TrainLVAD: Interval Versus Continuous Training in LVAD Patients

• Sponsor: University Hospital, Essen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05121077
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15.3
• Patients Per Site Per Month: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Other: Training	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients will be randomized to either the MCT or IT training groupPatients will be randomized to either the MCT or IT training group
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 23, 2021
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Moderate continuous training Participants will continuously exercise at a workload between 50-60% of VO2peak on a bicycle ergometer.	Other: Training; 2 types of training intervention will be applied in terminal heart failure patients supported with a left ventricular assist device.
Experimental: Interval training 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.	Other: Training; 2 types of training intervention will be applied in terminal heart failure patients supported with a left ventricular assist device.

Outcome Measures

Primary Outcome Measures

1. Improvement of peak oxygen uptake (VO2peak) in cardiopulmonary exercise testing (CPET) [ml/kg/min] [6 weeks]

   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

1. Improvement in quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [6 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uniklinikum Essen	Essen		Germany	45147

Sponsors and Collaborators

• University Hospital, Essen

Investigators

• Principal Investigator: Peter Lüdike, Prof., Westdeutsches Herz- und Gefäßzentrum Essen, Klinik für Kardiologie und Angiologie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter Lüdike, Prof., University Hospital, Essen
• ClinicalTrials.gov Identifier: NCT05121077
• Other Study ID Numbers: 21-10169-BO
• First Posted: Nov 16, 2021
• Last Update Posted: May 17, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peter Lüdike, Prof., University Hospital, Essen: Exercise capacity; VO2peak; Interval training
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of May 17, 2022