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

Last updated: April 13, 2024
Sponsor: German Heart Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

Myosuit robotic device

Clinical Study ID

NCT05278429
Myosuit Efficacy Trial
  • Ages > 18
  • All Genders

Study 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

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 withoutrollator
  • ability to get up from a chair without rotating the upper body >45° sagittally

Exclusion

Exclusion Criteria:

  • addictions or other illnesses that impact the ability to understand the nature, scopeand
  • 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

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Myosuit robotic device
Phase:
Study Start date:
November 01, 2021
Estimated Completion Date:
January 31, 2025

Connect with a study center

  • German Heart Center

    Berlin, 13353
    Germany

    Active - Recruiting

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