- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03119493
Periodized Aerobic Interval Training in Metabolic Syndrome
April 13, 2017 updated by: Laís M. Vanzella, Universidade Estadual Paulista Júlio de Mesquita Filho
Effects of Periodized Aerobic Interval Training on Autonomic Modulation and Cardiovascular and Anthropometric Variables in Individuals With Metabolic Syndrome
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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São Paulo
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Presidente Prudente, São Paulo, Brazil, 19.060-900
- Laís Manata Vanzella
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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
40 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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 |
|---|---|
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Experimental: Periodized aerobic interval training
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]
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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).
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No Intervention: Control group
Participants in the control group will be instructed not to take part in any regular exercise programs during the study period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Heart rate variability
Time Frame: 16 week after allocation
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16 week after allocation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cardiovascular parameter : heart rate
Time Frame: 16 week after allocation
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16 week after allocation
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Cardiovascular parameter: blood pressure
Time Frame: 16 week after allocation
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16 week after allocation
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Anthropometric parameter: hit waist ratio
Time Frame: 16 week after allocation
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16 week after allocation
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Anthropometric parameter: abdominal circumference
Time Frame: 16 week after allocation
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16 week after allocation
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Anthropometric parameter: body mass index
Time Frame: 16 week after allocation
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Measured by weight and height
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16 week after allocation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Luiz Carlos M Vanderlei, PhD, Universidade Estadual Paulista - UNESP campus de Presidente Prudente
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
April 7, 2017
First Submitted That Met QC Criteria
April 13, 2017
First Posted (Actual)
April 18, 2017
Study Record Updates
Last Update Posted (Actual)
April 18, 2017
Last Update Submitted That Met QC Criteria
April 13, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 53117116000005402
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
I don't have plans
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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