Heart Failure, SystolicNCT04839133
Robotic-assisted Exercise Training in Heart Failure
A study testing MyoSuitFeasibility in people with Heart Failure, Systolic and Pulmonary Disease, run by German Heart Institute at 2 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Systolic, Pulmonary Disease
- What is being tested?
- MyoSuitFeasibility
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesGermany
- Study dates
- 31 Mar 2021to 31 Jul 2021
- 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% 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
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.
- Height <150 cm, >195 cm
Show all 10Show fewer
- 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
2 sites in 1 country.
Germany2 sites
German Heart Center
Berlin, 13353
German Heart Institute
Berlin, 13353
About this study
Official title: Feasibility of Robotic Assisted Exercise Training in Patients With Advanced Heart Failure or Advanced Pulmonary Diseases
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.
Read more
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.
- Conditions
- Heart Failure, Systolic, Pulmonary Disease
- Being tested
- MyoSuitFeasibility
- Keywords
- Exercise training, Robotic training, Exosuit training
- Medical subject headings
- Heart Failure, Systolic, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoSuitFeasibilityDevice
Participants will absolve feasibility tests with and without wearing a MyoSuit.
| Study group | Role | What they receive |
|---|---|---|
| Feasibility study group | Other | Not described Receives: Device: MyoSuitFeasibility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Falls - Safety of the MyoSuit
Patients with advanced heart or pulmonary failure will perform 6-minute walking tests and activities of daily life both with and without wearing a MyoSuit. Outcome is measured by documenting number of falls.
Measured: 1 hour
Incidence of Treatment-Emergent Adverse Events - Safety of the MyoSuit
Patients with advanced heart or pulmonary failure will perform 6-minute walking tests and activities of daily life both with and without wearing a MyoSuit. Outcome is measured by documenting adverse events.
Measured: 1 hour
Exercise can be performed when wearing a MyoSuit - Feasibility and Tolerability of walking test, activities of daily life, rehabilitation exercise group.
Patients with advanced heart or pulmonary failure will perform a 6 minute walking test, activities of daily life and a cardiac rehabilitation exercise unit. Outcome is measured dichotomously (yes/no) according to its feasibility.
Measured: 1 hour
Necessity of assistance in exercising when wearing a MyoSuit - Feasibility and Tolerability
Patients with advanced heart or pulmonary failure will perform a 6 minute walking test, activities of daily lif and a cardiac rehabilitation exercise unit. Outcome is measured according to a scale of assistance needed (1=no assistance, 2=little assistance, 3=much assistance, 4=not possible). 1 is minimum, 4 is maximum. The higher the score, the worse the outcome.
Measured: 1 hour
MyoSuit assistance leads to changes in walking distance in patients with advanced heart or pulmonary failure assessed by 6-minute walking test.
Change of 6minute walk distance in meters will be assessed with and without MyoSuit in every participant.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start31 Mar 2021
- Primary completion30 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839133
- Sponsor's protocol ID
- MyoSuit Feasibility Trial
- Status last verified
- Nov 2021
- First submitted
- 29 Mar 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Just IA, Fries D, Loewe S, Falk V, Cesarovic N, Edelmann F, Feuerstein A, Haufe FL, Xiloyannis M, Riener R, Schoenrath F. Movement therapy in advanced heart failure assisted by a lightweight wearable robot: a feasibility pilot study. ESC Heart Fail. 2022 Jun;9(3):1643-1650. doi: 10.1002/ehf2.13903. Epub 2022 Mar 23.
PubMed 35320878
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Robotic Assisted Exercise Training in Patients With Advanced Heart Failure or Advanced Pulmonary Diseases
- ClinicalTrials.gov ID
- NCT04839133
- Acronym / sponsor ID
- MyoSuit Feasibility Trial
- Conditions
- Heart Failure, Systolic, Pulmonary Disease
- Keywords
- Exercise training, Robotic training, Exosuit training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- German Heart InstituteUniversity, hospital or other
- Collaborators
- ETH Zurich
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 9 Apr 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasibility study group | Other | Device: MyoSuitFeasibility |
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% 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
Key exclusion criteria (10 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
- BMI > 35 kg/m², waist size > 135 cm.
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 |
|---|---|---|
| MyoSuitFeasibilityParticipants will absolve feasibility tests with and without wearing a MyoSuit. | Device | Feasibility study group |
Primary outcome
Incidence of Treatment-Emergent Falls - Safety of the MyoSuit
Time frame: 1 hour
Patients with advanced heart or pulmonary failure will perform 6-minute walking tests and activities of daily life both with and without wearing a MyoSuit. Outcome is measured by documenting number of falls.
Incidence of Treatment-Emergent Adverse Events - Safety of the MyoSuit
Time frame: 1 hour
Patients with advanced heart or pulmonary failure will perform 6-minute walking tests and activities of daily life both with and without wearing a MyoSuit. Outcome is measured by documenting adverse events.
Exercise can be performed when wearing a MyoSuit - Feasibility and Tolerability of walking test, activities of daily life, rehabilitation exercise group.
Time frame: 1 hour
Patients with advanced heart or pulmonary failure will perform a 6 minute walking test, activities of daily life and a cardiac rehabilitation exercise unit. Outcome is measured dichotomously (yes/no) according to its feasibility.
Necessity of assistance in exercising when wearing a MyoSuit - Feasibility and Tolerability
Time frame: 1 hour
Patients with advanced heart or pulmonary failure will perform a 6 minute walking test, activities of daily lif and a cardiac rehabilitation exercise unit. Outcome is measured according to a scale of assistance needed (1=no assistance, 2=little assistance, 3=much assistance, 4=not possible). 1 is minimum, 4 is maximum. The higher the score, the worse the outcome.
MyoSuit assistance leads to changes in walking distance in patients with advanced heart or pulmonary failure assessed by 6-minute walking test.
Time frame: 30 minutes
Change of 6minute walk distance in meters will be assessed with and without MyoSuit in every participant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Derived from this study: PubMed 35320878Just IA, Fries D, Loewe S, Falk V, Cesarovic N, Edelmann F, Feuerstein A, Haufe FL, Xiloyannis M, Riener R, Schoenrath F. Movement therapy in advanced heart failure assisted by a lightweight wearable robot: a feasibility pilot study. ESC Heart Fail. 2022 Jun;9(3):1643-1650. doi: 10.1002/ehf2.13903. Epub 2022 Mar 23.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyoSuitFeasibility in people with Heart Failure, Systolic and Pulmonary Disease, run by German Heart Institute at 2 sites 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 10 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: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Falls - Safety of the MyoSuit (time frame: 1 hour). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04839133, which also lists 1 linked publication.
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 24 Nov 2021.