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

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Failure, Systolic

Intervention / Treatment
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* Device: Myosuit robotic device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Myosuit arm<br>Patients perform exercise training with the Myosuit | Device: Myosuit robotic device<br>* The Myosuit is a partially soft, exoskeleton-type, wearable robot that supports the synergistic extension of the hip and knee joints.<br>|
| Other: Control arm<br>Patients perform exercise training without the Myosuit | Device: Myosuit robotic device<br>* The Myosuit is a partially soft, exoskeleton-type, wearable robot that supports the synergistic extension of the hip and knee joints.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity improves more in patients who trained with robotic support | Exercise capacity is measured by six-minute walking test in meters | 8 weeks | 
| Exercise capacity improves more in patients who trained with robotic support | Exercise capacity is measured by six-minute walking test in meters | 4 weeks | 
| Mobility improves more in patients who trained with robotic support | Mobility is measured by timed-up-and-go tests in seconds | 8 weeks | 
| Mobility improves more in patients who trained with robotic support | Mobility is measured by timed-up-and-go tests in seconds | 4 weeks | 
| 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 | 
| 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 | 
| Exercise training improves quality of life | Quality of life is measured by Kansas City Cardiomyopathy Questionnaire | 8 weeks | 
| Heart failure Progression: Ejection fractions | Change of echocardiographic findings: ejection fraction (in %) | 4 weeks | 
| Heart failure Progression: Diameters | Change of echocardiographic findings: diameters (in mm) | 8 weeks | 
| Heart failure Progression: valve regurgitations | Change of echocardiographic findings: regurgitations (grad I-V) | 8 weeks | 
| Heart failure Progression: elevated filling pressures | Change of echocardiographic findings: end-diastolic pressure (elevated or normal) | 8 weeks | 
| Heart failure Progression: volume status | Change of echocardiographic findings: vena cava diameter (in mm) | 8 weeks | 
| Change in Heart failure biomarkers: NT-proBNP | Heart failure biomarkers: NT-proBNP | 8 weeks | 
| Change in Heart failure biomarkers: hsTroponin | Heart failure biomarkers: hsTroponin | 8 weeks | 
| Change in inflammatory biomarkers: hsCRP | Inflammatory biomarkers: NT-proBNP (in ng/mL) | 8 weeks | 
| Change in inflammatory biomarkers: IL-6 | Inflammatory biomarkers: IL-6 | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device acceptability | measured by a acceptability questionnaire (9 questions, Score 9 to 63, the higher, the better). | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise training, Robotic training