NCT03036332

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

1.5 years

First QC Date

January 26, 2017

Last Update Submit

January 27, 2017

Conditions

Metabolic Syndrome

Keywords

aerobic interval trainingbiomarkers

Outcome Measures

Primary Outcomes (1)

  • Pro-inflammatory marker

    Serum levels of C-reactive protein

    16 weeks

Secondary Outcomes (2)

  • Quality of life

    16 weeks

  • A set of clinical biomarkers

    16 weeks

Study Arms (2)

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

Aerobic interval trainingBEHAVIORAL

Carried out 3 times per week for 16 weeks

intervention

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Rodolfo AT Miranda, Me

    Universidade Estadual Paulista Júlio de Mesquita

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr. Rodolfo Augusto Travagin Miranda

Study Record Dates

First Submitted

January 26, 2017

First Posted

January 30, 2017

Study Start

June 1, 2015

Primary Completion

December 10, 2016

Study Completion

December 10, 2016

Last Updated

January 30, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share