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

Heart Failure, Systolic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05278429
• Other study ID #: Myosuit Efficacy Trial
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: German Heart Institute
• Contact: Isabell A Just, MD
• Phone: 00493045932025
• Email: herzsport[@]dhzb.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >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 Criteria:

• 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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic

Intervention

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

Country	Name	City	State
Germany	German Heart Center	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
German Heart Institute	Charite University, Berlin, Germany, ETH Zurich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise capacity improves more in patients who trained with robotic support	Exercise capacity is measured by six-minute walking test in meters	8 weeks
Primary	Exercise capacity improves more in patients who trained with robotic support	Exercise capacity is measured by six-minute walking test in meters	4 weeks
Primary	Mobility improves more in patients who trained with robotic support	Mobility is measured by timed-up-and-go tests in seconds	8 weeks
Primary	Mobility improves more in patients who trained with robotic support	Mobility is measured by timed-up-and-go tests in seconds	4 weeks
Primary	Balance improves more in patients who trained with robotic support	Balance is measured by berg balance tests via berg balance scale (0-56 points, the higher, the better).	8 weeks
Primary	Balance improves more in patients who trained with robotic support	Balance is measured by berg balance tests via berg balance scale(0-56 points, the higher, the better).	4 weeks
Primary	Exercise training improves quality of life	Quality of life is measured by Kansas City Cardiomyopathy Questionnaire	8 weeks
Primary	Heart failure Progression: Ejection fractions	Change of echocardiographic findings: ejection fraction (in %)	4 weeks
Primary	Heart failure Progression: Diameters	Change of echocardiographic findings: diameters (in mm)	8 weeks
Primary	Heart failure Progression: valve regurgitations	Change of echocardiographic findings: regurgitations (grad I-V)	8 weeks
Primary	Heart failure Progression: elevated filling pressures	Change of echocardiographic findings: end-diastolic pressure (elevated or normal)	8 weeks
Primary	Heart failure Progression: volume status	Change of echocardiographic findings: vena cava diameter (in mm)	8 weeks
Primary	Change in Heart failure biomarkers: NT-proBNP	Heart failure biomarkers: NT-proBNP	8 weeks
Primary	Change in Heart failure biomarkers: hsTroponin	Heart failure biomarkers: hsTroponin	8 weeks
Primary	Change in inflammatory biomarkers: hsCRP	Inflammatory biomarkers: NT-proBNP (in ng/mL)	8 weeks
Primary	Change in inflammatory biomarkers: IL-6	Inflammatory biomarkers: IL-6	8 weeks
Secondary	Device acceptability	measured by a acceptability questionnaire (9 questions, Score 9 to 63, the higher, the better).	8 weeks