Sedentary Behavior Breaks With Isometric Exercise in Cardiovascular Health Indicators

NCT03949205 | Completed DMC

• 1 other identifier: BREAK001
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sedentary Behavior

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes from baseline in blood pressure at 12 weeks

  Baseline and 12 weeks

• Change from baseline in cardiac autonomic modulation at 12 weeks

  Baseline and 12 weeks

Study Arms (2)

Leg Extension Isometric Training

EXPERIMENTAL

Experimental group will perform leg extension isometric exercise.

Other: Leg Extension Isometric Training

Control Group

NO INTERVENTION

Control group will be advised to maintain their work habits and not to change their routine activities, especially diet and physical activities.

Interventions

Leg Extension Isometric Training OTHER

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.

Leg Extension Isometric Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Adherence to the training sessions inferior to 85%
• Adherence to another supervised exercise program
• Change the characteristics of the occupational activities

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Universidade Nove de Julho

São Paulo, 01504-001, Brazil

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Raphael Ritti-Dias, PhD

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled trial and randomized crossover trial.

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 14, 2019
• Study Start: May 13, 2019
• Primary Completion: December 30, 2020
• Study Completion: February 20, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 1 year after the end of recruitment.

Locations

BR (1)