Heart FailureNCT02146196
Robotic Assisted Rehabilitation for Heart Failure Patients and Patients After Cardiac Surgery
A study testing 4 weeks robotic assisted training with the Lokomat® and One week robotic assisted gait training with the Lokomat® in people with Heart Failure and Post Cardiac Surgery, run by University of Zurich at 1 site in Switzerland.
Trial summary
Robotic assisted gait therapy with the Lokomat® as a new method for rehabilitation in advanced heart failure and after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Post Cardiac Surgery
- What is being tested?
- 4 weeks robotic assisted training with the Lokomat® and One week robotic assisted gait training with the Lokomat®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2014to Dec 2014
- 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
- Heart failure patients:
- stable heart failure (over 3 months, NYHA 2, NYHA 3)
- Left ventricular ejection fraction less than 45% postoperative patients:
- possibility to walk at least 50m on the ground floor
Who cannot join
- weight >100kg
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8091
Felix Schoenrath, MD, 0041442559849, felix_schoenrath@gmx.de
Michael Stader, 00412553298, michael.stader@usz.ch
About this study
Official title: Roboter-unterstützte Kardiale Rehabilitation Herzinsuffzienter Patientinnen Und Patienten
Robotic assisted gait therapy with the Lokomat® as a new method for rehabilitation in advanced heart failure and after cardiac surgery.
Read the detailed description
Rehabilitation in heart failure medicine is limited due to many comorbidities and reduced exercise capacity in this patient group. In patients after cardiac surgery rehabilitation is sometimes difficult especially due to ICU- acquired weakness following a prolonged intensive care course. To tackle these problems and enable recovery and rehabilitation many of the conventional methods are lacking feasibility. During the next decades increasing numbers of older and more frail patients in the field of advanced heart failure are expected. To establish a new method for rehabilitation we use technology well established in other divisions of medicine. Robotic assisted gait therapy is well established in neurology in paraplegic and tetraplegic patients, patients after stroke and traumatic injured patients. Gait therapy is used to re-establish the normal course of motion. The Lokomat ® (Hocoma AG) is therefore used in over 25 countries worldwide. The combination of different training modes (interval training, endurance training and resistance training) is one of the advantages. The most important benefit is the possibility to extend or relieve the robotic assistance up to a point without support on the one hand and full support from the Lokomat ® on the other hand and relieve the patient partly or complete from his bodyweight. This enables the therapist to plan the most possible individual training almost independent from his exercise capacity for each patient. Up to now heart failure is a contraindication for training with the Lokomat ® and no trial was performed after cardiac surgery. Therefore a clinical trial is necessary to establish this method in the field of heart failure medicine and after cardiac surgery. In our prospective trial we investigate two points after a feasibility trial first, were healthy persons and patients with NYHA 1 or less are trained for safety reasons, to establish possible protocols and get familiar with the robotic assisted gait therapy. In the prospective trial we train patients with stable heart failure (NYHA 2 or NYHA 3) and a left ventricular ejection fraction less than 45% for 4 weeks with 3 trainings per week.
Timeframe for heart failure Patients: Screening day0; Baseline/Start of the training day0 +(0-5days); training period day0+ (0-5days) up to 4 Weeks, 28 days of training with the Lokomat®. Each week three training periods; End of Study Visit after 4 to 5 Weeks from baseline.
Timeframe for patients after cardiac surgery: Screening day0; baseline/start of the training day0 +(0-2days); training period one week with the Lokomat® with three training sessions; end of study visit after one week, telephone follow up twelve weeks after hospital discharge to evaluate possible deep sterna wound infection. Due to the character as a pilot trial, there are no statistical end points, but stress test (spiroergometry), blood sample (interleukin 6, CRP, BNP) , strength measurement of the Musc. quadriceps and a quality of life questionnaire (SF 36) are taken at baseline (day0) and after the 4 week training period at end of study visit. Patients after cardiac surgery are trained with another strategy. There the safety aspect is the most important in this pilot trial. Patients after cardiac surgery are trained with the Lokomat® during initial hospitalization for one week with three sessions. A six minute walk test and measurement of quadriceps peak force is done at at baseline/start of the training day0, expected at day 3 to 14 after surgery, and after one week of training at end of study visit day seven. A telephone follow up of this patients three months after hospital discharge is done for possible deep sternal wound infection.
Each training in the heart failure group should lasts 30-45minutes. The heart failure group should contain 5-6 patients. The training in the postcardiotomy group should last 10-40minutes depending on patients postoperative status. The postcardiotomy group should contain 10 patients. 20 patients receiving normal postoperative physiotherapy serve as a control group.
- Conditions
- Heart Failure, Post Cardiac Surgery
- Being tested
- 4 weeks robotic assisted training with the Lokomat®, One week robotic assisted gait training with the Lokomat®
- Keywords
- Heart failure, robotic assisted gait therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 weeks robotic assisted training with the Lokomat®Device
During a prespecified time period (4weeks) a three times weekly robotic assisted gait training during 30-45 minutes. Strength training, interval training and endurance training are possible.
One week robotic assisted gait training with the Lokomat®Device
During a prespecified time period (1week) a three times weekly robotic assisted gait training during 10-40 minutes. Strength training, interval training and endurance training are possible
| Study group | Role | What they receive |
|---|---|---|
| Heart failure, robotic assisted training | Experimental | 4 weeks robotic assisted training with the Lokomat® Receives: Device: 4 weeks robotic assisted training with the Lokomat® |
| Post cardiac surgery | Experimental | One week robotic assisted gait training with the Lokomat® Receives: Device: One week robotic assisted gait training with the Lokomat® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deep sternal wound infections
Occurence of deep sternal wound infections due to training, only in patients after cardiac surgery
Measured: 12 weeks after hospital discharge
Changes in VO2 (maximal oxygen uptak in ml/(kg*min))
Change in maximal oxygen uptake during spiroergometry due to training, only in heart failure patients
Measured: After four weeks robot-assisted training with the Lokomat®
Changes in BNP
Change in brain natriuretic peptide due to training, measured in mg/ml. Only in heart failure patients.
Measured: After four weeks robot-assisted training with the Lokomat®
Changes in strength measurement of the musculus quadriceps
isometric strength of the musculus quadriceps measured in kilopond
Measured: After four weeks robotic assisted training with the Lokomat®. In the postcardiotomy group after one week robot-assisted training
Changes in CRP (C- reactive protein)
Change in C- reactive protein, due to training, measured in mg/ml. Only in heart failure patients.
Measured: After four weeks robot-assisted training with the Lokomat®
Changes in IL 6 (interleukin 6)
Change in interleukin 6(measured in mg/ml), due to training. Only in heart failure patients.
Measured: After four weeks robot-assisted training with the Lokomat®
Changes in SF 36
Questionaire (SF 36- short form 36 of health survey) to assess changes in quality of life due to the training. Only in heart failure patients
Measured: After four weeks robot-assisted training with the Lokomat®
Changes in walking distance (in meters) in 6 minute walk test (MWT)
6 minute walk test to assess changes in walking distance after training period, only in patients after cardiac surgery
Measured: After one week robot-assisted training with the Lokomat®
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startFeb 2014
- Primary completionNov 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Volkmar Falk, MD, Study director, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146196
- Sponsor's protocol ID
- ZH_2011_0119
- Status last verified
- Oct 2014
- First submitted
- 11 May 2014
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schoenrath F, Markendorf S, Brauchlin AE, Frank M, Wilhelm MJ, Saleh L, Riener R, Schmied CM, Falk V. Robot-assisted training for heart failure patients - a small pilot study. Acta Cardiol. 2015 Dec;70(6):665-71. doi: 10.2143/AC.70.6.3120178.
PubMed 26717214Schoenrath F, Markendorf S, Brauchlin AE, Seifert B, Wilhelm MJ, Czerny M, Riener R, Falk V, Schmied CM. Robot-Assisted Training Early After Cardiac Surgery. J Card Surg. 2015 Jul;30(7):574-80. doi: 10.1111/jocs.12576. Epub 2015 May 22.
PubMed 25998717
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Roboter-unterstützte Kardiale Rehabilitation Herzinsuffzienter Patientinnen Und Patienten
- ClinicalTrials.gov ID
- NCT02146196
- Acronym / sponsor ID
- ZH_2011_0119
- Conditions
- Heart Failure, Post Cardiac Surgery
- Keywords
- Heart failure, robotic assisted gait therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 23 May 2014 (estimated)
- 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.
Robotic assisted gait therapy with the Lokomat® as a new method for rehabilitation in advanced heart failure and after cardiac surgery.
Detailed description
Rehabilitation in heart failure medicine is limited due to many comorbidities and reduced exercise capacity in this patient group. In patients after cardiac surgery rehabilitation is sometimes difficult especially due to ICU- acquired weakness following a prolonged intensive care course. To tackle these problems and enable recovery and rehabilitation many of the conventional methods are lacking feasibility. During the next decades increasing numbers of older and more frail patients in the field of advanced heart failure are expected. To establish a new method for rehabilitation we use technology well established in other divisions of medicine. Robotic assisted gait therapy is well established in neurology in paraplegic and tetraplegic patients, patients after stroke and traumatic injured patients. Gait therapy is used to re-establish the normal course of motion. The Lokomat ® (Hocoma AG) is therefore used in over 25 countries worldwide. The combination of different training modes (interval training, endurance training and resistance training) is one of the advantages. The most important benefit is the possibility to extend or relieve the robotic assistance up to a point without support on the one hand and full support from the Lokomat ® on the other hand and relieve the patient partly or complete from his bodyweight. This enables the therapist to plan the most possible individual training almost independent from his exercise capacity for each patient. Up to now heart failure is a contraindication for training with the Lokomat ® and no trial was performed after cardiac surgery. Therefore a clinical trial is necessary to establish this method in the field of heart failure medicine and after cardiac surgery. In our prospective trial we investigate two points after a feasibility trial first, were healthy persons and patients with NYHA 1 or less are trained for safety reasons, to establish possible protocols and get familiar with the robotic assisted gait therapy. In the prospective trial we train patients with stable heart failure (NYHA 2 or NYHA 3) and a left ventricular ejection fraction less than 45% for 4 weeks with 3 trainings per week.
Timeframe for heart failure Patients: Screening day0; Baseline/Start of the training day0 +(0-5days); training period day0+ (0-5days) up to 4 Weeks, 28 days of training with the Lokomat®. Each week three training periods; End of Study Visit after 4 to 5 Weeks from baseline.
Timeframe for patients after cardiac surgery: Screening day0; baseline/start of the training day0 +(0-2days); training period one week with the Lokomat® with three training sessions; end of study visit after one week, telephone follow up twelve weeks after hospital discharge to evaluate possible deep sterna wound infection. Due to the character as a pilot trial, there are no statistical end points, but stress test (spiroergometry), blood sample (interleukin 6, CRP, BNP) , strength measurement of the Musc. quadriceps and a quality of life questionnaire (SF 36) are taken at baseline (day0) and after the 4 week training period at end of study visit. Patients after cardiac surgery are trained with another strategy. There the safety aspect is the most important in this pilot trial. Patients after cardiac surgery are trained with the Lokomat® during initial hospitalization for one week with three sessions. A six minute walk test and measurement of quadriceps peak force is done at at baseline/start of the training day0, expected at day 3 to 14 after surgery, and after one week of training at end of study visit day seven. A telephone follow up of this patients three months after hospital discharge is done for possible deep sternal wound infection.
Each training in the heart failure group should lasts 30-45minutes. The heart failure group should contain 5-6 patients. The training in the postcardiotomy group should last 10-40minutes depending on patients postoperative status. The postcardiotomy group should contain 10 patients. 20 patients receiving normal postoperative physiotherapy serve as a control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart failure, robotic assisted training | Experimental | Device: 4 weeks robotic assisted training with the Lokomat®4 weeks robotic assisted training with the Lokomat® |
| Post cardiac surgery | Experimental | Device: One week robotic assisted gait training with the Lokomat®One week robotic assisted gait training with the Lokomat® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- stable heart failure (over 3 months, NYHA 2, NYHA 3)
- Left ventricular ejection fraction less than 45% postoperative patients:
- possibility to walk at least 50m on the ground floor
Key exclusion criteria (1 listed)
- weight >100kg
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 |
|---|---|---|
| 4 weeks robotic assisted training with the Lokomat®During a prespecified time period (4weeks) a three times weekly robotic assisted gait training during 30-45 minutes. Strength training, interval training and endurance training are possible. | Device | Heart failure, robotic assisted training |
| One week robotic assisted gait training with the Lokomat®During a prespecified time period (1week) a three times weekly robotic assisted gait training during 10-40 minutes. Strength training, interval training and endurance training are possible | Device | Post cardiac surgery |
Primary outcome
Deep sternal wound infections
Time frame: 12 weeks after hospital discharge
Occurence of deep sternal wound infections due to training, only in patients after cardiac surgery
Changes in VO2 (maximal oxygen uptak in ml/(kg*min))
Time frame: After four weeks robot-assisted training with the Lokomat®
Change in maximal oxygen uptake during spiroergometry due to training, only in heart failure patients
Changes in BNP
Time frame: After four weeks robot-assisted training with the Lokomat®
Change in brain natriuretic peptide due to training, measured in mg/ml. Only in heart failure patients.
Changes in strength measurement of the musculus quadriceps
Time frame: After four weeks robotic assisted training with the Lokomat®. In the postcardiotomy group after one week robot-assisted training
isometric strength of the musculus quadriceps measured in kilopond
Changes in CRP (C- reactive protein)
Time frame: After four weeks robot-assisted training with the Lokomat®
Change in C- reactive protein, due to training, measured in mg/ml. Only in heart failure patients.
Changes in IL 6 (interleukin 6)
Time frame: After four weeks robot-assisted training with the Lokomat®
Change in interleukin 6(measured in mg/ml), due to training. Only in heart failure patients.
Changes in SF 36
Time frame: After four weeks robot-assisted training with the Lokomat®
Questionaire (SF 36- short form 36 of health survey) to assess changes in quality of life due to the training. Only in heart failure patients
Changes in walking distance (in meters) in 6 minute walk test (MWT)
Time frame: After one week robot-assisted training with the Lokomat®
6 minute walk test to assess changes in walking distance after training period, only in patients after cardiac surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2014.
- Derived from this study: PubMed 26717214Schoenrath F, Markendorf S, Brauchlin AE, Frank M, Wilhelm MJ, Saleh L, Riener R, Schmied CM, Falk V. Robot-assisted training for heart failure patients - a small pilot study. Acta Cardiol. 2015 Dec;70(6):665-71. doi: 10.2143/AC.70.6.3120178.
- Derived from this study: PubMed 25998717Schoenrath F, Markendorf S, Brauchlin AE, Seifert B, Wilhelm MJ, Czerny M, Riener R, Falk V, Schmied CM. Robot-Assisted Training Early After Cardiac Surgery. J Card Surg. 2015 Jul;30(7):574-80. doi: 10.1111/jocs.12576. Epub 2015 May 22.
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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.
Volkmar Falk, MD study director
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4 weeks robotic assisted training with the Lokomat® and One week robotic assisted gait training with the Lokomat® in people with Heart Failure and Post Cardiac Surgery, run by University of Zurich at 1 site in Switzerland.
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 4 inclusion and 1 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 30 Oct 2014. 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 Switzerland. 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 Felix Schoenrath, MD (0041442553298, felix_schoenrath@gmx.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deep sternal wound infections (time frame: 12 weeks after hospital discharge). The study lists 8 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 NCT02146196, which also lists 2 linked publications.
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 30 Oct 2014.