Interval Versus Continuous Training in LVAD Patients

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Training

• Registration Number: NCT05121077
• Lead Sponsor: University Hospital, Essen

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.

Study Timeline

• Study Start: 2021-08-23
• Study First Submitted: 2021-10-23
• Study First Submitted QC: 2021-11-15
• Study First Posted: 2021-11-16
• Primary Completion: 2022-09-18
• Status Verified: 2022-10
• Study Completion: 2022-10-01
• Last Update Submitted: 2022-10-05
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate continuous training	Training	Participants will continuously exercise at a workload between 50-60% of VO2peak on a bicycle ergometer.
Interval training	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Uniklinikum Essen; 🇩🇪 Essen, Germany