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

• Sponsor: University Hospital Center of Martinique (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01939080
• Collaborator: (none)
• Enrollment: 308
• Locations: 2
• Arms: 2
• Duration (Months): 64
• Patients Per Site: 154
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Apr 1, 2013
• Anticipated Primary Completion Date: Jun 1, 2017
• Anticipated Study Completion Date: Aug 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pulse wave velocity [With or without the exercise training]

Secondary Outcome Measures

1. Heart rate variability [within 12 weeks after exercise training]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Pointe à Pitre	Pointe à Pitre		Guadeloupe
2	CHU de Fort de France	Fort de France		Martinique

Sponsors and Collaborators

• University Hospital Center of Martinique

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital Center of Martinique
• ClinicalTrials.gov Identifier: NCT01939080
• Other Study ID Numbers: 12/B/01; 2012-A00359-34
• First Posted: Sep 11, 2013
• Last Update Posted: Aug 18, 2016
• Last Verified: Aug 1, 2016

• Keywords provided by University Hospital Center of Martinique: moderate risk; high risk
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of Aug 18, 2016