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Interval Versus Continuous Training in LVAD Patients (TrainLVAD)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Training
Sponsored by
University Hospital, Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Exercise capacity, VO2peak, Interval training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age>18 years
  • clinically stable LVAD patients with terminal heart failure
  • written informed consent
  • the mental and physical ability to exercise

Exclusion Criteria:

  • established contraindications for exercise testing
  • systemic blood stream infection

Sites / Locations

  • Uniklinikum Essen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Moderate continuous training

Interval training

Arm Description

Participants will continuously exercise at a workload between 50-60% of VO2peak on a bicycle ergometer.

Participants will exercise at a varying workload between 50-60% of VO2peak during recovery and 80-90% of VO2peak during bouts of interval training on a bicycle ergometer.

Outcomes

Primary Outcome Measures

Improvement of peak oxygen uptake (VO2peak) in cardiopulmonary exercise testing (CPET) [ml/kg/min]
Improvement of VO2peak in CPET after a training period of 6 weeks. CPET will be performed before (t0) and after (t1) the training period. A significant improvement from t0 to t1 is considered to be an increase of at least 2,5ml/kg/min

Secondary Outcome Measures

Improvement in quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Improvement in quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score. Points range from 0 to 100 in each of four domains. The total score is the average of all domains, with higher values depicting better quality of life.

Full Information

First Posted
October 23, 2021
Last Updated
October 5, 2022
Sponsor
University Hospital, Essen
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1. Study Identification

Unique Protocol Identification Number
NCT05121077
Brief Title
Interval Versus Continuous Training in LVAD Patients
Acronym
TrainLVAD
Official Title
A Prospective, Comparative Analysis of Moderate-continuous (MCT) and Interval Training (IT) in LVAD (Left Ventricular Assist Device) Patients With Terminal Heart Failure: Train the LVAD Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
September 18, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Essen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Patients with a left ventricular assist device (LVAD) will be randomized to either a moderate continuous (MCT, 50-60% of VO2peak) or interval training (IT, 80-90% of VO2peak) group for 6 weeks with 3 sessions per week, lasting for 20 minutes. An additional 10 minutes of resistance training will be performed in each group. Improvement of VO2peak and quality of life (KCCQ score) between the groups will be assessed.
Detailed Description
In- and out-patients with left ventricular assist device (LVAD) will be recruited to participate. On consent to participate, patients will be randomized to either moderate continuous (MCT) or interval (IT) training. An initial cardiopulmonary exercise test (CPET) will be performed to assess exercise intensity levels using a ramp protocol. Baseline quality of life (KCCQ score), echocardiographic and LVAD parameters, lab works, including NTproBNP, a 6min walk distance (6 MWD) will be assessed. Patients will then receive 6 weeks of supervised training in our facility (3x/week, 30min each). Following these sessions CPET, lab works, KCCQ assessment, 6 MWD, and echocardiography will be performed to assess improvement of exercise capacity. Patients in the MCT group will receive 20min of moderate, continuous bicycle training at an intensity of 50-60% of VO2peak, the IT group will increase exercise density by increasing the duration of intense bouts (80-90% of VO2peak) over the weeks. All groups will receive an additional 10 minutes of resistance training (total exercise time 30 minutes in both groups). Improvement of VO2peak and quality of life (KCCQ score) between the groups will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Exercise capacity, VO2peak, Interval training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to either the MCT or IT training group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate continuous training
Arm Type
Experimental
Arm Description
Participants will continuously exercise at a workload between 50-60% of VO2peak on a bicycle ergometer.
Arm Title
Interval training
Arm Type
Experimental
Arm Description
Participants will exercise at a varying workload between 50-60% of VO2peak during recovery and 80-90% of VO2peak during bouts of interval training on a bicycle ergometer.
Intervention Type
Other
Intervention Name(s)
Training
Intervention Description
2 types of training intervention will be applied in terminal heart failure patients supported with a left ventricular assist device.
Primary Outcome Measure Information:
Title
Improvement of peak oxygen uptake (VO2peak) in cardiopulmonary exercise testing (CPET) [ml/kg/min]
Description
Improvement of VO2peak in CPET after a training period of 6 weeks. CPET will be performed before (t0) and after (t1) the training period. A significant improvement from t0 to t1 is considered to be an increase of at least 2,5ml/kg/min
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Improvement in quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
Improvement in quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score. Points range from 0 to 100 in each of four domains. The total score is the average of all domains, with higher values depicting better quality of life.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age>18 years clinically stable LVAD patients with terminal heart failure written informed consent the mental and physical ability to exercise Exclusion Criteria: established contraindications for exercise testing systemic blood stream infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Lüdike, Prof.
Organizational Affiliation
Westdeutsches Herz- und Gefäßzentrum Essen, Klinik für Kardiologie und Angiologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uniklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual data can be made available by the principal investigator on reasonable request.

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Interval Versus Continuous Training in LVAD Patients

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