Venous Function in Cardiovascular Disease Patients
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
interval training day 1
Moderate exercise day 2
Control day 3
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Coronary artery bypass, Exercise therapy, Revascularization (PCI)
Eligibility Criteria
Inclusion Criteria:
- myocardial infraction (MI)
- revascularization (PCI)
- coronary artery bypass graft surgery (CABG)
Exclusion Criteria:
- unstable angina pectoris
- uncontrolled hypertension
- orthopedic and/or neurological limitations
- participation in other studies
- MI (closer than 4 weeks)
Sites / Locations
- Institutt for Sirkulasjon og Bildetechnikk, NTNU
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
interval training
moderate exercise
control
Arm Description
4 x 4 minutes exercise at 90 - 95 % of peak heart rate separated with 3 minutes at 70 % of peaks heart rate
moderate continuous exercise at 70 % of peak heart rate on venous function.
routine measurements, no exercise
Outcomes
Primary Outcome Measures
Venous Compliance change
Measured by echocardiography
Secondary Outcome Measures
Full Information
NCT ID
NCT01474408
First Posted
November 4, 2011
Last Updated
February 13, 2017
Sponsor
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT01474408
Brief Title
Venous Function in Cardiovascular Disease Patients
Official Title
Venous Function in Cardiovascular Disease Patients; The Neglected Part of Circulatory Regulation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary aim is to determine the acute effect of two different training interventions on venous plasticity in patients with myocardial infarction (MI), revascularization or coronary artery graft surgery compared to age-matched healthy subjects.
Detailed Description
Compare the effect of 4 x 4 minutes at 90 - 95 % of peak heart rate separated with 3 minutes at 70 % of peaks heart rate and moderate continuous exercise at 70 % of peak heart rate on venous function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Coronary artery bypass, Exercise therapy, Revascularization (PCI)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
interval training
Arm Type
Experimental
Arm Description
4 x 4 minutes exercise at 90 - 95 % of peak heart rate separated with 3 minutes at 70 % of peaks heart rate
Arm Title
moderate exercise
Arm Type
Active Comparator
Arm Description
moderate continuous exercise at 70 % of peak heart rate on venous function.
Arm Title
control
Arm Type
Other
Arm Description
routine measurements, no exercise
Intervention Type
Behavioral
Intervention Name(s)
interval training day 1
Other Intervention Name(s)
aerobic interval training
Intervention Type
Behavioral
Intervention Name(s)
Moderate exercise day 2
Intervention Type
Behavioral
Intervention Name(s)
Control day 3
Primary Outcome Measure Information:
Title
Venous Compliance change
Description
Measured by echocardiography
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
myocardial infraction (MI)
revascularization (PCI)
coronary artery bypass graft surgery (CABG)
Exclusion Criteria:
unstable angina pectoris
uncontrolled hypertension
orthopedic and/or neurological limitations
participation in other studies
MI (closer than 4 weeks)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrik Wisløff, prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Institutt for Sirkulasjon og Bildetechnikk, NTNU
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
26667796
Citation
Leinan IM, Aamot IL, Stoylen A, Karlsen T, Wisloff U. Upper arm venous compliance and fitness in stable coronary artery disease patients and healthy controls. Clin Physiol Funct Imaging. 2017 Sep;37(5):498-506. doi: 10.1111/cpf.12324. Epub 2015 Dec 15.
Results Reference
result
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Venous Function in Cardiovascular Disease Patients
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