Interval Versus Continuous Training in LVAD Patients

NCT05121077 | Completed

• 1 other identifier: 21-10169-BO
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Exercise capacity; VO2peak; Interval training

Outcome Measures

Primary Outcomes (1)

• 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

  6 weeks

Secondary Outcomes (1)

• Improvement in quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

  6 weeks

Study Arms (2)

Moderate continuous training

EXPERIMENTAL

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

Other: Training

Interval training

EXPERIMENTAL

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

Interventions

Training OTHER

2 types of training intervention will be applied in terminal heart failure patients supported with a left ventricular assist device.

Interval training; Moderate continuous training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• established contraindications for exercise testing
• systemic blood stream infection

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (1)

Uniklinikum Essen

Essen, 45147, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Peter Lüdike, Prof.

  Westdeutsches Herz- und Gefäßzentrum Essen, Klinik für Kardiologie und Angiologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: Patients will be randomized to either the MCT or IT training group

Study Record Dates

• First Submitted: October 23, 2021
• First Posted: November 16, 2021
• Study Start: August 23, 2021
• Primary Completion: September 18, 2022
• Study Completion: October 1, 2022
• Last Updated: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)