Cardiovascular DiseaseACTNCT01939080
Variation of Aortic Compliance Related to Exercise Training With or Without Supervised Sessions
A study testing Exercise training with supervised sessions in people with Cardiovascular Disease, run by University Hospital Center of Martinique at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 50 to 69 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Exercise training with supervised sessions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2013to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 50-69 years, with moderate or high cardiovascular risk
Who cannot join
- any physical or medical problem liable to limit the patient' ability to perform the cardiopulmonary exercise testing or the exercise training in safe conditions.
Trial locations and contacts
2 sites in 2 countries.
Armelle JEAN-ETIENNE, MD contact
2 sites in 2 countries
Guadeloupe1 site, 1 recruiting
- Recruiting
CHU de Pointe à Pitre
Pointe-à-Pitre
Sophie ANTOINE-JONVILLE, Ph.D., s_antoine@ymail.com
Cosmin ALECU, MD
Martinique1 site, 1 recruiting
- Recruiting
CHU de Fort de France
Fort-de-France
Armelle JEAN-ETIENNE, MD, Armelle.Jean-Etienne@chu-fortdefrance.fr
Patrick RENE-CORAIL, MD
About this study
Official title: Exercise Training in Patients With Cardiovascular Risk: Predictability of Aortic Compliance Normalization
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.
- Conditions
- Cardiovascular Disease
- Being tested
- Exercise training with supervised sessions
- Keywords
- moderate risk, high risk
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise training with supervised sessionsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Medical supervision | Active comparator | Exercise training with supervised sessions Classics training Receives: Procedure: Exercise training with supervised sessions |
| No medical supervision | Active comparator | Exercise training without supervised sessions Classics training Receives: Procedure: Exercise training with supervised sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse wave velocity
Measured: With or without the exercise training
Secondary outcomes (1)
Heart rate variability
Measured: within 12 weeks after exercise training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2017 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939080
- Sponsor's protocol ID
- 12/B/01
- Other IDs
- 2012-A00359-34
- Acronym
- ACT
- Status last verified
- Aug 2016
- First submitted
- 3 Sep 2013
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training in Patients With Cardiovascular Risk: Predictability of Aortic Compliance Normalization
- ClinicalTrials.gov ID
- NCT01939080
- Acronym / sponsor ID
- ACT / 12/B/01
- Conditions
- Cardiovascular Disease
- Keywords
- moderate risk, high risk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 11 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical supervision | Active comparator | Procedure: Exercise training with supervised sessionsExercise training with supervised sessions Classics training |
| No medical supervision | Active comparator | Procedure: Exercise training with supervised sessionsExercise training without supervised sessions Classics training |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients aged 50-69 years, with moderate or high cardiovascular risk
Key exclusion criteria (1 listed)
- any physical or medical problem liable to limit the patient' ability to perform the cardiopulmonary exercise testing or the exercise training in safe conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise training with supervised sessions | Procedure or surgery | Medical supervision, No medical supervision |
Primary outcome
Pulse wave velocity
Time frame: With or without the exercise training
1 secondary outcome
Heart rate variability
Time frame: within 12 weeks after exercise training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armelle JEAN-ETIENNE, MD contact
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training with supervised sessions in people with Cardiovascular Disease, run by University Hospital Center of Martinique at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Guadeloupe, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Armelle JEAN-ETIENNE, MD (Armelle.Jean-Etienne@chu-fortdefrance.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse wave velocity (time frame: With or without the exercise training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2016.