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Periodized Aerobic Interval Training in Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT03119493
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Laís M. Vanzella, Universidade Estadual Paulista Júlio de Mesquita Filho

Study Description
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Brief Summary:
Autonomic disfunction present in metabolic syndrome subjects is related by a greater vulnerability of the heart and risk of cardiovascular events. In this context, aerobic interval training has been highlighted by its easy applicability and benefits effects in autonomic modulation in different populations. Therefore the studies that use de aerobic interval training in this different populations didn't realize a periodization of training with preparatory periods with progressive increase of load, specific phases with less duration predominating the intensity and transition periods for recuperation. Additionally, there isn't studies that investigate the effects of aerobic interval training in autonomic modulation of individuals with metabolic syndrome. In this context, periodized aerobic interval training can arise like a new type of treatment that offering security and efficacy in subjects with metabolic syndrome. So, the aim of the study is evaluate the effect of periodized aerobic interval training in cardiac autonomic modulation and cardiovascular and anthropometric parameters of individuals with metabolic syndrome.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Metabolic Syndrome X Behavioral: Periodized aerobic interval training Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Periodized Aerobic Interval Training on Autonomic Modulation and Cardiovascular and Anthropometric Variables in Individuals With Metabolic Syndrome
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Periodized aerobic interval training
The experimental groups will participate in a 16 week, three times a week based-program of periodized aerobic interval training that consist in warming [5 minutes of general stretching and 5 minutes of walking on treadmill with heart rate less than 20 percent of heart rate reserve (HHR)], followed by periodized aerobic interval training on treadmill, and cooling down [5 minutes of walk in treadmill with a heart rate less than 20 percent of HRR and 5 minutes of rest]
 Behavioral: Periodized aerobic interval training
The periodized training program consist in 3 phases: light (I) (training range varying between 20 to 39% of heart rate reserve and active recuperation of 19% of heart rate reserve); moderate (II) (training range varying between 40 to 59% of heart rate reserve and active recuperation of 30% of heart rate reserve) and high (III) (training range varying between 70 to 90 % of heart rate reserve and active recuperation of 50% of heart rate reserve).
No Intervention: Control group
Participants in the control group will be instructed not to take part in any regular exercise programs during the study period.


Outcome Measures
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Primary Outcome Measures :
  1. Heart rate variability [ Time Frame: 16 week after allocation ]

Secondary Outcome Measures :
  1. Cardiovascular parameter : heart rate [ Time Frame: 16 week after allocation ]
  2. Cardiovascular parameter: blood pressure [ Time Frame: 16 week after allocation ]
  3. Anthropometric parameter: hit waist ratio [ Time Frame: 16 week after allocation ]
  4. Anthropometric parameter: abdominal circumference [ Time Frame: 16 week after allocation ]
  5. Anthropometric parameter: body mass index [ Time Frame: 16 week after allocation ]
    Measured by weight and height


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metabolic syndrome according to international diabetes federation (IDF) definition
  • Aged between 40 to 60 years

Exclusion Criteria:

  • Participants who are currently participating in any regular exercise programs last six months;
  • Use of drugs or medication (Except for risk factors of metabolic syndrome control);
  • Inflammatory or infectious process;
  • Musculotendinous or osteoarticular injuries in the lower limbs and/or spine;
  • Chronic pulmonary disease;
  • Neurological disorders;
  • Cardiovascular disease.
Contacts and Locations
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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): NCT03119493


Locations
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Brazil
Laís Manata Vanzella
Presidente Prudente, São Paulo, Brazil, 19.060-900
Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Investigators
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Study Director: Luiz Carlos M Vanderlei, PHD Universidade Estadual Paulista - UNESP campus de Presidente Prudente
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Laís M. Vanzella, Master Degree Student, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT03119493    
Other Study ID Numbers: 53117116000005402
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: I don't have plans
Keywords provided by Laís M. Vanzella, Universidade Estadual Paulista Júlio de Mesquita Filho:
Metabolic syndrome X
Autonomic nervous system
Aerobic exercise
Exercise
Heart rate
Additional relevant MeSH terms:
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Microvascular Angina
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
 Glucose Metabolism Disorders
Metabolic Diseases
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases