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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03119493
Other study ID # 53117116000005402
Secondary ID
Status Completed
Phase N/A
First received April 7, 2017
Last updated April 13, 2017
Start date June 1, 2015
Est. completion date December 1, 2016

Study information

Verified date April 2017
Source Universidade Estadual Paulista Júlio de Mesquita Filho
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date December 1, 2016
Est. primary completion date December 1, 2016
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Periodized aerobic interval training
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).

Locations

Country Name City State
Brazil Laís Manata Vanzella Presidente Prudente São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Heart rate variability 16 week after allocation
Secondary Cardiovascular parameter : heart rate 16 week after allocation
Secondary Cardiovascular parameter: blood pressure 16 week after allocation
Secondary Anthropometric parameter: hit waist ratio 16 week after allocation
Secondary Anthropometric parameter: abdominal circumference 16 week after allocation
Secondary Anthropometric parameter: body mass index Measured by weight and height 16 week after allocation
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