Acute Coronary SyndromemásPORmenosNCT02619422
More Intensive Cardiac Rehabilitation Programs in Less Time
A study testing Intensive cardiac rehabilitation program in less time in people with Acute Coronary Syndrome, run by Almudena Castro Conde at 1 site in Spain.
Trial summary
To determine if an intensive cardiac rehabilitation program with periodic reinforcements improve the compliance/adherence to secondary preventive measures (physical exercise, mediterranean diet, tobacco abstinence, pharmacological treatment) after an acute coronary syndrome with or without ST segment elevation versus… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Intensive cardiac rehabilitation program in less time
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 509 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2015to 28 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Equal or older 18 years old
- Acute coronary syndrome with or without ST elevation within last two months
- Being able to do physical exercise
- Being able to understand the educative sessions
- Being able to understand patient information in the consent form
Who cannot join
- Hemodynamic instability
- Left ventricular ejection fraction (LVEF) < or = 35%
- Heart failure class III -IV (New York Heart Association (NYHA) Functional Classification)
- Refractory angina
- Any pathology for which physical exercise is not indicated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Prospective, Randomized, Open, Blinded for the End Point Evaluator to Compare Compliance to Secondary Prevention Measures After Acute Coronary Syndrome and Intensive Cardiac Rehabilitation Program vs Standard Program
To determine if an intensive cardiac rehabilitation program with periodic reinforcements improve the compliance/adherence to secondary preventive measures (physical exercise, mediterranean diet, tobacco abstinence, pharmacological treatment) after an acute coronary syndrome with or without ST segment elevation versus an standard cardiac rehabilitation program
- Conditions
- Acute Coronary Syndrome
- Being tested
- Intensive cardiac rehabilitation program in less time
- Keywords
- Cardiac rehabilitation programs, Adherence to secondary preventive measures, Acute coronary syndrome, More intensive cardiac rehabilitation program in less time
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive cardiac rehabilitation program in less timeOther
2 weeks, 5 days a week, and reinforcement sessions at 3, 6 and 9 months
| Study group | Role | What they receive |
|---|---|---|
| Intensivo | Other | intensive cardiac rehabilitation program in less time Receives: Other: Intensive cardiac rehabilitation program in less time |
| Convencional | No intervention | standard cardiac rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to physical exercise
Assessed in Metabolic Equivalents of Task (METS) from baseline by ergometry
Measured: baseline-12 months
Adherence to Mediterranean diet
Assessed by Mediterranean diet adherence questionnaire (Modified Trichopoulou A,)
Measured: baseline-12 months
Tabacco abstinence
Assessed by cooximetry (less dan 10 ppm)
Measured: baseline-12 months
Number of participants reporting compliance with prescribed treatments
Patient-reported answers form the investigator
Measured: baseline-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionFeb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almudena Castro Conde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Almudena Castro Conde, Spanish Society of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619422
- Sponsor's protocol ID
- másPORmenos
- Acronym
- másPORmenos
- Status last verified
- Jun 2018
- First submitted
- 4 Oct 2015
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Castro-Conde A, Abeytua M, Arrarte Esteban VI, Caravaca Perez P, Dalmau Gonzalez-Gallarza R, Garza Benito F, Hidalgo Urbano RJ, Torres Marques J, Vidal-Perez R, Nunez-Gil IJ. Feasibility and results of an intensive cardiac rehabilitation program. Insights from the MxM (Mas por Menos) randomized trial. Rev Esp Cardiol (Engl Ed). 2021 Jun;74(6):518-525. doi: 10.1016/j.rec.2020.03.029. Epub 2020 Aug 15. English, Spanish.
PubMed 32807709
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Randomized, Open, Blinded for the End Point Evaluator to Compare Compliance to Secondary Prevention Measures After Acute Coronary Syndrome and Intensive Cardiac Rehabilitation Program vs Standard Program
- ClinicalTrials.gov ID
- NCT02619422
- Acronym / sponsor ID
- másPORmenos / másPORmenos
- Conditions
- Acute Coronary Syndrome
- Keywords
- Cardiac rehabilitation programs, Adherence to secondary preventive measures, Acute coronary syndrome, More intensive cardiac rehabilitation program in less time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Almudena Castro CondeUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 2 Dec 2015 (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.
To determine if an intensive cardiac rehabilitation program with periodic reinforcements improve the compliance/adherence to secondary preventive measures (physical exercise, mediterranean diet, tobacco abstinence, pharmacological treatment) after an acute coronary syndrome with or without ST segment elevation versus an standard cardiac rehabilitation program
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensivo | Other | Other: Intensive cardiac rehabilitation program in less timeintensive cardiac rehabilitation program in less time |
| Convencional | No intervention | –standard cardiac rehabilitation program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent
- Equal or older 18 years old
- Acute coronary syndrome with or without ST elevation within last two months
- Being able to do physical exercise
- Being able to understand the educative sessions
Key exclusion criteria (5 listed)
- Hemodynamic instability
- Left ventricular ejection fraction (LVEF) < or = 35%
- Heart failure class III -IV (New York Heart Association (NYHA) Functional Classification)
- Refractory angina
- Any pathology for which physical exercise is not indicated
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 |
|---|---|---|
| Intensive cardiac rehabilitation program in less time2 weeks, 5 days a week, and reinforcement sessions at 3, 6 and 9 months | Other | Intensivo |
Primary outcome
Adherence to physical exercise
Time frame: baseline-12 months
Assessed in Metabolic Equivalents of Task (METS) from baseline by ergometry
Adherence to Mediterranean diet
Time frame: baseline-12 months
Assessed by Mediterranean diet adherence questionnaire (Modified Trichopoulou A,)
Tabacco abstinence
Time frame: baseline-12 months
Assessed by cooximetry (less dan 10 ppm)
Number of participants reporting compliance with prescribed treatments
Time frame: baseline-12 months
Patient-reported answers form the investigator
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Derived from this study: PubMed 32807709Castro-Conde A, Abeytua M, Arrarte Esteban VI, Caravaca Perez P, Dalmau Gonzalez-Gallarza R, Garza Benito F, Hidalgo Urbano RJ, Torres Marques J, Vidal-Perez R, Nunez-Gil IJ. Feasibility and results of an intensive cardiac rehabilitation program. Insights from the MxM (Mas por Menos) randomized trial. Rev Esp Cardiol (Engl Ed). 2021 Jun;74(6):518-525. doi: 10.1016/j.rec.2020.03.029. Epub 2020 Aug 15. English, Spanish.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive cardiac rehabilitation program in less time in people with Acute Coronary Syndrome, run by Almudena Castro Conde at 1 site in Spain.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to physical exercise (time frame: baseline-12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02619422, which also lists 1 linked publication.
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 6 Jun 2018.