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

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 Overview

• Status: Recruiting
• Conditions: Heart Failure, Systolic
• Intervention / Treatment: Device: Myosuit robotic device

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabell A Just, MD; Phone Number: 00493045932025; Email: herzsport@dhzb.de

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • German Heart Center
    • Contact: I A Just, MD; Phone Number: 00493045932025; Email: ijust@dhzb.de
    • Contact: F Schoenrath; Phone Number: 00493045932085; Email: schoenrath@dhzb.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Myosuit arm; Patients perform exercise training with the Myosuit	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.
Other: Control arm; Patients perform exercise training without the Myosuit	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: German Heart Institute
• Collaborators: Charite University, Berlin, Germany; ETH Zurich

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 13, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Exercise training; Robotic training
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Heart Failure, Systolic
• Other Study ID Numbers: Myosuit Efficacy Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No