.
Baseline, Week 12, and Week 48
Change in C-reactive protein concentration
時間枠：Baseline and Week 48
Systemic inflammation will be assessed by measuring serum C-reactive protein concentration. The outcome will be expressed in milligrams per liter. Changes from baseline to Week 48 will be evaluated between groups.
Baseline and Week 48

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

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

協力者

Universita di Verona

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 (実際)

2026年6月3日

一次修了 (推定)

2027年6月3日

研究の完了 (推定)

2029年6月3日

試験登録日

最初に提出

2026年6月26日

QC基準を満たした最初の提出物

2026年7月2日

最初の投稿 (実際)

2026年7月9日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月13日

QC基準を満たした最後の更新が送信されました

2026年7月9日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • GR-2024-12378411

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いいえ

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