Health TrialsbyHealthPanel

Evaluation of Safety and Efficacy of a Digital Therapeutic Device to Improve Strength in Sarcopenia (Sarc-DTx)

ConditionSarcopenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorExosystems

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Handgrip strength < 28 kg for men or < 18 kg for women

Five-times Sit-to-Stand Test time > 12 seconds without arm support

Skeletal Muscle Mass Index (SMI) < 7.0 kg/m² for men or < 5.4 kg/m² for women measured by DXA

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • exoDTx

    Device

    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).

  • Self-exercise (Educational Material)

    Behavioral

    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).

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Experimental Device Group (Home-based DTx exercise group after training)Experimental treatment 1 intervention
Group B: Control Group (Self-exercise)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in peak knee extension strength (Nm) from baseline to 12 weeks

Between-group comparison of mean change in knee extensor strength measured by lower extremity dynamometer.

Time frame
12 weeks after Visit 1 (treatment initiation)

Secondary outcomes

1

Change in peak isometric knee extension strength (Nm) from baseline to 4, 8, and 24 weeks

To evaluate longitudinal changes in knee extensor muscle strength at weeks 4, 8, and 24 compared with baseline using an lower extremity dynamometer.

Time frame
Baseline, 4 weeks, 8 weeks, and 24 weeks after Visit 1 (treatment initiation)
2

Change in body composition (skeletal muscle mass index, fat mass)

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.

Time frame
12 weeks after Visit 1 (treatment initiation)
3

Change in Manual Muscle Test (MMT) scores of major limb muscles

To assess changes in muscle strength based on standardized MMT grading (0-5 scale) after 12 weeks of intervention..

Time frame
12 weeks after Visit 1 (treatment initiation)
4

Change in handgrip strength (kg) from baseline

To assess longitudinal changes in handgrip strength measured by hand dynamometer at weeks 4, 8, 12, and 24.

Time frame
Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Exosystems

Lead sponsor

The Catholic University of Korea

Collaborator

Source ClinicalTrials.gov
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