Variation of Aortic Compliance Related to Exercise Training With or Without Supervised Sessions (ACT)

August 17, 2016 updated by: University Hospital Center of Martinique

Exercise Training in Patients With Cardiovascular Risk: Predictability of Aortic Compliance Normalization

Many conditions and cardiovascular diseases (including stroke) are better managed with regular exercise training. The expected effects are partial reversal of adverse effects on heart and blood vessel structure and function, improved glycemic, tension and weight control.

Physiologically, the aorta maintains low left ventricular after-load, promotes optimal sub-endocardial coronary blood flow, and transforms pulsatile into laminar blood flow. Increased aortic stiffness may ultimately contribute to left ventricular dysfunction. Regular exercise training is likely to decrease the pulse wave velocity (a measure of the aortic compliance). Some subjects seem more responsive than others, and they may not expect the same benefit of exercise training. To the best of our knowledge, this has not been explained yet.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

308

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

  • Guadeloupe
      • Pointe à Pitre, Guadeloupe
        • Recruiting
        • CHU de Pointe à Pitre
        • Contact:
        • Principal Investigator:
          • Cosmin ALECU, MD
        • Sub-Investigator:
          • Annie LANNUZEL, MD
        • Principal Investigator:
          • Anne BLANCHET, MD
        • Sub-Investigator:
          • Rachel BILLY-BRISSAC, MD
        • Principal Investigator:
          • Patrick FOUCAN, MD
  • Martinique
      • Fort de France, Martinique
        • Recruiting
        • CHU de Fort de France
        • Contact:
        • Sub-Investigator:
          • Patrick RENE-CORAIL, MD
        • Sub-Investigator:
          • Jocelyn INAMO, MD
        • Sub-Investigator:
          • Stéphane OLINDO, MD

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

50 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients aged 50-69 years, with moderate or high cardiovascular risk

Exclusion Criteria:

  • any physical or medical problem liable to limit the patient' ability to perform the cardiopulmonary exercise testing or the exercise training in safe conditions.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Medical supervision
Exercise training with supervised sessions Classics training
Procedure: Exercise training with supervised sessions
Active Comparator: No medical supervision
Exercise training without supervised sessions Classics training
Procedure: Exercise training with supervised sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pulse wave velocity
Time Frame: With or without the exercise training
With or without the exercise training

Secondary Outcome Measures

Outcome Measure
Time Frame
Heart rate variability
Time Frame: within 12 weeks after exercise training
within 12 weeks after exercise training

Collaborators and Investigators

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

Sponsor

University Hospital Center of Martinique

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

April 1, 2013

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

September 3, 2013

First Submitted That Met QC Criteria

September 5, 2013

First Posted (Estimate)

September 11, 2013

Study Record Updates

Last Update Posted (Estimate)

August 18, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/B/01
  • 2012-A00359-34 (Other Identifier: AFSSAPS)

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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