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Évaluation de la sécurité et de l'efficacité d'un dispositif thérapeutique numérique pour améliorer la force dans la sarcopénie (Sarc-DTx)

28 septembre 2026 mis à jour par: Exosystems

Essai clinique confirmatoire multicentrique, prospectif, randomisé, en groupes parallèles, en simple aveugle de l’évaluateur, visant à évaluer l’innocuité et l’efficacité d’un dispositif thérapeutique numérique pour améliorer la force musculaire chez les patients atteints de sarcopénie

This clinical trial aims to demonstrate that the use of a digital therapeutic device (exoDTx) in patients with sarcopenia is superior to self-exercise in terms of muscle strength improvement and safety.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

Background Sarcopenia is a condition characterized by progressive loss of skeletal muscle mass and strength, which is closely associated with functional decline, falls, and increased mortality.Conventional first-line treatment involves resistance training; however, in older adults, low adherence and practical challenges often limit its effectiveness.Recently, digital therapeutics (DTx) have emerged as promising tools by providing personalized exercise programs, automatic adjustment of intensity, and integrated recording and monitoring functions. These features are expected to overcome the limitations of selfdirected exercise.Therefore, this study seeks to validate the effectiveness and safety of DTx in improving muscle strength and physical function through a randomized controlled trial (RCT). Research Hypothesis In patients with sarcopenia, the group using digital therapeutics (DTx) will demonstrate superior outcomes in muscle strength improvement and safety compared to the self-exercise group.

Type d'étude

Interventionnel

Inscription (Estimé)

130

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Corée du Sud
      • Bucheon-si, Corée du Sud
        • Bucheon St. Mary's Hospital
      • Suwon, Corée du Sud
        • St.Vincent's hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

50 ans à 85 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria

  • Individuals diagnosed with sarcopenia according to both the European Working Group on Sarcopenia in Older People (EWGSOP) criteria and the Asian Working Group for Sarcopenia 2019 (AWGS 2019) criteria
  • Individuals with reduced muscle strength, defined as at least one of the following:
  • Handgrip strength < 28 kg for men or < 18 kg for women
  • Five-times Sit-to-Stand Test time > 12 seconds without arm support
  • Individuals with reduced muscle mass, defined as at least one of the following:
  • Skeletal Muscle Mass Index (SMI) < 7.0 kg/m² for men or < 5.4 kg/m² for women measured by DXA
  • Skeletal Muscle Mass Index (SMI) < 7.0 kg/m² for men or < 5.7 kg/m² for women measured by BIA
  • Individuals able to independently perform sit-to-stand movements
  • Individuals with sufficient physical and cognitive capacity to participate in the exercise program
  • Individuals able and willing to provide written informed consent
  • Individuals able to operate a mobile phone independently or with assistance from a caregiver

Exclusion Criteria

  • Individuals with cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score < 20, or those unable to participate due to cognitive decline
  • Individuals with an implanted cardiac pacemaker or other implanted electronic medical device
  • Individuals with uncontrolled cardiovascular disease despite appropriate medical management
  • Individuals who have undergone lower-limb surgery within the past 6 months and are unable to ambulate independently
  • Individuals with moderate-to-severe musculoskeletal pain or functional limitations that interfere with objective functional assessments
  • Individuals with severe obesity, defined as a body mass index (BMI) > 50 kg/m²
  • Individuals currently receiving active cancer treatment or experiencing severe systemic frailty
  • Individuals with hemiplegia that prevents participation in the prescribed exercise program
  • Individuals who are anticipated by the investigator to be unable to complete the study procedures or follow-up assessments
  • Individuals unable to understand or comply with study instructions provided in Korean
  • Individuals considered unsuitable for study participation at the discretion of the investigator for any other reason

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Experimental Device Group (Home-based DTx exercise group after training)

Participants perform personalized resistance exercises using a digital therapeutic device (mobile application) at home for 12 weeks, with sessions conducted at least 3 times per week, 50 minutes per session (≥150 minutes/week). The program includes exercise automatic intensity adjustment, exercise recording/analysis, and physician monitoring
Dispositif: exoDTx

Experimental group (exoDTx): After baseline on-site training, participants perform personalized resistance exercises at home using a mobile app ≥3 times/week, 50 min/session, for 12 weeks (≥150 min/week). The program provides grip strength-based automatic intensity adjustment, exercise recording, feedback, and physician monitoring.

Delivery: Nonpharmacological, non-invasive, home-based exercise program. The experimental group uses a mobile app; the control group uses educational materials.

Initial instruction occurs on-site. Visits & Monitoring: Screening/Baseline (week 0), In-treatment (weeks 4, 8), Post-treatment (week 12), and Follow-up (week 24).
Comparateur actif: Control Group (Self-exercise)

No mobile application is used. Participants perform the same type of exercise using QR code-based educational materials, self-regulating their exercise time, at least 3 times per week, 50 minutes per session, for a total of 12 weeks, with frequency and duration identical to the experimental group.
Comportemental: Self-exercise (Educational Material)

Control group (Self-exercise): No app is used. Participants perform the same exercise guided by QR code-based educational materials, ≥3 times/week, 50min/session, for 12 weeks, maintaining exercise logs without automatic adjustment or remote monitoring.

Delivery: Non-pharmacological, non-invasive, homebased exercise program. The experimental group uses a mobile app; the control group uses educational materials. Initial instruction occurs on-site. Visits & Monitoring: Screening/Baseline (week 0), In-treatment (weeks 4, 8), Post-treatment (week 12), and Follow-up (week 24).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in peak knee extension strength (Nm) from baseline to 12 weeks
Délai: 12 weeks after Visit 1 (treatment initiation)

Between-group comparison of mean change in knee extensor strength measured by lower extremity dynamometer.
12 weeks after Visit 1 (treatment initiation)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in peak isometric knee extension strength (Nm) from baseline to 4, 8, and 24 weeks
Délai: Baseline, 4 weeks, 8 weeks, and 24 weeks after Visit 1 (treatment initiation)

To evaluate longitudinal changes in knee extensor muscle strength at weeks 4, 8, and 24 compared with baseline using an lower extremity dynamometer.
Baseline, 4 weeks, 8 weeks, and 24 weeks after Visit 1 (treatment initiation)
Change in body composition (skeletal muscle mass index, fat mass)
Délai: 12 weeks after Visit 1 (treatment initiation)

To evaluate changes in muscle and fat mass measured by dual-energy x-ray absorptiometry(DXA) or bioelectrical impedance analysis (BIA) after 12 weeks of intervention.
12 weeks after Visit 1 (treatment initiation)
Change in Manual Muscle Test (MMT) scores of major limb muscles
Délai: 12 weeks after Visit 1 (treatment initiation)

To assess changes in muscle strength based on standardized MMT grading (0-5 scale) after 12 weeks of intervention..
12 weeks after Visit 1 (treatment initiation)
Change in handgrip strength (kg) from baseline
Délai: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks

To assess longitudinal changes in handgrip strength measured by hand dynamometer at weeks 4, 8, 12, and 24.
Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks
Change in calf circumference (cm) from baseline
Délai: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks

To assess longitudinal changes in calf circumference measured at the maximum girth of the dominant or less-affected lower leg at weeks 4, 8, 12, and 24.
Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks
Change in Muscle Function Index (MFI) from surface EMG analysis
Délai: 12 weeks after Visit 1 (treatment initiation)

To quantify changes in muscle fatigue characteristics derived from surface electromyography (EMG) during resistance exercises.
12 weeks after Visit 1 (treatment initiation)
Change in Fugl-Meyer Assessment (upper/lower extremities; CNS-related sarcopenia subgroup)
Délai: 12 weeks after Visit 1 (treatment initiation)

To examine motor recovery and coordination improvements using the Fugl-Meyer Assessment in participants with CNS-related sarcopenia.
12 weeks after Visit 1 (treatment initiation)
Change in 30-second chair stand test (repetitions) from baseline
Délai: 12 weeks after Visit 1 (treatment initiation)

To assess changes in lower limb functional strength and endurance measured by the number of sit-to-stand repetitions completed in 30 seconds after 12 weeks of intervention.
12 weeks after Visit 1 (treatment initiation)
Change in Functional Ambulation Category (FAC) score
Délai: 12 weeks after Visit 1 (treatment initiation)

To assess improvement in walking independence level using the Functional Ambulation Category (0-5 scale).
12 weeks after Visit 1 (treatment initiation)
Change in Berg Balance Scale (BBS) and Timed Up and Go (TUG) performance
Délai: 12 weeks after Visit 1 (treatment initiation)

To evaluate dynamic and static balance performance using BBS score and TUG test time.
12 weeks after Visit 1 (treatment initiation)
Change in Short Physical Performance Battery (SPPB) total score and subscores (chair stand, gait speed, balance)
Délai: 12 weeks after Visit 1 (treatment initiation)

To assess lower extremity function using SPPB, including 5-time chair stand, 6-meter gait speed, and balance tests.

SPPB - 5-time chair stand (time) 6-meter gait speed (SPPB gait speed) SPPB balance - score SPPB balance - time in seconds
12 weeks after Visit 1 (treatment initiation)
Change in Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls Questionnaire Score
Délai: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks

To assess changes in self-reported sarcopenia risk using the full Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls questionnaire. The SARC-F consists of 5 items, each scored from 0 to 2, resulting in a total score ranging from 0 to 10, with higher scores indicating worse sarcopenia severity and greater functional limitation.
Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks
Change in Sarcopenia Quality of Life score
Délai: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks

To measure sarcopenia-specific quality of life changes using Sarcopenia Quality of Life total score and domain subscores.

Sarcopenia Quality of Life contains 55 items generating a total score from 0 to 100, with higher scores indicating better quality of life.
Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks
Change in EuroQol Five-Dimension Five-Level (EQ-5D-5L) Questionnaire Score
Délai: 12 weeks after Visit 1 (treatment initiation)

To assess changes in self-reported health-related quality of life using the full EuroQol Five-Dimension Five-Level (EQ-5D-5L) questionnaire. The EQ-5D-5L consists of 5 items, each scored from 1 to 5, resulting in a total score ranging from 5 to 25, with lower scores indicating better health-related quality of life and higher scores indicating greater health impairment.
12 weeks after Visit 1 (treatment initiation)
Change in Self-Efficacy for Home Exercise Programs Scale score
Délai: 12 weeks after Visit 1 (treatment initiation)

To evaluate participants' confidence in independently performing prescribed home-based exercises.
12 weeks after Visit 1 (treatment initiation)
System Usability Scale (SUS) total score of the exoDTx mobile application
Délai: 12 weeks after Visit 1 (treatment initiation)

To assess user satisfaction and perceived usability of the exoDTx digital therapeutic application using SUS.
12 weeks after Visit 1 (treatment initiation)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Exosystems

Collaborateurs

The Catholic University of Korea

Les enquêteurs

  • Chercheur principal: Sangui Choi, CPO, Exosystems

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

28 novembre 2025

Achèvement primaire (Réel)

23 septembre 2026

Achèvement de l'étude (Estimé)

10 décembre 2026

Dates d'inscription aux études

Première soumission

20 novembre 2025

Première soumission répondant aux critères de contrôle qualité

21 décembre 2025

Première publication (Réel)

6 janvier 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HC25DDDS0072

Plan pour les données individuelles des participants (IPD)

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NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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