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

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ClinicalTrials.gov Identifier: NCT01939080
Recruitment Status : Unknown
Verified August 2016 by University Hospital Center of Martinique.
Recruitment status was:  Recruiting
First Posted : September 11, 2013
Last Update Posted : August 18, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital Center of Martinique

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cardiovascular Disease Procedure: Exercise training with supervised sessions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Exercise Training in Patients With Cardiovascular Risk: Predictability of Aortic Compliance Normalization
Study Start Date : April 2013
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Pulse wave velocity [ Time Frame: With or without the exercise training ]

Secondary Outcome Measures :
  1. Heart rate variability [ Time Frame: within 12 weeks after exercise training ]


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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939080


Contacts
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Contact: Armelle JEAN-ETIENNE, MD Armelle.Jean-Etienne@chu-fortdefrance.fr

Locations
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Guadeloupe
CHU de Pointe à Pitre Recruiting
Pointe à Pitre, Guadeloupe
Contact: Sophie ANTOINE-JONVILLE, Ph.D.       s_antoine@ymail.com   
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
CHU de Fort de France Recruiting
Fort de France, Martinique
Contact: Armelle JEAN-ETIENNE, MD       Armelle.Jean-Etienne@chu-fortdefrance.fr   
Sub-Investigator: Patrick RENE-CORAIL, MD         
Sub-Investigator: Jocelyn INAMO, MD         
Sub-Investigator: Stéphane OLINDO, MD         
Sponsors and Collaborators
University Hospital Center of Martinique

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Responsible Party: University Hospital Center of Martinique
ClinicalTrials.gov Identifier: NCT01939080     History of Changes
Other Study ID Numbers: 12/B/01
2012-A00359-34 ( Other Identifier: AFSSAPS )
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: August 2016

Keywords provided by University Hospital Center of Martinique:
moderate risk
high risk

Additional relevant MeSH terms:
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Cardiovascular Diseases