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RECRUITING
NCT05278429
NA

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

Sponsor: German Heart Institute

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2021-11-01

Completion Date

2025-01

Last Updated

2024-04-16

Healthy Volunteers

No

Interventions

DEVICE

Myosuit robotic device

The Myosuit is a partially soft, exoskeleton-type, wearable robot that supports the synergistic extension of the hip and knee joints.

Locations (1)

German Heart Center

Berlin, Germany