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Venous Function in Cardiovascular Disease Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01474408
First received: November 4, 2011
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Myocardial Infarction
 Behavioral: interval training day 1
Behavioral: Moderate exercise day 2
Behavioral: Control day 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Venous Function in Cardiovascular Disease Patients; The Neglected Part of Circulatory Regulation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Venous Compliance change [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Measured by echocardiography


Enrollment: 10
Study Start Date: November 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: interval training
4 x 4 minutes exercise at 90 - 95 % of peak heart rate separated with 3 minutes at 70 % of peaks heart rate
 Behavioral: interval training day 1
Other Name: aerobic interval training
Behavioral: Moderate exercise day 2 Behavioral: Control day 3
Active Comparator: moderate exercise
moderate continuous exercise at 70 % of peak heart rate on venous function.
 Behavioral: interval training day 1
Other Name: aerobic interval training
Behavioral: Moderate exercise day 2 Behavioral: Control day 3
control
routine measurements, no exercise
 Behavioral: interval training day 1
Other Name: aerobic interval training
Behavioral: Moderate exercise day 2 Behavioral: Control day 3

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474408

Locations
Norway
Institutt for Sirkulasjon og Bildetechnikk, NTNU
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Ingeborg M Leinan, MSc Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01474408     History of Changes
Other Study ID Numbers: 2011/760
Study First Received: November 4, 2011
Last Updated: January 9, 2013
Health Authority: Norway: Ethics Committee

Keywords provided by Norwegian University of Science and Technology:
Coronary artery bypass
Exercise therapy
Revascularization (PCI)

Additional relevant MeSH terms:
Cardiovascular Diseases
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013