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

NCT05278429 | Recruiting

• 1 other identifier: Myosuit Efficacy Trial
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure, Systolic

Keywords

Exercise training; Robotic training

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (1)

• Device acceptability

  8 weeks

Study Arms (2)

Myosuit arm

ACTIVE COMPARATOR

Patients perform exercise training with the Myosuit

Device: Myosuit robotic device

Control arm

OTHER

Patients perform exercise training without the Myosuit

Device: Myosuit robotic device

Interventions

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.

Control arm; Myosuit arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• German Heart Institute: lead
• ETH Zurich: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

German Heart Center

Berlin, 13353, Germany

RECRUITING

MeSH Terms

Conditions

Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Isabell A Just, MD

CONTACT

00493045932025; herzsport@dhzb.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: March 14, 2022
• Study Start: November 1, 2021
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)