Robotic-assisted Exercise Training in Heart Failure With Reduced Ejection Fraction
- Conditions
- Heart Failure, Systolic
- Interventions
- Device: Myosuit robotic device
- Registration Number
- NCT05278429
- Lead Sponsor
- German Heart Institute
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- >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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Myosuit arm Myosuit robotic device Patients perform exercise training with the Myosuit Control arm Myosuit robotic device Patients perform exercise training without the Myosuit
- Primary Outcome Measures
Name Time Method Mobility improves more in patients who trained with robotic support 4 weeks Mobility is measured by timed-up-and-go tests in seconds
Exercise capacity improves more in patients who trained with robotic support 4 weeks Exercise capacity is measured by six-minute walking test in meters
Balance improves more in patients who trained with robotic support 4 weeks Balance is measured by berg balance tests via berg balance scale(0-56 points, the higher, the better).
Heart failure Progression: Ejection fractions 4 weeks Change of echocardiographic findings: ejection fraction (in %)
Change in Heart failure biomarkers: hsTroponin 8 weeks Heart failure biomarkers: hsTroponin
Heart failure Progression: valve regurgitations 8 weeks Change of echocardiographic findings: regurgitations (grad I-V)
Exercise training improves quality of life 8 weeks Quality of life is measured by Kansas City Cardiomyopathy Questionnaire
Heart failure Progression: Diameters 8 weeks Change of echocardiographic findings: diameters (in mm)
Heart failure Progression: elevated filling pressures 8 weeks Change of echocardiographic findings: end-diastolic pressure (elevated or normal)
Heart failure Progression: volume status 8 weeks Change of echocardiographic findings: vena cava diameter (in mm)
Change in Heart failure biomarkers: NT-proBNP 8 weeks Heart failure biomarkers: NT-proBNP
Change in inflammatory biomarkers: hsCRP 8 weeks Inflammatory biomarkers: NT-proBNP (in ng/mL)
Change in inflammatory biomarkers: IL-6 8 weeks Inflammatory biomarkers: IL-6
- Secondary Outcome Measures
Name Time Method Device acceptability 8 weeks measured by a acceptability questionnaire (9 questions, Score 9 to 63, the higher, the better).
Trial Locations
- Locations (1)
German Heart Center
🇩🇪Berlin, Germany