Influence of Individualized Training on Cardiopulmonary Exercise Capacity in LVAD Patients

NCT03984162 | Completed

• 1 other identifier: HDZ_KA_016_LKW
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (3)

• Change in VO2 Peak (ml/min/kg) after training

  24 months

• Change in VE/VCO2 slope after training

  24 months

• Safety of the structured training program

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

\- Patients with a first implanted left ventricular assist device (LVAD)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heart and Diabetes Center North-Rhine Westfalia: lead

Study Sites (1)

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: June 12, 2019
• Study Start: June 15, 2019
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 10, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)