Physical Exercise and Energy Balance

September 16, 2019 updated by: Rosely Sichieri, Rio de Janeiro State University

Effect of Physical Exercise Intensity on Spontaneous Physical Activity Energy Expenditure and Energy Intake in Overweight Adults: a Study Protocol for a Randomized Controlled Trial.

This study is a randomized controlled trial, designed to evaluate the effect of structured physical exercise sessions on the spontaneous physical activity energy expenditure and caloric intake in overweight adults. The design employs a parallel three-group experimental arms: (1) a moderate exercise group (MEG); (2) a vigorous exercise group (VEG); and a control group (CG) without physical exercise sessions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20021-010
        • Naval Academy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. male
  2. overweight

Exclusion Criteria:

  1. diabetes mellitus
  2. cardiovascular diseases
  3. musculoskeletal injuries

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
without physical exercise sessions
Experimental: Moderate exercise group
The training phase of the moderate exercise group (MEG) will consist of 4 sets of 10 minutes walking/running at moderate intensity, with 5 minutes walking at low intensity for recovery between sets
Behavioral: Moderate exercise
The training phase of the moderate exercise group (MEG) will consist of 4 sets of 10 minutes walking/running at moderate intensity, with 5 minutes walking at low intensity for recovery between sets
Experimental: Vigorous exercise group
The training phase of the vigorous exercise group (VEG) will consist of 4 sets of 10 minutes running at vigorous intensity, with 5 minutes walking at low intensity for recovery between sets
Behavioral: Vigorous exercise
The training phase of the vigorous exercise group (VEG) will consist of 4 sets of 10 minutes running at vigorous intensity, with 5 minutes walking at low intensity for recovery between sets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
spontaneous physical activity energy expenditure
Time Frame: 15 days
Physical activity energy expenditure will be assessed by a triaxial accelerometers (ActiGraph GT3x-BT, Pensacola, FL, USA). The device will be positioned at the anterior axillary line of the non-dominant hip, for 15 consecutive days
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
appetite sensations
Time Frame: 15 days
Subjective hunger and satiety sensations will be measured through the visual analog scale (VAS) proposed by Flint et al. (2000).
15 days
energy intake
Time Frame: 15 days
Food and beverages consumption will be assessed by 24-h food recalls (REC24h). Nutritionists will conduct a face-to-face interview in four different moments during the intervention period: at the 2nd and 5th days (Tuesday and Friday) in the first week; and at the 11th and 15th days (Thursday and Monday) in the second week, including weekdays and weekend.
15 days
laboratorial biomarkers
Time Frame: 15 days
To investigate the physiological mechanisms involved in energy expenditure and food consumption regulation, blood and salivary samples will be collected to biochemical and hormonal analyses at the 1st (baseline) and the 15th days of the intervention period, in the morning, after at least 10 hours of fasting.
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rio de Janeiro State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

June 15, 2018

Study Completion (Actual)

June 15, 2018

Study Registration Dates

First Submitted

April 30, 2017

First Submitted That Met QC Criteria

April 30, 2017

First Posted (Actual)

May 3, 2017

Study Record Updates

Last Update Posted (Actual)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 16, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • exercise and obesity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Physical Activity

Clinical Trials on Moderate exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe