Clinical trial NCT05278429: 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
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure, Systolic
Keywords: Exercise training
Robotic training
Lead sponsor: German Heart Institute
Sponsor class: OTHER
Collaborators: name: ETH Zurich
name: Charite University, Berlin, Germany
First posted: 2022-03-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Exercise capacity improves more in patients who trained with robotic support
timeFrame: 8 weeks
measure: Exercise capacity improves more in patients who trained with robotic support
timeFrame: 4 weeks
measure: Mobility improves more in patients who trained with robotic support
timeFrame: 8 weeks
measure: Mobility improves more in patients who trained with robotic support
timeFrame: 4 weeks
measure: Balance improves more in patients who trained with robotic support
timeFrame: 8 weeks
measure: Balance improves more in patients who trained with robotic support
timeFrame: 4 weeks
measure: Exercise training improves quality of life
timeFrame: 8 weeks
measure: Heart failure Progression: Ejection fractions
timeFrame: 4 weeks
measure: Heart failure Progression: Diameters
timeFrame: 8 weeks
measure: Heart failure Progression: valve regurgitations
timeFrame: 8 weeks
measure: Heart failure Progression: elevated filling pressures
timeFrame: 8 weeks
measure: Heart failure Progression: volume status
timeFrame: 8 weeks
measure: Change in Heart failure biomarkers: NT-proBNP
timeFrame: 8 weeks
measure: Change in Heart failure biomarkers: hsTroponin
timeFrame: 8 weeks
measure: Change in inflammatory biomarkers: hsCRP
timeFrame: 8 weeks
measure: Change in inflammatory biomarkers: IL-6
timeFrame: 8 weeks
Secondary outcomes:
measure: Device acceptability
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: German Heart Center
Study officials:
References: