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Periodized Aerobic Interval Training in Metabolic Syndrome

Primary Purpose

Metabolic Syndrome, Metabolic Syndrome X

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Periodized 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 Metabolic syndrome X, Autonomic nervous system, Aerobic exercise, Exercise, Heart rate

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Laís Manata Vanzella

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Periodized aerobic interval training

Control group

Arm Description

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]

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

Outcomes

Primary Outcome Measures

Heart rate variability

Secondary Outcome Measures

Cardiovascular parameter : heart rate
Cardiovascular parameter: blood pressure
Anthropometric parameter: hit waist ratio
Anthropometric parameter: abdominal circumference
Anthropometric parameter: body mass index
Measured by weight and height

Full Information

First Posted
April 7, 2017
Last Updated
April 13, 2017
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
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1. Study Identification

Unique Protocol Identification Number
NCT03119493
Brief Title
Periodized Aerobic Interval Training in Metabolic Syndrome
Official Title
Effects of Periodized Aerobic Interval Training on Autonomic Modulation and Cardiovascular and Anthropometric Variables in Individuals With Metabolic Syndrome
Study Type
Interventional

2. Study Status

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

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Metabolic Syndrome X
Keywords
Metabolic syndrome X, Autonomic nervous system, Aerobic exercise, Exercise, Heart rate

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Periodized aerobic interval training
Arm Type
Experimental
Arm Description
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]
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in the control group will be instructed not to take part in any regular exercise programs during the study period.
Intervention Type
Behavioral
Intervention Name(s)
Periodized aerobic interval training
Intervention Description
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).
Primary Outcome Measure Information:
Title
Heart rate variability
Time Frame
16 week after allocation
Secondary Outcome Measure Information:
Title
Cardiovascular parameter : heart rate
Time Frame
16 week after allocation
Title
Cardiovascular parameter: blood pressure
Time Frame
16 week after allocation
Title
Anthropometric parameter: hit waist ratio
Time Frame
16 week after allocation
Title
Anthropometric parameter: abdominal circumference
Time Frame
16 week after allocation
Title
Anthropometric parameter: body mass index
Description
Measured by weight and height
Time Frame
16 week after allocation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Metabolic syndrome according to international diabetes federation (IDF) definition Aged between 40 to 60 years Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luiz Carlos M Vanderlei, PHD
Organizational Affiliation
Universidade Estadual Paulista - UNESP campus de Presidente Prudente
Official's Role
Study Director
Facility Information:
Facility Name
Laís Manata Vanzella
City
Presidente Prudente
State/Province
São Paulo
ZIP/Postal Code
19.060-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
I don't have plans
Citations:
PubMed Identifier
30916161
Citation
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.
Results Reference
derived

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Periodized Aerobic Interval Training in Metabolic Syndrome

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