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Exercise Training and Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aerobic interval training
Sponsored by
Universidade Estadual Paulista Júlio de Mesquita Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring aerobic interval training, biomarkers

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    intervention

    Control group

    Arm Description

    Aerobic interval training

    The participants performed only initial evaluation and at the end of the study

    Outcomes

    Primary Outcome Measures

    Pro-inflammatory marker
    Serum levels of C-reactive protein

    Secondary Outcome Measures

    Quality of life
    The Medical Outcomes Study-Short Form 36 (SF-36)
    A set of clinical biomarkers
    Serum levels lof Homocysteine; Creatinine, Creatine kinase (ck); creatine kinase MB (ck-mb); Troponin t; aspartate aminotransferase; alanine aminotransferase; and complete blood count.

    Full Information

    First Posted
    January 26, 2017
    Last Updated
    January 27, 2017
    Sponsor
    Universidade Estadual Paulista Júlio de Mesquita Filho
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03036332
    Brief Title
    Exercise Training and Metabolic Syndrome
    Official Title
    Effects of Aerobic Interval Training on Clinical Biomarkers and Quality of Life in Metabolic Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2015 (Actual)
    Primary Completion Date
    December 10, 2016 (Actual)
    Study Completion Date
    December 10, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Estadual Paulista Júlio de Mesquita Filho

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome
    Keywords
    aerobic interval training, biomarkers

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    53 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention
    Arm Type
    Experimental
    Arm Description
    Aerobic interval training
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    The participants performed only initial evaluation and at the end of the study
    Intervention Type
    Behavioral
    Intervention Name(s)
    Aerobic interval training
    Intervention Description
    Carried out 3 times per week for 16 weeks
    Primary Outcome Measure Information:
    Title
    Pro-inflammatory marker
    Description
    Serum levels of C-reactive protein
    Time Frame
    16 weeks
    Secondary Outcome Measure Information:
    Title
    Quality of life
    Description
    The Medical Outcomes Study-Short Form 36 (SF-36)
    Time Frame
    16 weeks
    Title
    A set of clinical biomarkers
    Description
    Serum levels lof Homocysteine; Creatinine, Creatine kinase (ck); creatine kinase MB (ck-mb); Troponin t; aspartate aminotransferase; alanine aminotransferase; and complete blood count.
    Time Frame
    16 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rodolfo AT Miranda, Me
    Organizational Affiliation
    Universidade Estadual Paulista Júlio de Mesquita
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Exercise Training and Metabolic Syndrome

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