Heart Failure
Conditions
Keywords
LVAD
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.
Interventions
BEHAVIORALDaily 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.
Sponsors
Hannover Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in brachial artery smooth muscle thickness | At baseline and after 2 months | Unit: mm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in peak oxygen consumption | At baseline and after 2 months | Unit: ml/min/kg |
| Change from baseline in pulse pressure during rest and exercise | At baseline and after 2 months | Unit: mm/Hg |
| Change from baseline in daily physical activity | At baseline, after week 3, week 6, and after 2 months | Unit: Steps per day assessed with a wearable activity device |
| Change from baseline in quality of life questionnaire (SF-36) | At baseline and after 2 months | Unit: points |
Countries
Germany
Outcome results
None listed