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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03036332
Other study ID # RATMiranda1
Secondary ID
Status Completed
Phase N/A
First received January 26, 2017
Last updated January 27, 2017
Start date June 1, 2015
Est. completion date December 10, 2016

Study information

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

Clinical Trial 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.


Description:

Besides the traditional metabolic syndrome risk factors (dyslipidemia, raised blood pressure, central obesity and dysglycemia) subclinical disorders related to chronic inflammation and cell damage have been reported on metabolic syndrome. Therefore, regarding the systemic feature of metabolic syndrome, we investigated an new approach of aerobic interval training on several clinical biomarkers widely used. Such training used differs from current aerobic protocols in order to attenuate metabolic and musculoskeletal overload on untrained and unhealthy subjects.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date December 10, 2016
Est. primary completion date December 10, 2016
Accepts healthy volunteers No
Gender All
Age group 35 Years to 60 Years
Eligibility Inclusion Criteria:

- Having metabolic syndrome according to international diabetes foundations definition (IDF).

- Age between 35 - 60 years and untrained subjects.

Exclusion Criteria:

- 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).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Aerobic interval training
Carried out 3 times per week for 16 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

Outcome

Type Measure Description Time frame Safety issue
Primary Pro-inflammatory marker Serum levels of C-reactive protein 16 weeks
Secondary Quality of life The Medical Outcomes Study-Short Form 36 (SF-36) 16 weeks
Secondary A set of clinical biomarkers Serum levels lof Homocysteine; Creatinine, Creatine kinase (ck); creatine kinase MB (ck-mb); Troponin t; aspartate aminotransferase; alanine aminotransferase; and complete blood count. 16 weeks
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