Heart Failure, SystolicNCT05278429
Robotic-assisted Exercise Training in Heart Failure With Reduced Ejection Fraction
A study testing Myosuit robotic device in people with Heart Failure, Systolic, run by German Heart Institute at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Systolic
- What is being tested?
- Myosuit robotic device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2021to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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.
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
German Heart Center
Berlin, 13353
I A Just, MD, 00493045932025, ijust@dhzb.de
F Schoenrath, 00493045932085, schoenrath@dhzb.de
About this study
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.
- Conditions
- Heart Failure, Systolic
- Being tested
- Myosuit robotic device
- Keywords
- Exercise training, Robotic training
- Medical subject headings
- Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myosuit robotic deviceDevice
The Myosuit is a partially soft, exoskeleton-type, wearable robot that supports the synergistic extension of the hip and knee joints.
| Study group | Role | What they receive |
|---|---|---|
| Myosuit arm | Active comparator | Patients perform exercise training with the Myosuit Receives: Device: Myosuit robotic device |
| Control arm | Other | Patients perform exercise training without the Myosuit Receives: Device: Myosuit robotic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity improves more in patients who trained with robotic support
Exercise capacity is measured by six-minute walking test in meters
Measured: 8 weeks
Exercise capacity improves more in patients who trained with robotic support
Exercise capacity is measured by six-minute walking test in meters
Measured: 4 weeks
Mobility improves more in patients who trained with robotic support
Mobility is measured by timed-up-and-go tests in seconds
Measured: 8 weeks
Mobility improves more in patients who trained with robotic support
Mobility is measured by timed-up-and-go tests in seconds
Measured: 4 weeks
Balance improves more in patients who trained with robotic support
Balance is measured by berg balance tests via berg balance scale (0-56 points, the higher, the better).
Measured: 8 weeks
Balance improves more in patients who trained with robotic support
Balance is measured by berg balance tests via berg balance scale(0-56 points, the higher, the better).
Measured: 4 weeks
Exercise training improves quality of life
Quality of life is measured by Kansas City Cardiomyopathy Questionnaire
Measured: 8 weeks
Heart failure Progression: Ejection fractions
Change of echocardiographic findings: ejection fraction (in %)
Measured: 4 weeks
Heart failure Progression: Diameters
Change of echocardiographic findings: diameters (in mm)
Measured: 8 weeks
Heart failure Progression: valve regurgitations
Change of echocardiographic findings: regurgitations (grad I-V)
Measured: 8 weeks
Heart failure Progression: elevated filling pressures
Change of echocardiographic findings: end-diastolic pressure (elevated or normal)
Measured: 8 weeks
Heart failure Progression: volume status
Change of echocardiographic findings: vena cava diameter (in mm)
Measured: 8 weeks
Change in Heart failure biomarkers: NT-proBNP
Heart failure biomarkers: NT-proBNP
Measured: 8 weeks
Change in Heart failure biomarkers: hsTroponin
Heart failure biomarkers: hsTroponin
Measured: 8 weeks
Change in inflammatory biomarkers: hsCRP
Inflammatory biomarkers: NT-proBNP (in ng/mL)
Measured: 8 weeks
Change in inflammatory biomarkers: IL-6
Inflammatory biomarkers: IL-6
Measured: 8 weeks
Secondary outcomes (1)
Device acceptability
measured by a acceptability questionnaire (9 questions, Score 9 to 63, the higher, the better).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 Nov 2021
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, SystolicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich, Charite University, Berlin, Germany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278429
- Sponsor's protocol ID
- Myosuit Efficacy Trial
- Status last verified
- Apr 2024
- First submitted
- 16 Nov 2021
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-assisted Exercise Training in Heart Failure With Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT05278429
- Acronym / sponsor ID
- Myosuit Efficacy Trial
- Conditions
- Heart Failure, Systolic
- Keywords
- Exercise training, Robotic training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- German Heart InstituteUniversity, hospital or other
- Collaborators
- ETH Zurich, Charite University, Berlin, Germany
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myosuit arm | Active comparator | Device: Myosuit robotic devicePatients perform exercise training with the Myosuit |
| Control arm | Other | Device: Myosuit robotic devicePatients perform exercise training without the Myosuit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myosuit robotic deviceThe Myosuit is a partially soft, exoskeleton-type, wearable robot that supports the synergistic extension of the hip and knee joints. | Device | Control arm, Myosuit arm |
Primary outcome
Exercise capacity improves more in patients who trained with robotic support
Time frame: 8 weeks
Exercise capacity is measured by six-minute walking test in meters
Exercise capacity improves more in patients who trained with robotic support
Time frame: 4 weeks
Exercise capacity is measured by six-minute walking test in meters
Mobility improves more in patients who trained with robotic support
Time frame: 8 weeks
Mobility is measured by timed-up-and-go tests in seconds
Mobility improves more in patients who trained with robotic support
Time frame: 4 weeks
Mobility is measured by timed-up-and-go tests in seconds
Balance improves more in patients who trained with robotic support
Time frame: 8 weeks
Balance is measured by berg balance tests via berg balance scale (0-56 points, the higher, the better).
Balance improves more in patients who trained with robotic support
Time frame: 4 weeks
Balance is measured by berg balance tests via berg balance scale(0-56 points, the higher, the better).
Exercise training improves quality of life
Time frame: 8 weeks
Quality of life is measured by Kansas City Cardiomyopathy Questionnaire
Heart failure Progression: Ejection fractions
Time frame: 4 weeks
Change of echocardiographic findings: ejection fraction (in %)
Heart failure Progression: Diameters
Time frame: 8 weeks
Change of echocardiographic findings: diameters (in mm)
Heart failure Progression: valve regurgitations
Time frame: 8 weeks
Change of echocardiographic findings: regurgitations (grad I-V)
Heart failure Progression: elevated filling pressures
Time frame: 8 weeks
Change of echocardiographic findings: end-diastolic pressure (elevated or normal)
Heart failure Progression: volume status
Time frame: 8 weeks
Change of echocardiographic findings: vena cava diameter (in mm)
Change in Heart failure biomarkers: NT-proBNP
Time frame: 8 weeks
Heart failure biomarkers: NT-proBNP
Change in Heart failure biomarkers: hsTroponin
Time frame: 8 weeks
Heart failure biomarkers: hsTroponin
Change in inflammatory biomarkers: hsCRP
Time frame: 8 weeks
Inflammatory biomarkers: NT-proBNP (in ng/mL)
Change in inflammatory biomarkers: IL-6
Time frame: 8 weeks
Inflammatory biomarkers: IL-6
1 secondary outcome
Device acceptability
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myosuit robotic device in people with Heart Failure, Systolic, run by German Heart Institute at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabell A Just, MD (00493045932025, herzsport@dhzb.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity improves more in patients who trained with robotic support (time frame: 8 weeks). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024; AzTrials last refreshed its copy on 2 Nov 2026.