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

German Heart Institute30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure, Systolic

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Exercise capacity improves more in patients who trained with robotic support

Exercise capacity is measured by six-minute walking test in meters

Time frame: 8 weeks

Exercise capacity improves more in patients who trained with robotic support

Exercise capacity is measured by six-minute walking test in meters

Time frame: 4 weeks

Mobility improves more in patients who trained with robotic support

Mobility is measured by timed-up-and-go tests in seconds

Time frame: 8 weeks

Mobility improves more in patients who trained with robotic support

Mobility is measured by timed-up-and-go tests in seconds

Time frame: 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).

Time frame: 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).

Time frame: 4 weeks

Exercise training improves quality of life

Quality of life is measured by Kansas City Cardiomyopathy Questionnaire

Time frame: 8 weeks

Heart failure Progression: Ejection fractions

Change of echocardiographic findings: ejection fraction (in %)

Time frame: 4 weeks

Heart failure Progression: Diameters

Change of echocardiographic findings: diameters (in mm)

Time frame: 8 weeks

Heart failure Progression: valve regurgitations

Change of echocardiographic findings: regurgitations (grad I-V)

Time frame: 8 weeks

Heart failure Progression: elevated filling pressures

Change of echocardiographic findings: end-diastolic pressure (elevated or normal)

Time frame: 8 weeks

Heart failure Progression: volume status

Change of echocardiographic findings: vena cava diameter (in mm)

Time frame: 8 weeks

Change in Heart failure biomarkers: NT-proBNP

Heart failure biomarkers: NT-proBNP

Time frame: 8 weeks

Change in Heart failure biomarkers: hsTroponin

Heart failure biomarkers: hsTroponin

Time frame: 8 weeks

Change in inflammatory biomarkers: hsCRP

Inflammatory biomarkers: NT-proBNP (in ng/mL)

Time frame: 8 weeks

Change in inflammatory biomarkers: IL-6

Inflammatory biomarkers: IL-6

Time frame: 8 weeks

Secondary Outcomes

Device acceptability

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

Time frame: 8 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts