More Intensive Cardiac Rehabilitation Programs in Less Time

NCT ID: NCT02619422

Last Updated: 2018-06-06

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

COMPLETED

Clinical Phase

NA

Total Enrollment

509 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intensivo

intensive cardiac rehabilitation program in less time

Group Type OTHER

Intensive cardiac rehabilitation program in less time

Intervention Type OTHER

2 weeks, 5 days a week, and reinforcement sessions at 3, 6 and 9 months

Convencional

standard cardiac rehabilitation program

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intensive cardiac rehabilitation program in less time

2 weeks, 5 days a week, and reinforcement sessions at 3, 6 and 9 months

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Almudena Castro Conde

OTHER

Sponsor Role lead

Responsible Party

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Almudena Castro Conde

MD, PhD, Cardiology Department Staff, Hospital Universitario La Paz , Madrid

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hospital Universitario La Paz

Madrid, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 32807709 (View on PubMed)

Other Identifiers

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másPORmenos

Identifier Type: -

Identifier Source: org_study_id

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