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

Cardiovascular Disease Clinical Trial

— ACT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01939080
• Other study ID #: 12/B/01
• Secondary ID: 2012-A00359-34
• Status: Recruiting
• Phase: N/A
• First received: September 3, 2013
• Last updated: August 17, 2016
• Start date: April 2013
• Est. completion date: August 2018

Study information

• Verified date: August 2016
• Source: University Hospital Center of Martinique
• Contact: Armelle JEAN-ETIENNE, MD
• Email: Armelle.Jean-Etienne[@]chu-fortdefrance.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 308
• Est. completion date: August 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 69 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Procedure:
• Exercise training with supervised sessions

Locations

Country	Name	City	State
Guadeloupe	CHU de Pointe à Pitre	Pointe à Pitre
Martinique	CHU de Fort de France	Fort de France

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Center of Martinique

Countries where clinical trial is conducted

Guadeloupe,  Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse wave velocity		With or without the exercise training	No
Secondary	Heart rate variability		within 12 weeks after exercise training	No