Sedentary Behavior Breaks With Isometric Exercise in Cardiovascular Health Indicators (BREAK001)

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

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.

Study Overview

• Status: Completed
• Conditions: Sedentary Behavior
• Intervention / Treatment: Other: Leg Extension Isometric Training

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01504-001
    • Universidade Nove de Julho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Leg Extension Isometric Training; Experimental group will perform leg extension isometric exercise.	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.
No Intervention: Control Group; Control group will be advised to maintain their work habits and not to change their routine activities, especially diet and physical activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Investigators: Principal Investigator: Raphael Ritti-Dias, PhD, University of Nove de Julho

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2019
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): February 20, 2021

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: BREAK001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: We plan to share the data upon requirement.
• IPD Sharing Time Frame: 1 year after the end of recruitment.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No