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Robotic-assisted Exercise Training in Heart Failure With Reduced Ejection Fraction

NCT05278429 · German Heart Institute · Updated 16 April 2024

What is being tested
Myosuit robotic device
For
Heart Failure, Systolic
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 30 people. The full rules are on the registry page.
Where
Germany
When
Starts or started 1 Nov 2021, ends Jan 2025. Registered 14 March 2022.
Results
None posted yet.

In the researchers' words

This study will address the challenging task of remobilizing patients with advanced chronic lung or heart failure in a functional New York Heart Association class III-IV by using an externally physically-supported exosuit movement therapy. This soft, wearable robot (Myosuit) assists mobilization according to individual needs by activating neuromuscular feedback systems, promoting physical activity and preventing early physical exhaustion. The feasibility, tolerance and safety of a Myosuit assisted training was shown in a feasibility trial. In the efficacy trial, patients will be randomized in a 2:1 ratio for an exosuit-supported or non-supported exercise training protocol, training 3 units per week for 8 weeks. Assessment of outcome will be performed by various functional, mobility and endurance tests, questionnaires and clinical parameters. Furthermore, the transfer of regained motor and balance skills to everyday life will be analyzed.
ClinicalTrials.gov, NCT05278429

Sites

  • German Heart CenterBerlin, Germany