Status:
RECRUITING
Robotic-assisted Exercise Training in Heart Failure With Reduced Ejection Fraction
Lead Sponsor:
German Heart Institute
Collaborating Sponsors:
ETH Zurich
Charite University, Berlin, Germany
Conditions:
Heart Failure, Systolic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 physica...
Eligibility Criteria
Inclusion
- \>17 years old
- written informed consent
- chronic end-stage systolic heart failure without ventricular assist device, LVEF ≤ 45%
- clinically stable for at least 6 weeks
- ability to mobilize into standing and walking of at least 10 meters with or without rollator
- ability to get up from a chair without rotating the upper body \>45° sagittally
Exclusion
- addictions or other illnesses that impact the ability to understand the nature, scope and
- consequences of the trial
- lack of knowledge of German to fully understand study information
- pregnancy, pre-menopausal women
- contraindications of cardiopulmonary exercising
- BMI \> 35 kg/m², waist size \> 135 cm.
- Height \<150 cm, \>195 cm
- Weight\<45 kg, \>110 kg
- Functional Reach Test \<15,24 cm
- Flexion contracture in the knee/hip joint \>10°
- Chronic colonization or active infection with multi-resistant pathogens
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05278429
Start Date
November 1 2021
End Date
January 1 2025
Last Update
April 16 2024
Active Locations (1)
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1
German Heart Center
Berlin, Germany, 13353