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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03949205
Other study ID # BREAK001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 13, 2019
Est. completion date February 20, 2021

Study information

Verified date September 2021
Source University of Nove de Julho
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to analyze the chronic effects of sedentary behavior breaks using the leg extension isometric exercise in the cardiovascular health indicators of healthy adults exposed to prolonged time in the sitting position. The patients recruited will be randomized into two groups: leg extension isometric training (TIE) and control group (CG). The TIE group will perform 12 weeks of isometric training. The CG will be advised not to change their routine activities, especially diet and physical activities.In the pre and post-intervention periods cardiovascular measures will be obtained.


Description:

Long periods in sedentary behavior promote deterioration of vascular function, which is directly associated with the occurence of chronic noncommunicable diseases. In this context, the execution of interruptions in this behavior (breaks) is recommended. Studies have shown benefits of isometric training in vascular function, which could be useful to minimize the consequences of time spent in sedentary behavior. Thus, the goal of this study is to analyze the chronic effects of sedentary behavior breaks using leg extension isometric exercise in the cardiovascular health indicators of adults exposed to prolonged time in the sitting position. The target population of the study will consist of healthy subjects above 18 years of age of both genders. All subjects will be submitted to measurements of endothelial function, blood pressure and cardiac autonomic modulation. After these measurements, the subjects will be randomized into two groups: leg extension isometric training group (TIE) and control group (CG). After 12 weeks both groups will be submitted to the same measurements from pre-intervention.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date February 20, 2021
Est. primary completion date December 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - No diagnostic of cardiovascular diseases or diabetes - Do not present high cardiovascular risk - Do not participate in an exercise program in the previous six months - Occupational activity that requires more than six hours of sitting time per day - Do not be a smoker or make use of medications Exclusion Criteria: - Adherence to the training sessions inferior to 85% - Adherence to another supervised exercise program - Change the characteristics of the occupational activities

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Leg Extension Isometric Training
The leg extension isometric exercise will be performed tree times a week , in four 2 min bouts of isometric contraction, at a intensity of 30% of maximal voluntary contraction and an interval of two minutes between bouts.

Locations

Country Name City State
Brazil Universidade Nove de Julho São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in vascular function at 12 weeks Vascular function will be measured before and after 12 weeks of intervention on the intervention and control groups by a bidimensional ultrasonography device with spectral Doppler and linear transducer. Baseline and 12 weeks
Secondary Changes from baseline in blood pressure at 12 weeks Blood pressure will be measured before and after 12 weeks of intervention period on intervention and control group by an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan). Baseline and 12 weeks
Secondary Change from baseline in cardiac autonomic modulation at 12 weeks Cardiac autonomic modulation will be measured before and after 12 weeks of intervention period on intervention and control group by heart rate monitor (Polar V800, Polar Electro, Finland). Baseline and 12 weeks
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