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Trial record 1 of 1 for:    18786971 [PUBMED-IDS]
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High Intensity Aerobic Interval Training With Mediterranean Diet Recommendations in Post-Myocardial Infarct Patients (INTERFARCT)

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ClinicalTrials.gov Identifier: NCT02876952
Recruitment Status : Unknown
Verified June 2017 by SARA MALDONADO-MARTIN, Basque Country University.
Recruitment status was:  Recruiting
First Posted : August 24, 2016
Last Update Posted : June 20, 2017
Sponsor:
Collaborator:
HOSPITAL SANTIAGO APOSTOL. MIRANDA DE EBRO. BURGOS. SPAIN
Information provided by (Responsible Party):
SARA MALDONADO-MARTIN, Basque Country University

Brief Summary:

Acute myocardial infarction (MI) continues remains to be a major cause of death and disability worldwide. Exercise therapy has long been used for rehabilitation purposes and the benefit of regular physical exercise is also well established. The intensity of aerobic exercise training is a key issue in cardiac rehabilitation programmes.Endurance aerobic training is typically performed as continuous training at moderate to-high exercise intensity in steady-state conditions of aerobic energetic yield. However, interval training (i.e., repeated bouts of short-duration, high to severe- or severe to extreme-intensity exercise, separated by brief periods of lower-intensity) has been proposed to be more effective than continuous exercise for improving exercise capacity. Adding to that, health-related adaptations to low-volume and high intensity interval training have been presented.

On the other hand, the Mediterranean Diet has been widely reported to be a model of healthy eating for its contribution to a favourable health status and a better quality of life, reducing in overall mortality from cardiovascular diseases.

Considering all the above mentioned in MI population, the principal objective for the INTERFARCT study will be to assess the effects of different programs of high intensity aerobic interval training and Mediterranean Diet recommendations in the clinical condition, cardio-respiratory fitness, biomarkers, ventricular function and perception of quality of life after myocardial infarction.

Methods/Design: One hundred and fifty people after suffering acute MI will perform different assessments to evaluate clinical history, physical, biochemical and nutritional condition, and quality of life before and after 16-week of follow-up. All participants will receive Mediterranean diet recommendations and will be randomly assigned to attention control group (diet and physical activity recommendations) or exercise groups (diet recommendations plus high-intensity aerobic interval exercise). Participants assigned to an exercise group will train 2 days/week under supervision (day 1-treadmill and day 2-bike protocol). There will be two aerobic exercise groups: 1) high-intensity interval training and high-volume (HV-HIIT) group, and 2) high-intensity interval training and low-volume (LV-HIIT) group.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Other: HIGH VOLUME (HV) Supervised exercise Other: Mediterranean Diet Recommendations Other: Physical Activity Recommendations Other: LOW VOLUME (LW) Supervised exercise Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Combined High Intensity Aerobic Interval Training Program and Mediterranean Diet Recommendations in Post-Myocardial Infarct Patients: INTERFARCT Controlled Trial
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Attention Control Group (AC)
Moderate to high- intensity physical activity and Mediterranean Diet recommendations
Other: Mediterranean Diet Recommendations

Participants will be interviewed regarding their usual eating habits. They will receive practical information about which are the Mediterranean Diet (DMed) foods according to the model proposed in the "PREDIMED" trial. Medical doctors or nurses will give this information.

Before starting the program of intervention, participants will assist to an informative talk in which benefits for the health of the DMed will be exposed and general information about food composition, frequencies of consumption, etc. will be explained.

Nutritional management: Diet reviews and body mass control will be performed every two weeks to assess the body composition and adherence to treatment. In the event of poor compliance strategies will be addressed for its correction.


Other: Physical Activity Recommendations
Participants will be advised to perform, without supervision, moderate to high-intensity dynamic aerobic exercise (walking, jogging, cycling or swimming) 3-5 days per week, following an adequate warm-up of 5-15 min, at moderate to high intensity (below the ischemic threshold) for a period of 20 to 40 min (not including warm-up and cool-down) followed by a cool-down period of 5-10min. Participants will receive information related to heart rate values regarding moderate and high exercise intensity domains for the self monitoring of exercise intensity.

Experimental: HV-HIIT

Supervised high volume and high intensity interval training exercise group with Mediterranean Diet recommendations.

High-intensity [heart rate (HR) values up to second ventilatory threshold (VT2) to peak intensity] interval training and high-volume increasing gradually from 20 to 40 min and alternating high and moderate [HR values between first ventilatory threshold (VT1) and VT2] intensities at different protocols.

Other: HIGH VOLUME (HV) Supervised exercise

Supervised exercise two nonconsecutive days per week (day 1-on the treadmill, day 2-on the bike) for 16 weeks. High-intensity interval training (HIIT) protocol on the treadmill: 5-min warm-up at a moderate-intensity, before walking 2 intervals of 4 min at high-intensity interspersed with intervals of 3 min of walking at moderate-intensity. 1-4 min cool-down at moderate-intensity.

HIIT protocol on the bike: 5 to 10-min warm-up at moderate intensity. After that, 4 repetitions (1rep = 30 s high-intensity followed by 60 s moderate-intensity) and gradually increased to 16 repetitions in HV-HIIT week by week. 5-10 min cool-down at moderate-intensity


Other: Mediterranean Diet Recommendations

Participants will be interviewed regarding their usual eating habits. They will receive practical information about which are the Mediterranean Diet (DMed) foods according to the model proposed in the "PREDIMED" trial. Medical doctors or nurses will give this information.

Before starting the program of intervention, participants will assist to an informative talk in which benefits for the health of the DMed will be exposed and general information about food composition, frequencies of consumption, etc. will be explained.

Nutritional management: Diet reviews and body mass control will be performed every two weeks to assess the body composition and adherence to treatment. In the event of poor compliance strategies will be addressed for its correction.


Experimental: LV-HIIT

Supervised low volume and high intensity interval training exercise group with Mediterranean Diet recommendations.

High-intensity (HR values up to VT2 to peak intensity) interval training and low-volume (20 min) alternating high and moderate (HR values between VT1 and VT2) intensities at different protocols.

Other: Mediterranean Diet Recommendations

Participants will be interviewed regarding their usual eating habits. They will receive practical information about which are the Mediterranean Diet (DMed) foods according to the model proposed in the "PREDIMED" trial. Medical doctors or nurses will give this information.

Before starting the program of intervention, participants will assist to an informative talk in which benefits for the health of the DMed will be exposed and general information about food composition, frequencies of consumption, etc. will be explained.

Nutritional management: Diet reviews and body mass control will be performed every two weeks to assess the body composition and adherence to treatment. In the event of poor compliance strategies will be addressed for its correction.


Other: LOW VOLUME (LW) Supervised exercise
Supervised exercise two nonconsecutive days per week (one day on the treadmill, and the second one on the bike) for 16 weeks. HIIT protocol on the treadmill: 5-min warm-up at a moderate-intensity, before walking 2 intervals of 4 min at high-intensity interspersed with intervals of 3 min of walking at moderate-intensity. The training session will end with a 1-4 min cool-down period at moderate-intensity. Total exercise time of 20min HIIT protocol on the bike: 10-min warm-up at moderate intensity. After that, participants will cycle for 4 repetitions (1rep = 30 s high-intensity followed by 60 s moderate-intensity) and gradually increased to 8 repetitions in LV-HIIT week by week. The training session will end with a 5-10 min cool-down period at moderate-intensity.




Primary Outcome Measures :
  1. Direct Cardio-respiratory fitness [ Time Frame: 16 weeks ]
    Direct cardio-respiratory fitness will be evaluated through objectives variables such as peak oxygen uptake and ventilatory thresholds with a cardio pulmonary exercise test.


Secondary Outcome Measures :
  1. Left Ventricular Function [ Time Frame: 16 weeks ]
    Left ventricular function will focus on the assessment of cardiovascular hemodynamics by cardiac ultrasound, global cardiac mechanics in systole and diastole, and the relationship between the cardiac structure and regional myocardial function.

  2. Biochemical measures: lipid metabolism [ Time Frame: 16 weeks ]

    Medical doctors will ask for a biochemical analysis including all the below variables to analyze the lipid metabolism of participant:

    Lipid metabolism: total cholesterol (mg/dL), low-density lipoprotein cholesterol (mg/dL), high-density lipoprotein cholesterol (mg/dL), Triglycerides (mg/dL).


  3. Biochemical measures: general metabolism [ Time Frame: 16 weeks ]

    Medical doctors will ask for a general biochemical analysis including all the below variables to analyze a general participant's profile related to:

    General metabolism: urea (mg/dL), creatinine (mg/dL), glomerular filtrate (mL/min), basal glucose (mg/dL), HbA1c (%), insulin, homoeostasis model assessment index (HOMA), uric acid (mg/dL), ionogram, alanine aminotransferase (U/L), aspartate aminotransferase (U/L), blood count.


  4. Biochemical measures: myocardial stress and damage [ Time Frame: 16 weeks ]

    Medical doctors will ask for a general biochemical analysis including all the below variables to analyze a general participant's profile:

    Myocardial damage: troponin T (ng/dL), total and creatine phosphokinase cardiac specific isoenzyme (MB) (U/mL).

    Myocardial stress: brain natriuretic peptide (pg/mL). Neuro-hormonal state: renin, aldosterone (ng/dL). Systemic inflammation: protein C reactive (PCRus) (mg/dL), Interleukin 6 (IL-6) (pg/mL), Tumor necrosis factor-alpha (TNF-alpha) (pg/mL).

    Procoagulant state: D-dimer (ng/mL), fibrinogen (mg/dL). Oxidative stress: ox-LDL (units/mL).


  5. Quality of Life [ Time Frame: 16 weeks ]
    Participants' health-related quality of life will be determined using the 36-item Short Form Medical Outcome Questionnaire (SF-36).

  6. Vascular endothelial function [ Time Frame: 16 weeks ]
    Determination of carotid artery-intima-media thickness through carotid ultrasonography.

  7. Dietary Assessment: dietary recall [ Time Frame: 16 weeks ]
    Dietary intake and habits will be assessed by subjective assessments using open-ended surveys such as dietary recalls or records

  8. Dietary Assessment: food frequency questionnaire [ Time Frame: 16 weeks ]
    Dietary intake and habits will be assessed by subjective assessments using closed-ended surveys including food frequency questionnaires

  9. Dietary Assessment:Mediterranean Diet Adherence Screener questionnaire [ Time Frame: 16 weeks ]
    Dietary intake and habits will be assessed by subjective assessments using Mediterranean Diet Adherence Screener questionnaire.

  10. Height [ Time Frame: 16 weeks ]
    Height (cm)

  11. Body mass [ Time Frame: 16 weeks ]
    body mass (kg)

  12. Waist and hip ratio [ Time Frame: 16 weeks ]
    Measurements:waist and hip perimeters (cm).

  13. Indirect cardiorespiratory fitness [ Time Frame: 16-weeks ]
    Indirect cardiorespiratory fitness will be assessed through a fiel test called Modified Shuttle Walk Test

  14. Assessment of state of depression and anxiety [ Time Frame: 16 weeks ]
    Self-assessment scale instrument for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic: Hospital Anxiety & Depression Scale

  15. Body composition [ Time Frame: 16 weeks ]
    Bioelectrical impedance analysis (BIA) is a commonly used method for estimating body composition, and in particular body fat, fat free body fat and water. All of them as a percentage of the total body mass



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Two months to 10 years from the cardiovascular event.
  • Left ventricular ejection fraction > 30%
  • Ability to undertake regular physical activity (walking and biking)

Exclusion Criteria:

  • Moderate to severe heart valvular disease.
  • Atrial fibrilation.
  • Uncontrolled atrial or ventricular arrhythmias.
  • Exercise induced myocardial ischaemia.
  • Pericardial disease.
  • Uncontrolled hypertension.
  • Insulin dependent diabetes mellitus.
  • Moderate to severe chronic lung disease (Vital capacity and/or forced expiratory volume during the first second <80% to that expected for the age).
  • Severe kidney disease (renal creatinine clearance <30 mL/min, calculated by Cockcroft-Gault formula).
  • Anaemia (haemoglobin <12 g/dL).
  • Life expectancy less than one year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876952


Contacts
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Contact: SARA MALDONADO-MARTIN, PhD +34945013534 sara.maldonado@ehu.eus

Locations
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Spain
Department of Physical Education and Sport. Faculty of Education and Sport-Physical Activity and Sport Section. University of the Basque Country Recruiting
Vitoria-gasteiz, Araba/álava, Spain, 01007
Contact: SARA MALDONADO-MARTIN, PhD       sara.maldonado@ehu.eus   
Sub-Investigator: Juan Jose GOIRIENA, PhD         
Sponsors and Collaborators
Basque Country University
HOSPITAL SANTIAGO APOSTOL. MIRANDA DE EBRO. BURGOS. SPAIN
Investigators
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Principal Investigator: SARA MALDONADO-MARTIN, PhD UNIVERSITY OF THE BASQUE COUNTRY. Department of Physical Education and Sport

Publications:
Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction, Katus HA, Lindahl B, Morrow DA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasché P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S. Third universal definition of myocardial infarction. Circulation. 2012 Oct 16;126(16):2020-35. doi: 10.1161/CIR.0b013e31826e1058. Epub 2012 Aug 24.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: SARA MALDONADO-MARTIN, PhD Professor, Basque Country University
ClinicalTrials.gov Identifier: NCT02876952     History of Changes
Other Study ID Numbers: BasqueCU
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data won't be shared
Keywords provided by SARA MALDONADO-MARTIN, Basque Country University:
Cardio-respiratory fitness
high intensity exercise training
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases