Sedentary Behavior Breaks With Isometric Exercise in Cardiovascular Health Indicators

Sedentary Behavior Clinical Trial

— BREAK001  

Official title:

Effects of Breaks of Sedentary Behavior With Isometric Exercise in Cardiovascular Health Indicators of Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03949205
• Other study ID #: BREAK001
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Sedentary Behavior

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