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

NCT ID: NCT01939080

Last Updated: 2016-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Medical supervision

Exercise training with supervised sessions Classics training

Group Type ACTIVE_COMPARATOR

Exercise training with supervised sessions

Intervention Type PROCEDURE

No medical supervision

Exercise training without supervised sessions Classics training

Group Type ACTIVE_COMPARATOR

Exercise training with supervised sessions

Intervention Type PROCEDURE

Interventions

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Exercise training with supervised sessions

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Center of Martinique

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Pointe à Pitre

Pointe-à-Pitre, , Guadeloupe

Site Status RECRUITING

CHU de Fort de France

Fort-de-France, , Martinique

Site Status RECRUITING

Countries

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Guadeloupe Martinique

Central Contacts

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Armelle JEAN-ETIENNE, MD

Role: CONTACT

Facility Contacts

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Sophie ANTOINE-JONVILLE, Ph.D.

Role: primary

Armelle JEAN-ETIENNE, MD

Role: primary

Other Identifiers

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2012-A00359-34

Identifier Type: OTHER

Identifier Source: secondary_id

12/B/01

Identifier Type: -

Identifier Source: org_study_id

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