Variation of Aortic Compliance Related to Exercise Training With or Without Supervised Sessions
ACT
Exercise Training in Patients With Cardiovascular Risk: Predictability of Aortic Compliance Normalization
2 other identifiers
interventional
308
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2013
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 3, 2013
CompletedFirst Posted
Study publicly available on registry
September 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedAugust 18, 2016
August 1, 2016
4.2 years
September 3, 2013
August 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pulse wave velocity
With or without the exercise training
Secondary Outcomes (1)
Heart rate variability
within 12 weeks after exercise training
Study Arms (2)
Medical supervision
ACTIVE COMPARATORExercise training with supervised sessions Classics training
No medical supervision
ACTIVE COMPARATORExercise training without supervised sessions Classics training
Interventions
Eligibility Criteria
You may qualify if:
- patients aged 50-69 years, with moderate or high cardiovascular risk
You may not qualify if:
- any physical or medical problem liable to limit the patient' ability to perform the cardiopulmonary exercise testing or the exercise training in safe conditions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU de Pointe à Pitre
Pointe-à-Pitre, Guadeloupe
CHU de Fort de France
Fort-de-France, Martinique
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2013
First Posted
September 11, 2013
Study Start
April 1, 2013
Primary Completion
June 1, 2017
Study Completion
August 1, 2018
Last Updated
August 18, 2016
Record last verified: 2016-08