Robotic-assisted Exercise Training in Heart Failure With Reduced Ejection Fraction
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Mobility improves more in patients who trained with robotic support
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Mobility improves more in patients who trained with robotic support
Time Frame: 4 weeks
Mobility is measured by timed-up-and-go tests in seconds
Exercise capacity improves more in patients who trained with robotic support
Time Frame: 4 weeks
Exercise capacity is measured by six-minute walking test in meters
Balance improves more in patients who trained with robotic support
Time Frame: 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
Time Frame: 4 weeks
Change of echocardiographic findings: ejection fraction (in %)
Change in Heart failure biomarkers: hsTroponin
Time Frame: 8 weeks
Heart failure biomarkers: hsTroponin
Exercise training improves quality of life
Time Frame: 8 weeks
Quality of life is measured by Kansas City Cardiomyopathy Questionnaire
Heart failure Progression: valve regurgitations
Time Frame: 8 weeks
Change of echocardiographic findings: regurgitations (grad I-V)
Heart failure Progression: Diameters
Time Frame: 8 weeks
Change of echocardiographic findings: diameters (in mm)
Heart failure Progression: elevated filling pressures
Time Frame: 8 weeks
Change of echocardiographic findings: end-diastolic pressure (elevated or normal)
Heart failure Progression: volume status
Time Frame: 8 weeks
Change of echocardiographic findings: vena cava diameter (in mm)
Change in Heart failure biomarkers: NT-proBNP
Time Frame: 8 weeks
Heart failure biomarkers: NT-proBNP
Change in inflammatory biomarkers: hsCRP
Time Frame: 8 weeks
Inflammatory biomarkers: NT-proBNP (in ng/mL)
Change in inflammatory biomarkers: IL-6
Time Frame: 8 weeks
Inflammatory biomarkers: IL-6
Secondary Outcomes
- Device acceptability(8 weeks)