Clinical trial NCT03949205: Sedentary Behavior Breaks With Isometric Exercise in Cardiovascular Health Indicators
Official title: Effects of Breaks of Sedentary Behavior With Isometric Exercise in Cardiovascular Health Indicators of Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Behavior
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial and randomized crossover trial.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in vascular function at 12 weeks
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Changes from baseline in blood pressure at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline in cardiac autonomic modulation at 12 weeks
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Nove de Julho
Study officials:
affiliation: University of Nove de Julho
name: Raphael Ritti-Dias, PhD
role: PRINCIPAL_INVESTIGATOR
References: