Robotic-assisted Exercise Training in Heart Failure

German Heart Institute

Status

Completed

Conditions

Heart Failure, Systolic

Pulmonary Disease

Treatments

Device: MyoSuitFeasibility

Study type

Interventional

Funder types

Other

Identifiers

NCT04839133

MyoSuit Feasibility Trial

Details and patient eligibility

About

Background:

Regular physical activity is an evidence-based adjuvant therapy of chronic heart failure or chronic lung diseases. Structured exercise training is safe, increases exercise capacity and quality of life, relieves symptoms and reduces hospitalization rates. Even a trend towards reduction of mortality has been identified. However, dyspnea and fatigue, typical symptoms of heart or lung failure, force patients to physical inactivity which fatally aggravates deconditioning and exercise intolerance, leading to an increased risk of hospitalization and a loss of independence and quality of life. To break through this vicious circle physical activity must be restored, since exercise intolerance can be successfully improved by physical training.

Purpose:

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 (fig. 1) assists mobilization according to individual needs by activating neuromuscular feedback systems, promoting physical activity and preventing early physical exhaustion. The investigators hypotheses that an exosuit-supported training increases exercise capacity and quality of life in a greater degree than non-supported training.

Methods:

The study will consist of two parts investigating i) the feasibility, tolerance and safety (n= 30) and ii) the efficacy of an exosuit device-supported training (n=30). In i) patients will perform a walking test and a set of everyday life skills or participate in a standardized rehabilitation sports program. In ii) 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 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% OR chronic advanced pulmonary diseases
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