Exercise Training and Metabolic Syndrome

January 27, 2017 updated by: Rodolfo Augusto Travagin Miranda, Universidade Estadual Paulista Júlio de Mesquita Filho

Effects of Aerobic Interval Training on Clinical Biomarkers and Quality of Life in Metabolic Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pro-inflammatory marker
Time Frame: 16 weeks
Serum levels of C-reactive protein
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 16 weeks
The Medical Outcomes Study-Short Form 36 (SF-36)
16 weeks
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.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Investigators

  • Principal Investigator: Rodolfo AT Miranda, Me, Universidade Estadual Paulista Júlio de Mesquita

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

December 10, 2016

Study Completion (Actual)

December 10, 2016

Study Registration Dates

First Submitted

January 26, 2017

First Submitted That Met QC Criteria

January 27, 2017

First Posted (Estimate)

January 30, 2017

Study Record Updates

Last Update Posted (Estimate)

January 30, 2017

Last Update Submitted That Met QC Criteria

January 27, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RATMiranda1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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