Exercise Training and Metabolic Syndrome | NCT03036332

Studies
Exercise Training and Metabolic Syndrome

NCT03036332

Sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Status

Completed

Last Update Posted

Jan 30, 2017Estimated

Enrollment

53Actual

Phase

Not Applicable

Conditions

Metabolic Syndrome

Interventions

Aerobic interval training

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2015Actual

Primary Completion Date

Dec 10, 2016Actual

Completion Date

Dec 10, 2016Actual

First Submitted Date

Jan 26, 2017

First Submission Date that Met QC Criteria

Jan 27, 2017

First Posted Date

Jan 30, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2017

Last Update Posted Date

Jan 30, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rodolfo Augusto Travagin Miranda, Mr. Rodolfo Augusto Travagin Miranda, Universidade Estadual Paulista Júlio de Mesquita FilhoPrincipal Investigator

Lead Sponsor

Universidade Estadual Paulista Júlio de Mesquita FilhoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention	Experimental	Aerobic interval training	Behavioral: Aerobic interval training
Control group	No Intervention	The participants performed only initial evaluation and at the end of the study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aerobic interval training	Behavioral	Carried out 3 times per week for 16 weeks	intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rodolfo AT Miranda, Me	Universidade Estadual Paulista Júlio de Mesquita	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome

Ancestor Terms

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided