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OpenTrials
Completed

NCT Number: NCT02619422

More Intensive Cardiac Rehabilitation Programs in Less Time

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

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario La Paz

Madrid, 08046, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive cardiac rehabilitation program in less time

Other

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

Primary outcomes

  1. Adherence to physical exercise

    Time frame: baseline-12 months

    Assessed in Metabolic Equivalents of Task (METS) from baseline by ergometry

  2. Adherence to Mediterranean diet

    Time frame: baseline-12 months

    Assessed by Mediterranean diet adherence questionnaire (Modified Trichopoulou A,)

  3. Tabacco abstinence

    Time frame: baseline-12 months

    Assessed by cooximetry (less dan 10 ppm)

  4. Number of participants reporting compliance with prescribed treatments

    Time frame: baseline-12 months

    Patient-reported answers form the investigator

Sponsors and collaborators

Lead sponsor

Almudena Castro Conde

Other

Registry information

Official study 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

Acronym: másPORmenos

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 2, 2015
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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