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

September 2, 2015 updated by: Hannover Medical School

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Lower Saxony
      • Hannover, Lower Saxony, Germany, 30625
        • Hannover Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Daily physical activity
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
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in peak oxygen consumption
Time Frame: At baseline and after 2 months
Unit: ml/min/kg
At baseline and after 2 months
Change from baseline in pulse pressure during rest and exercise
Time Frame: At baseline and after 2 months
Unit: mm/Hg
At baseline and after 2 months
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
At baseline, after week 3, week 6, and after 2 months
Change from baseline in quality of life questionnaire (SF-36)
Time Frame: At baseline and after 2 months
Unit: points
At baseline and after 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Investigators

  • Principal Investigator: Sven Haufe, Dr., Hannover Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

November 21, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Estimate)

September 3, 2015

Last Update Submitted That Met QC Criteria

September 2, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-B03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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