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Exercise Training and Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT03036332
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
Rodolfo Augusto Travagin Miranda, Universidade Estadual Paulista Júlio de Mesquita Filho

Brief Summary:
The present study aimed to determine the effects of 16 weeks of aerobic interval training on quality of life and a set of clinical biomarkers.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Behavioral: Aerobic interval training Not Applicable

Detailed Description:
Besides the traditional metabolic syndrome risk factors (dyslipidemia, raised blood pressure, central obesity and dysglycemia) subclinical disorders related to chronic inflammation and cell damage have been reported on metabolic syndrome. Therefore, regarding the systemic feature of metabolic syndrome, we investigated an new approach of aerobic interval training on several clinical biomarkers widely used. Such training used differs from current aerobic protocols in order to attenuate metabolic and musculoskeletal overload on untrained and unhealthy subjects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Aerobic Interval Training on Clinical Biomarkers and Quality of Life in Metabolic Syndrome
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : December 10, 2016
Actual Study Completion Date : December 10, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intervention
Aerobic interval training
Behavioral: Aerobic interval training
Carried out 3 times per week for 16 weeks

No Intervention: Control group
The participants performed only initial evaluation and at the end of the study



Primary Outcome Measures :
  1. Pro-inflammatory marker [ Time Frame: 16 weeks ]
    Serum levels of C-reactive protein


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 16 weeks ]
    The Medical Outcomes Study-Short Form 36 (SF-36)

  2. A set of clinical biomarkers [ Time Frame: 16 weeks ]
    Serum levels lof Homocysteine; Creatinine, Creatine kinase (ck); creatine kinase MB (ck-mb); Troponin t; aspartate aminotransferase; alanine aminotransferase; and complete blood count.



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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having metabolic syndrome according to international diabetes foundations definition (IDF).
  • Age between 35 - 60 years and untrained subjects.

Exclusion Criteria:

  • Musculotendinous or osteoarticular injuries in the lower limbs and/or spine
  • Chronic pulmonary diseases
  • Neurological disorders
  • Kidney failure
  • High-risk cardiovascular diseases (Unstable angina pectoris, Uncompensated heart failure, complex ventricular arrhythmias or myocardial infarction during the last month).

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): NCT03036332


Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Investigators
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Principal Investigator: Rodolfo AT Miranda, Me Universidade Estadual Paulista Júlio de Mesquita

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Responsible Party: Rodolfo Augusto Travagin Miranda, Mr. Rodolfo Augusto Travagin Miranda, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT03036332     History of Changes
Other Study ID Numbers: RATMiranda1
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rodolfo Augusto Travagin Miranda, Universidade Estadual Paulista Júlio de Mesquita Filho:
aerobic interval training
biomarkers

Additional relevant MeSH terms:
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Syndrome
Metabolic Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases