No phaseActive, not recruiting
Evaluation of Safety and Efficacy of a Digital Therapeutic Device to Improve Strength in Sarcopenia (Sarc-DTx)
A Multicenter, Prospective, Randomized, Parallel-Group, Double-blinded, Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of a Digital Therapeutic Device for Improving Muscle Strength in Patients With Sarcopenia
- Sponsor
- Exosystems (Industry)
- Enrolment
- 130 planned
- Conditions
- Sarcopenia
- Interventions
- exoDTx; Self-exercise (Educational Material)
- Ages
- adults, older adults
- Registry
- NCT07319377
From the registry
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.
Primary outcomes
- Change in peak knee extension strength (Nm) from baseline to 12 weeks