Robotic exercise training for patients with heart failure
Robotic-assisted Exercise Training in Heart Failure With Reduced Ejection Fraction
This study is testing whether a robotic exosuit can help people with advanced heart failure improve their movement and activity levels compared to regular exercise.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | German Heart Institute Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT05278429 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of a robotic exosuit, known as Myosuit, to assist patients with advanced chronic heart failure in improving their mobility and physical activity. Participants will be randomized into two groups: one receiving exosuit-supported exercise training and the other following a non-supported protocol, with training sessions occurring three times a week for eight weeks. The study aims to assess the feasibility, safety, and efficacy of this intervention through various functional and mobility tests, as well as questionnaires to evaluate the transfer of skills to daily life.
Who should consider this trial
Good fit: Ideal candidates include adults over 17 years old with chronic end-stage systolic heart failure and a left ventricular ejection fraction of 45% or less.
Not a fit: Patients with contraindications to cardiopulmonary exercise or those with significant obesity or mobility limitations may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the mobility and quality of life for patients suffering from heart failure.
How similar studies have performed: Previous feasibility trials have shown promise for robotic-assisted training in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Berlin
- German Heart Center — Berlin, Germany (Recruiting)
Study contacts
- Study coordinator: Isabell A Just, MD
- Email: herzsport@dhzb.de
- Phone: 00493045932025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.