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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Daily physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 45 to 65 men time since cfLVAD implantation > 3 months and < 6 months low pulse pressure at rest, (no pulsatility) Exclusion Criteria: musculoskeletal comorbidities restricting exercise known diabetes mellitus Type 1 and 2 acute or chronic infections coronary heart disease before cfLVAD implantation no pulsatility with increasing exercise

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daily physical activity<br>Eligible subjects will be included in the feasibility study to conduct an individualized and structured training program with defined walking and cycling on a bicycle ergometer for 2 months. | Behavioral: Daily physical activity<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in brachial artery smooth muscle thickness | Unit: mm | At baseline and after 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in peak oxygen consumption | Unit: ml/min/kg | At baseline and after 2 months | 
| Change from baseline in pulse pressure during rest and exercise | Unit: mm/Hg | At baseline and after 2 months | 
| Change from baseline in daily physical activity | Unit: Steps per day assessed with a wearable activity device | At baseline, after week 3, week 6, and after 2 months | 
| Change from baseline in quality of life questionnaire (SF-36) | Unit: points | At baseline and after 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LVAD