Daily Physical Activity at Pulse Pressure Above an Individual Threshold in Patients With Continuous Flow Left Ventricular Assist Devices - a Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hannover Medical School
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- Change from baseline in brachial artery smooth muscle thickness
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age 45 to 65
- •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
Outcomes
Primary Outcomes
Change from baseline in brachial artery smooth muscle thickness
Time Frame: At baseline and after 2 months
Unit: mm
Secondary Outcomes
- Change from baseline in peak oxygen consumption(At baseline and after 2 months)
- Change from baseline in pulse pressure during rest and exercise(At baseline and after 2 months)
- Change from baseline in daily physical activity(At baseline, after week 3, week 6, and after 2 months)
- Change from baseline in quality of life questionnaire (SF-36)(At baseline and after 2 months)