Heart FailureNCT03984162
Influence of Individualized Training on Cardiopulmonary Exercise Capacity in LVAD Patients
An observational study of Heart Failure, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
Trial summary
The aim of this study is to examine the influence of an individualized, spiroergometry- guided training on cardiopulmonary fitness in patients with a left ventricular assist device (LVAD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jun 2019to 31 Dec 2022
- Phase
- Observational
- 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
- Adult, Older adult
Study population: - Patients with a first implanted left ventricular assist device (LVAD)
Who may be able to join
- new implanted LVAD
- current treatment in Hospital
- hemodynamically stable patients without i.v. ionotropic Treatment
- at hand echocardiogram
- at hand spirometry
- spiroergometry including blood gas analysis.
Who cannot join
- serious psychologic/ psychiatric disorders
- breastfeeding/ pregnancy
- serious neurologic disorders
- serious comorbidities that would compromise patient compliance
- missing written informed consent
- persistent inotropic therapy
- acute or enduring infections.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, North Rhine-Westphalia, 32545
About this study
Official title: Influence of Individualized, Spiroergometry Guided, Structural Training on Cardiopulmonary Exercise Capacity in Patients With a Left Ventricular Assist Device
The aim of this study is to examine the influence of an individualized, spiroergometry- guided training on cardiopulmonary fitness in patients with a left ventricular assist device (LVAD). Secondary endpoints are to establish an individualized but standardized and clinically safe training protocol for patients with LVAD implanted. The investigators aim to include sixty patients with first implanted LVAD to be included in this study over a term of 24 months. All study participants will perform cardiopulmonary exercise testing (CPET) at baseline before randomization and at the end of the study. Randomization into a control group and a training group will be performed subsequently. The control group will receive standard physiotherapeutic treatment as usual, including respiratory supportive therapy, mobilization, stability and coordination training. The training group will additionally receive five individualized training sessions on ergometer per week. Three sessions will consist of interval training; the other two sessions will consist of endurance training. The training group will further perform CPET every two weeks in order to adjust their individual training protocol.
Read the detailed description
b.) Current European guidelines for prevention of cardiovascular disease recommend regular training for patients suffering from any cardiovascular disease. Studies have shown that regular training results in an improvement of cardiopulmonary exercise capacity. Objective parameters such as peak VO2 and VE/ VCO2 slope can be positively influenced by training in patients with heart failure. Only few studies suggest a beneficial impact on exercise capacity in patients with an implanted ventricular assist device (LVAD), but literature on this topic is scarce. So far there are no recommendations for a standardized exercise protocol for LVAD.
The aim of this prospective monocentric study is to examine the influence of an individualized, spiroergometry- guided training protocol on cardiopulmonary fitness in patients with an implanted LVAD. Secondary endpoints are to establish an individualized but standardized and clinically safe training protocol for patients with implanted LVAD.
The investigators goal is to include sixty patients with first implanted LVAD in this study over a term of 24 months. After providing written informed consent, randomization into a control group and into a training group will be conducted. All study participants will perform cardiopulmonary exercise testing (CPET) initially before randomization and at the end of the study. The control group will receive the established recommended standard physiotherapeutic treatment, including respiratory supportive therapy, chest muscle mobilization, coordination and stability training as well as walking exercise units. The training group will additionally undergo five spiroergometry- guided training sessions on ergometer per week. Three training sessions will consist of interval training; the other two sessions will consist of endurance training. Interval training hereby consists of training unit of 30 seconds at VO2 peak (maximal oxygen uptake) followed by 60 seconds below the anaerobic threshold (VT1). Endurance training units will consist of training below VT1. Criteria to stop exercise include patient exertion (Borg scale > 14), reduction in LVAD pump flow, pump speed or pump power. Both groups will perform CPET and 6 minute walk test (6 MWT) at study initiation and at study end. The training group will perform CPET including blood gas analysis every two weeks in order to adjust their individual training protocol.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in constant work rate exercise time (cwret) at 75% of patients' peak workrate.
Patients undergo a ramp exercise test up to maximal tolerance. A second test is performed at constant workrate which equals 75% of the achieved maximal workrate during the ramp test.
Measured: 24 months
Secondary outcomes (3)
Change in VO2 Peak (ml/min/kg) after training
A ramp test will be performed at baseline and at the end of the training program. Changes in weight adapted values (ml/min/kg) will be assessed.
Measured: 24 months
Change in VE/VCO2 slope after training
A ramp test will be performed at baseline and at the end of the training program. Changes in the Ratio of Minute Ventilation vs. carbon dioxide Output will be assessed
Measured: 24 months
Safety of the structured training program
All adverse and serious Events will be recorded in the training and in the Control Group. Comparison between Groups will be performed.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start15 Jun 2019
- Primary completion31 Oct 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984162
- Sponsor's protocol ID
- HDZ_KA_016_LKW
- Status last verified
- Oct 2023
- First submitted
- 11 Mar 2019
- Last updated
- 10 Jan 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 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Individualized, Spiroergometry Guided, Structural Training on Cardiopulmonary Exercise Capacity in Patients With a Left Ventricular Assist Device
- ClinicalTrials.gov ID
- NCT03984162
- Acronym / sponsor ID
- HDZ_KA_016_LKW
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Heart and Diabetes Center North-Rhine WestfaliaUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 12 Jun 2019 (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.
The aim of this study is to examine the influence of an individualized, spiroergometry- guided training on cardiopulmonary fitness in patients with a left ventricular assist device (LVAD). Secondary endpoints are to establish an individualized but standardized and clinically safe training protocol for patients with LVAD implanted. The investigators aim to include sixty patients with first implanted LVAD to be included in this study over a term of 24 months. All study participants will perform cardiopulmonary exercise testing (CPET) at baseline before randomization and at the end of the study. Randomization into a control group and a training group will be performed subsequently. The control group will receive standard physiotherapeutic treatment as usual, including respiratory supportive therapy, mobilization, stability and coordination training. The training group will additionally receive five individualized training sessions on ergometer per week. Three sessions will consist of interval training; the other two sessions will consist of endurance training. The training group will further perform CPET every two weeks in order to adjust their individual training protocol.
Detailed description
b.) Current European guidelines for prevention of cardiovascular disease recommend regular training for patients suffering from any cardiovascular disease. Studies have shown that regular training results in an improvement of cardiopulmonary exercise capacity. Objective parameters such as peak VO2 and VE/ VCO2 slope can be positively influenced by training in patients with heart failure. Only few studies suggest a beneficial impact on exercise capacity in patients with an implanted ventricular assist device (LVAD), but literature on this topic is scarce. So far there are no recommendations for a standardized exercise protocol for LVAD.
The aim of this prospective monocentric study is to examine the influence of an individualized, spiroergometry- guided training protocol on cardiopulmonary fitness in patients with an implanted LVAD. Secondary endpoints are to establish an individualized but standardized and clinically safe training protocol for patients with implanted LVAD.
The investigators goal is to include sixty patients with first implanted LVAD in this study over a term of 24 months. After providing written informed consent, randomization into a control group and into a training group will be conducted. All study participants will perform cardiopulmonary exercise testing (CPET) initially before randomization and at the end of the study. The control group will receive the established recommended standard physiotherapeutic treatment, including respiratory supportive therapy, chest muscle mobilization, coordination and stability training as well as walking exercise units. The training group will additionally undergo five spiroergometry- guided training sessions on ergometer per week. Three training sessions will consist of interval training; the other two sessions will consist of endurance training. Interval training hereby consists of training unit of 30 seconds at VO2 peak (maximal oxygen uptake) followed by 60 seconds below the anaerobic threshold (VT1). Endurance training units will consist of training below VT1. Criteria to stop exercise include patient exertion (Borg scale > 14), reduction in LVAD pump flow, pump speed or pump power. Both groups will perform CPET and 6 minute walk test (6 MWT) at study initiation and at study end. The training group will perform CPET including blood gas analysis every two weeks in order to adjust their individual training protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- - Patients with a first implanted left ventricular assist device (LVAD)
Key inclusion criteria (6 listed)
- new implanted LVAD
- current treatment in Hospital
- hemodynamically stable patients without i.v. ionotropic Treatment
- at hand echocardiogram
- at hand spirometry
Key exclusion criteria (7 listed)
- serious psychologic/ psychiatric disorders
- breastfeeding/ pregnancy
- serious neurologic disorders
- serious comorbidities that would compromise patient compliance
- missing written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in constant work rate exercise time (cwret) at 75% of patients' peak workrate.
Time frame: 24 months
Patients undergo a ramp exercise test up to maximal tolerance. A second test is performed at constant workrate which equals 75% of the achieved maximal workrate during the ramp test.
3 secondary outcomes
Change in VO2 Peak (ml/min/kg) after training
Time frame: 24 months
Change in VE/VCO2 slope after training
Time frame: 24 months
Safety of the structured training program
Time frame: 24 months
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 10 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Heart and Diabetes Center North-Rhine Westfalia 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 7 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 10 Jan 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?
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?
Change in constant work rate exercise time (cwret) at 75% of patients' peak workrate. (time frame: 24 months). 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 10 Jan 2024.