NCT03119493

Brief Summary

Autonomic disfunction present in metabolic syndrome subjects is related by a greater vulnerability of the heart and risk of cardiovascular events. In this context, aerobic interval training has been highlighted by its easy applicability and benefits effects in autonomic modulation in different populations. Therefore the studies that use de aerobic interval training in this different populations didn't realize a periodization of training with preparatory periods with progressive increase of load, specific phases with less duration predominating the intensity and transition periods for recuperation. Additionally, there isn't studies that investigate the effects of aerobic interval training in autonomic modulation of individuals with metabolic syndrome. In this context, periodized aerobic interval training can arise like a new type of treatment that offering security and efficacy in subjects with metabolic syndrome. So, the aim of the study is evaluate the effect of periodized aerobic interval training in cardiac autonomic modulation and cardiovascular and anthropometric parameters of individuals with metabolic syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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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 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

1.5 years

First QC Date

April 7, 2017

Last Update Submit

April 13, 2017

Conditions

Keywords

Metabolic syndrome XAutonomic nervous systemAerobic exerciseExerciseHeart rate

Outcome Measures

Primary Outcomes (1)

  • Heart rate variability

    16 week after allocation

Secondary Outcomes (5)

  • Cardiovascular parameter : heart rate

    16 week after allocation

  • Cardiovascular parameter: blood pressure

    16 week after allocation

  • Anthropometric parameter: hit waist ratio

    16 week after allocation

  • Anthropometric parameter: abdominal circumference

    16 week after allocation

  • Anthropometric parameter: body mass index

    16 week after allocation

Study Arms (2)

Periodized aerobic interval training

EXPERIMENTAL

The experimental groups will participate in a 16 week, three times a week based-program of periodized aerobic interval training that consist in warming \[5 minutes of general stretching and 5 minutes of walking on treadmill with heart rate less than 20 percent of heart rate reserve (HHR)\], followed by periodized aerobic interval training on treadmill, and cooling down \[5 minutes of walk in treadmill with a heart rate less than 20 percent of HRR and 5 minutes of rest\]

Behavioral: Periodized aerobic interval training

Control group

NO INTERVENTION

Participants in the control group will be instructed not to take part in any regular exercise programs during the study period.

Interventions

The periodized training program consist in 3 phases: light (I) (training range varying between 20 to 39% of heart rate reserve and active recuperation of 19% of heart rate reserve); moderate (II) (training range varying between 40 to 59% of heart rate reserve and active recuperation of 30% of heart rate reserve) and high (III) (training range varying between 70 to 90 % of heart rate reserve and active recuperation of 50% of heart rate reserve).

Periodized aerobic interval training

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Metabolic syndrome according to international diabetes federation (IDF) definition
  • Aged between 40 to 60 years

You may not qualify if:

  • Participants who are currently participating in any regular exercise programs last six months;
  • Use of drugs or medication (Except for risk factors of metabolic syndrome control);
  • Inflammatory or infectious process;
  • Musculotendinous or osteoarticular injuries in the lower limbs and/or spine;
  • Chronic pulmonary disease;
  • Neurological disorders;
  • Cardiovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laís Manata Vanzella

Presidente Prudente, São Paulo, 19.060-900, Brazil

Location

Related Publications (1)

  • Vanzella LM, Linares SN, Miranda RAT, Silva AKFD, Christofaro DGD, Netto Junior J, Vanderlei LCM. Effects of a new approach of aerobic interval training on cardiac autonomic modulation and cardiovascular parameters of metabolic syndrome subjects. Arch Endocrinol Metab. 2019 Mar-Apr;63(2):148-156. doi: 10.20945/2359-3997000000111. Epub 2019 Mar 21.

MeSH Terms

Conditions

Metabolic SyndromeMotor Activity

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Study Officials

  • Luiz Carlos M Vanderlei, PHD

    Universidade Estadual Paulista - UNESP campus de Presidente Prudente

    STUDY DIRECTOR

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
Master Degree Student

Study Record Dates

First Submitted

April 7, 2017

First Posted

April 18, 2017

Study Start

June 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 18, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

I don't have plans

Locations