High Intensity Aerobic Interval Training With Mediterranean Diet Recommendations in Post-Myocardial Infarct Patients

NCT02876952 | Unknown DMC

• 1 other identifier: BasqueCU
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

Cardio-respiratory fitness; high intensity exercise training

Outcome Measures

Primary Outcomes (1)

• Direct Cardio-respiratory fitness

  Direct cardio-respiratory fitness will be evaluated through objectives variables such as peak oxygen uptake and ventilatory thresholds with a cardio pulmonary exercise test.

  16 weeks

Secondary Outcomes (15)

• Left Ventricular Function

  16 weeks

• Biochemical measures: lipid metabolism

  16 weeks

• Biochemical measures: general metabolism

  16 weeks

• Biochemical measures: myocardial stress and damage

  16 weeks

• Quality of Life

  16 weeks

Study Arms (3)

Attention Control Group (AC)

ACTIVE COMPARATOR

Moderate to high- intensity physical activity and Mediterranean Diet recommendations

Other: Mediterranean Diet Recommendations; Other: Physical Activity Recommendations

HV-HIIT

EXPERIMENTAL

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; Other: Mediterranean Diet Recommendations

LV-HIIT

EXPERIMENTAL

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; Other: LOW VOLUME (LW) Supervised exercise

Interventions

HIGH VOLUME (HV) Supervised exercise OTHER

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

HV-HIIT

Mediterranean Diet Recommendations OTHER

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.

Attention Control Group (AC); HV-HIIT; LV-HIIT

Physical Activity Recommendations OTHER

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.

Attention Control Group (AC)

LOW VOLUME (LW) Supervised exercise OTHER

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.

LV-HIIT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead
• HOSPITAL SANTIAGO APOSTOL. MIRANDA DE EBRO. BURGOS. SPAIN: collaborator

Study Sites (1)

Department of Physical Education and Sport. Faculty of Education and Sport-Physical Activity and Sport Section. University of the Basque Country

Vitoria-Gasteiz, Araba/álava, 01007, Spain

RECRUITING

Related Publications (12)

• Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC); Steg PG, James SK, Atar D, Badano LP, Blomstrom-Lundqvist C, Borger MA, Di Mario C, Dickstein K, Ducrocq G, Fernandez-Aviles F, Gershlick AH, Giannuzzi P, Halvorsen S, Huber K, Juni P, Kastrati A, Knuuti J, Lenzen MJ, Mahaffey KW, Valgimigli M, van 't Hof A, Widimsky P, Zahger D. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2012 Oct;33(20):2569-619. doi: 10.1093/eurheartj/ehs215. Epub 2012 Aug 24. No abstract available.

  PMID: 22922416 BACKGROUND

• 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, Menasche 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. No abstract available.

  PMID: 22923432 BACKGROUND

• Mezzani A, Hamm LF, Jones AM, McBride PE, Moholdt T, Stone JA, Urhausen A, Williams MA; European Association for Cardiovascular Prevention and Rehabilitation; American Association of Cardiovascular and Pulmonary Rehabilitation; Canadian Association of Cardiac Rehabilitation. Aerobic exercise intensity assessment and prescription in cardiac rehabilitation: a joint position statement of the European Association for Cardiovascular Prevention and Rehabilitation, the American Association of Cardiovascular and Pulmonary Rehabilitation, and the Canadian Association of Cardiac Rehabilitation. J Cardiopulm Rehabil Prev. 2012 Nov-Dec;32(6):327-50. doi: 10.1097/HCR.0b013e3182757050.

  PMID: 23103476 BACKGROUND

• Piepoli MF, Corra U, Adamopoulos S, Benzer W, Bjarnason-Wehrens B, Cupples M, Dendale P, Doherty P, Gaita D, Hofer S, McGee H, Mendes M, Niebauer J, Pogosova N, Garcia-Porrero E, Rauch B, Schmid JP, Giannuzzi P. Secondary prevention in the clinical management of patients with cardiovascular diseases. Core components, standards and outcome measures for referral and delivery: a policy statement from the cardiac rehabilitation section of the European Association for Cardiovascular Prevention & Rehabilitation. Endorsed by the Committee for Practice Guidelines of the European Society of Cardiology. Eur J Prev Cardiol. 2014 Jun;21(6):664-81. doi: 10.1177/2047487312449597. Epub 2012 Jun 20.

  PMID: 22718797 BACKGROUND

• Piepoli MF, Conraads V, Corra U, Dickstein K, Francis DP, Jaarsma T, McMurray J, Pieske B, Piotrowicz E, Schmid JP, Anker SD, Solal AC, Filippatos GS, Hoes AW, Gielen S, Giannuzzi P, Ponikowski PP. Exercise training in heart failure: from theory to practice. A consensus document of the Heart Failure Association and the European Association for Cardiovascular Prevention and Rehabilitation. Eur J Heart Fail. 2011 Apr;13(4):347-57. doi: 10.1093/eurjhf/hfr017.

  PMID: 21436360 BACKGROUND

• Vanhees L, Rauch B, Piepoli M, van Buuren F, Takken T, Borjesson M, Bjarnason-Wehrens B, Doherty P, Dugmore D, Halle M; Writing Group, EACPR. Importance of characteristics and modalities of physical activity and exercise in the management of cardiovascular health in individuals with cardiovascular disease (Part III). Eur J Prev Cardiol. 2012 Dec;19(6):1333-56. doi: 10.1177/2047487312437063.

  PMID: 22637740 BACKGROUND

• Guiraud T, Nigam A, Gremeaux V, Meyer P, Juneau M, Bosquet L. High-intensity interval training in cardiac rehabilitation. Sports Med. 2012 Jul 1;42(7):587-605. doi: 10.2165/11631910-000000000-00000.

  PMID: 22694349 BACKGROUND

• Gibala MJ, Little JP, Macdonald MJ, Hawley JA. Physiological adaptations to low-volume, high-intensity interval training in health and disease. J Physiol. 2012 Mar 1;590(5):1077-84. doi: 10.1113/jphysiol.2011.224725. Epub 2012 Jan 30.

  PMID: 22289907 BACKGROUND

• Martinez-Gonzalez MA, Salas-Salvado J, Estruch R, Corella D, Fito M, Ros E; PREDIMED INVESTIGATORS. Benefits of the Mediterranean Diet: Insights From the PREDIMED Study. Prog Cardiovasc Dis. 2015 Jul-Aug;58(1):50-60. doi: 10.1016/j.pcad.2015.04.003. Epub 2015 May 1.

  PMID: 25940230 BACKGROUND

• Sofi F, Cesari F, Abbate R, Gensini GF, Casini A. Adherence to Mediterranean diet and health status: meta-analysis. BMJ. 2008 Sep 11;337:a1344. doi: 10.1136/bmj.a1344.

  PMID: 18786971 BACKGROUND

• Aispuru-Lanche R, Jayo-Montoya JA, Maldonado-Martin S. Vascular-endothelial adaptations following low and high volumes of high-intensity interval training in patients after myocardial infarction. Ther Adv Cardiovasc Dis. 2024 Jan-Dec;18:17539447241286036. doi: 10.1177/17539447241286036.

  PMID: 39380195 DERIVED

• Maldonado-Martin S, Jayo-Montoya JA, Matajira-Chia T, Villar-Zabala B, Goiriena JJ, Aispuru GR. Effects of combined high-intensity aerobic interval training program and Mediterranean diet recommendations after myocardial infarction (INTERFARCT Project): study protocol for a randomized controlled trial. Trials. 2018 Mar 2;19(1):156. doi: 10.1186/s13063-018-2529-3.

  PMID: 29499766 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• SARA MALDONADO-MARTIN, PhD

  UNIVERSITY OF THE BASQUE COUNTRY. Department of Physical Education and Sport

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SARA MALDONADO-MARTIN, PhD

CONTACT

+34945013534; sara.maldonado@ehu.eus

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Professor

Study Record Dates

• First Submitted: August 7, 2016
• First Posted: August 24, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: June 20, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)