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
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
Treatments tested in this trial
- exoDTx
- Self-exercise (Educational Material)
Treatment groups
130 Participants
are divided into 2 treatment groupsSponsors and collaborators
Exosystems
Lead sponsor
The Catholic University of Korea
Collaborator
Source ClinicalTrials.gov