Clinical trial NCT02304965: Activity at Pulse Pressure Above an Individual Threshold in Patients With LVAD
Official title: Daily Physical Activity at Pulse Pressure Above an Individual Threshold in Patients With Continuous Flow Left Ventricular Assist Devices - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: LVAD
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 7
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in brachial artery smooth muscle thickness
timeFrame: At baseline and after 2 months
Secondary outcomes:
measure: Change from baseline in peak oxygen consumption
timeFrame: At baseline and after 2 months
measure: Change from baseline in pulse pressure during rest and exercise
timeFrame: At baseline and after 2 months
measure: Change from baseline in daily physical activity
timeFrame: At baseline, after week 3, week 6, and after 2 months
measure: Change from baseline in quality of life questionnaire (SF-36)
timeFrame: At baseline and after 2 months
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
state: Lower Saxony
Study officials:
affiliation: Hannover Medical School
name: Sven Haufe, Dr.
role: PRINCIPAL_INVESTIGATOR
References: