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

Primary Purpose

Heart Failure, Systolic

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Myosuit robotic device
Sponsored by
German Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Systolic focused on measuring Exercise training, Robotic training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • German Heart CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Myosuit arm

Control arm

Arm Description

Patients perform exercise training with the Myosuit

Patients perform exercise training without the Myosuit

Outcomes

Primary Outcome Measures

Exercise capacity improves more in patients who trained with robotic support
Exercise capacity is measured by six-minute walking test in meters
Exercise capacity improves more in patients who trained with robotic support
Exercise capacity is measured by six-minute walking test in meters
Mobility improves more in patients who trained with robotic support
Mobility is measured by timed-up-and-go tests in seconds
Mobility improves more in patients who trained with robotic support
Mobility is measured by timed-up-and-go tests in seconds
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).
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).
Exercise training improves quality of life
Quality of life is measured by Kansas City Cardiomyopathy Questionnaire
Heart failure Progression: Ejection fractions
Change of echocardiographic findings: ejection fraction (in %)
Heart failure Progression: Diameters
Change of echocardiographic findings: diameters (in mm)
Heart failure Progression: valve regurgitations
Change of echocardiographic findings: regurgitations (grad I-V)
Heart failure Progression: elevated filling pressures
Change of echocardiographic findings: end-diastolic pressure (elevated or normal)
Heart failure Progression: volume status
Change of echocardiographic findings: vena cava diameter (in mm)
Change in Heart failure biomarkers: NT-proBNP
Heart failure biomarkers: NT-proBNP
Change in Heart failure biomarkers: hsTroponin
Heart failure biomarkers: hsTroponin
Change in inflammatory biomarkers: hsCRP
Inflammatory biomarkers: NT-proBNP (in ng/mL)
Change in inflammatory biomarkers: IL-6
Inflammatory biomarkers: IL-6

Secondary Outcome Measures

Device acceptability
measured by a acceptability questionnaire (9 questions, Score 9 to 63, the higher, the better).

Full Information

First Posted
November 16, 2021
Last Updated
March 3, 2022
Sponsor
German Heart Institute
Collaborators
ETH Zurich, Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT05278429
Brief Title
Robotic-assisted Exercise Training in Heart Failure With Reduced Ejection Fraction
Official Title
Robotic-assisted Exercise Training in Heart Failure With Reduced Ejection Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
German Heart Institute
Collaborators
ETH Zurich, Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic
Keywords
Exercise training, Robotic training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Myosuit arm
Arm Type
Active Comparator
Arm Description
Patients perform exercise training with the Myosuit
Arm Title
Control arm
Arm Type
Other
Arm Description
Patients perform exercise training without the Myosuit
Intervention Type
Device
Intervention Name(s)
Myosuit robotic device
Intervention Description
The Myosuit is a partially soft, exoskeleton-type, wearable robot that supports the synergistic extension of the hip and knee joints.
Primary Outcome Measure Information:
Title
Exercise capacity improves more in patients who trained with robotic support
Description
Exercise capacity is measured by six-minute walking test in meters
Time Frame
8 weeks
Title
Exercise capacity improves more in patients who trained with robotic support
Description
Exercise capacity is measured by six-minute walking test in meters
Time Frame
4 weeks
Title
Mobility improves more in patients who trained with robotic support
Description
Mobility is measured by timed-up-and-go tests in seconds
Time Frame
8 weeks
Title
Mobility improves more in patients who trained with robotic support
Description
Mobility is measured by timed-up-and-go tests in seconds
Time Frame
4 weeks
Title
Balance improves more in patients who trained with robotic support
Description
Balance is measured by berg balance tests via berg balance scale (0-56 points, the higher, the better).
Time Frame
8 weeks
Title
Balance improves more in patients who trained with robotic support
Description
Balance is measured by berg balance tests via berg balance scale(0-56 points, the higher, the better).
Time Frame
4 weeks
Title
Exercise training improves quality of life
Description
Quality of life is measured by Kansas City Cardiomyopathy Questionnaire
Time Frame
8 weeks
Title
Heart failure Progression: Ejection fractions
Description
Change of echocardiographic findings: ejection fraction (in %)
Time Frame
4 weeks
Title
Heart failure Progression: Diameters
Description
Change of echocardiographic findings: diameters (in mm)
Time Frame
8 weeks
Title
Heart failure Progression: valve regurgitations
Description
Change of echocardiographic findings: regurgitations (grad I-V)
Time Frame
8 weeks
Title
Heart failure Progression: elevated filling pressures
Description
Change of echocardiographic findings: end-diastolic pressure (elevated or normal)
Time Frame
8 weeks
Title
Heart failure Progression: volume status
Description
Change of echocardiographic findings: vena cava diameter (in mm)
Time Frame
8 weeks
Title
Change in Heart failure biomarkers: NT-proBNP
Description
Heart failure biomarkers: NT-proBNP
Time Frame
8 weeks
Title
Change in Heart failure biomarkers: hsTroponin
Description
Heart failure biomarkers: hsTroponin
Time Frame
8 weeks
Title
Change in inflammatory biomarkers: hsCRP
Description
Inflammatory biomarkers: NT-proBNP (in ng/mL)
Time Frame
8 weeks
Title
Change in inflammatory biomarkers: IL-6
Description
Inflammatory biomarkers: IL-6
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Device acceptability
Description
measured by a acceptability questionnaire (9 questions, Score 9 to 63, the higher, the better).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabell A Just, MD
Phone
00493045932025
Email
herzsport@dhzb.de
Facility Information:
Facility Name
German Heart Center
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
I A Just, MD
Phone
00493045932025
Email
ijust@dhzb.de
First Name & Middle Initial & Last Name & Degree
F Schoenrath
Phone
00493045932085
Email
schoenrath@dhzb.de

12. IPD Sharing Statement

Plan to Share IPD
No

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

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