Activity at Pulse Pressure Above an Individual Threshold in Patients With LVAD
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Daily physical activity
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring LVAD
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
Sites / Locations
- Hannover Medical School
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Daily physical activity
Arm Description
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.
Outcomes
Primary Outcome Measures
Change from baseline in brachial artery smooth muscle thickness
Unit: mm
Secondary Outcome Measures
Change from baseline in peak oxygen consumption
Unit: ml/min/kg
Change from baseline in pulse pressure during rest and exercise
Unit: mm/Hg
Change from baseline in daily physical activity
Unit: Steps per day assessed with a wearable activity device
Change from baseline in quality of life questionnaire (SF-36)
Unit: points
Full Information
NCT ID
NCT02304965
First Posted
November 21, 2014
Last Updated
September 2, 2015
Sponsor
Hannover Medical School
1. Study Identification
Unique Protocol Identification Number
NCT02304965
Brief Title
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
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hannover Medical School
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
LVAD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daily physical activity
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Daily physical activity
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline in brachial artery smooth muscle thickness
Description
Unit: mm
Time Frame
At baseline and after 2 months
Secondary Outcome Measure Information:
Title
Change from baseline in peak oxygen consumption
Description
Unit: ml/min/kg
Time Frame
At baseline and after 2 months
Title
Change from baseline in pulse pressure during rest and exercise
Description
Unit: mm/Hg
Time Frame
At baseline and after 2 months
Title
Change from baseline in daily physical activity
Description
Unit: Steps per day assessed with a wearable activity device
Time Frame
At baseline, after week 3, week 6, and after 2 months
Title
Change from baseline in quality of life questionnaire (SF-36)
Description
Unit: points
Time Frame
At baseline and after 2 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Haufe, Dr.
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hannover Medical School
City
Hannover
State/Province
Lower Saxony
ZIP/Postal Code
30625
Country
Germany
12. IPD Sharing Statement
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Activity at Pulse Pressure Above an Individual Threshold in Patients With LVAD
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