NCT02304965

Activity at Pulse Pressure Above an Individual Threshold in Patients With LVAD

Daily Physical Activity at Pulse Pressure Above an Individual Threshold in Patients With Continuous Flow Left Ventricular Assist Devices - a Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: Male
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Pilot study in patients with continuous flow left ventricular assist device (cfLVAD) to proof the feasibility of a specific individual training at home aimed to increase pulse pressure above a predefined threshold which might attenuate the loss of arterial wall thickness. Hypothesis: Increasing daily physical activity near to normal (\> 10.000 steps per day) with a pre-defined level of pulse pressure (intensity) is a realizable and feasible approach to investigate changes in arterial wall thickness and cardio-respiratory capacity in cfLVAD patients.

Detailed description

The investigators will study 3 cfLVAD patients with low pulse pressure during work package 1 using two different exercises, treadmill and bicycle. Walking and cycling present the most commonly used physical activities which are applicable to most individuals on a daily basis. The investigators aim to demonstrate that individual changes of pulse pressure during these types of exercise can be assessed in cfLVAD patients. In a feasibility study (work package 2) the investigator will enroll 6 cfLVAD patients to perform home-based physical activity programs including walking a defined number of steps per day with a predefined speed and cycling with a predefined power \[watt\] on a bicycle ergometer. The performance of the patients will be monitored over seven days using a wearable activity device.

Conditions

• Heart Failure

Interventions

Type	Name	Description
BEHAVIORAL	Daily physical activity	A combination of walking (\> 10.000 steps per day) and cycling on a stationary bicycle at home at an individual intensity. For the activity walking patients need to walk at a certain speed (e.g. 3 km/h) in order to be in the range of pulsatility as obtained from their pre-training treadmill test. For cycling a defined power in watt and duration will be given to each patient as defined from the pre-training cycling test.

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-06-01
• Completion: 2015-09-01
• First posted: 2014-12-02
• Last updated: 2015-09-03

Locations

1 site across 1 country: Germany