RecruitingNot ApplicableNCT05278429

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

Sponsor

German Heart Institute

Enrollment

30 participants

Start Date

Nov 1, 2021

Study Type

INTERVENTIONAL

Conditions

Heart Failure, Systolic

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether robotic-assisted walking exercise (using a robotic exoskeleton device) is safe and effective for people with severe heart failure who have a weakened heart pump. The goal is to help patients exercise more safely and potentially improve their strength and function. **You may be eligible if...** - You are over 17 years old - You have chronic, severe heart failure with a reduced ejection fraction (the heart pumps weakly, 45% or less) - Your condition has been stable for at least 6 weeks - You are able to stand and walk at least 10 meters (with or without a walking frame) **You may NOT be eligible if...** - You are pregnant or pre-menopausal - You have a BMI over 35, a very small or very tall frame, or weigh less than 45 kg or more than 110 kg - You have significant joint contractures in the hip or knee - You have a serious active infection - You speak no German (the study is conducted in German) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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