Skip to main content
OpenTrials
Completed

NCT Number: NCT02304965

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

45 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Daily physical activity

Behavioral

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.

Primary outcomes

  1. Change from baseline in brachial artery smooth muscle thickness

    Time frame: At baseline and after 2 months

    Unit: mm

Secondary outcomes

  1. Change from baseline in peak oxygen consumption

    Time frame: At baseline and after 2 months

    Unit: ml/min/kg

  2. Change from baseline in pulse pressure during rest and exercise

    Time frame: At baseline and after 2 months

    Unit: mm/Hg

  3. Change from baseline in daily physical activity

    Time frame: At baseline, after week 3, week 6, and after 2 months

    Unit: Steps per day assessed with a wearable activity device

  4. Change from baseline in quality of life questionnaire (SF-36)

    Time frame: At baseline and after 2 months

    Unit: points

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 2, 2014
Registry last updated
Sep 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.