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More Intensive Cardiac Rehabilitation Programs in Less Time (másPORmenos)

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Intensive cardiac rehabilitation program in less time
Sponsored by
Almudena Castro Conde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Coronary Syndrome focused on measuring Cardiac rehabilitation programs, Adherence to secondary preventive measures, Acute coronary syndrome, More intensive cardiac rehabilitation program in less time

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario La Paz

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Intensivo

Convencional

Arm Description

intensive cardiac rehabilitation program in less time

standard cardiac rehabilitation program

Outcomes

Primary Outcome Measures

Adherence to physical exercise
Assessed in Metabolic Equivalents of Task (METS) from baseline by ergometry
Adherence to Mediterranean diet
Assessed by Mediterranean diet adherence questionnaire (Modified Trichopoulou A,)
Tabacco abstinence
Assessed by cooximetry (less dan 10 ppm)
Number of participants reporting compliance with prescribed treatments
Patient-reported answers form the investigator

Secondary Outcome Measures

Full Information

First Posted
October 4, 2015
Last Updated
June 5, 2018
Sponsor
Almudena Castro Conde
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1. Study Identification

Unique Protocol Identification Number
NCT02619422
Brief Title
More Intensive Cardiac Rehabilitation Programs in Less Time
Acronym
másPORmenos
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Almudena Castro Conde

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 an standard cardiac rehabilitation program

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Cardiac rehabilitation programs, Adherence to secondary preventive measures, Acute coronary syndrome, More intensive cardiac rehabilitation program in less time

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
509 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensivo
Arm Type
Other
Arm Description
intensive cardiac rehabilitation program in less time
Arm Title
Convencional
Arm Type
No Intervention
Arm Description
standard cardiac rehabilitation program
Intervention Type
Other
Intervention Name(s)
Intensive cardiac rehabilitation program in less time
Intervention Description
2 weeks, 5 days a week, and reinforcement sessions at 3, 6 and 9 months
Primary Outcome Measure Information:
Title
Adherence to physical exercise
Description
Assessed in Metabolic Equivalents of Task (METS) from baseline by ergometry
Time Frame
baseline-12 months
Title
Adherence to Mediterranean diet
Description
Assessed by Mediterranean diet adherence questionnaire (Modified Trichopoulou A,)
Time Frame
baseline-12 months
Title
Tabacco abstinence
Description
Assessed by cooximetry (less dan 10 ppm)
Time Frame
baseline-12 months
Title
Number of participants reporting compliance with prescribed treatments
Description
Patient-reported answers form the investigator
Time Frame
baseline-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
08046
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
32807709
Citation
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.
Results Reference
derived

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More Intensive Cardiac Rehabilitation Programs in Less Time

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