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| Name | Class |
|---|---|
| ETH Zurich | OTHER |
| Charite University, Berlin, Germany | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myosuit arm | Active Comparator | Patients perform exercise training with the Myosuit |
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| Control arm | Other | Patients perform exercise training without the Myosuit |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myosuit robotic device | Device | The Myosuit is a partially soft, exoskeleton-type, wearable robot that supports the synergistic extension of the hip and knee joints. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Device acceptability | measured by a acceptability questionnaire (9 questions, Score 9 to 63, the higher, the better). | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabell A Just, MD | Contact | 00493045932025 | herzsport@dhzb.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German Heart Center | Recruiting | Berlin | 13353 | Germany |
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| ID | Term |
|---|---|
| D054143 | Heart Failure, Systolic |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |