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

G

German Heart Institute

Status

Enrolling

Conditions

Heart Failure, Systolic

Treatments

Device: Myosuit robotic device

Study type

Interventional

Funder types

Other

Identifiers

NCT05278429
Myosuit Efficacy Trial

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Myosuit arm
Active Comparator group
Description:
Patients perform exercise training with the Myosuit
Treatment:
Device: Myosuit robotic device
Control arm
Other group
Description:
Patients perform exercise training without the Myosuit
Treatment:
Device: Myosuit robotic device

Trial contacts and locations

1

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Central trial contact

Isabell A Just, MD

Data sourced from clinicaltrials.gov

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