Physical Exercise and Energy Balance

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Physical Activity

Intervention / Treatment
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* Behavioral: Moderate exercise
* Behavioral: Vigorous exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male overweight Exclusion Criteria: diabetes mellitus cardiovascular diseases musculoskeletal injuries

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>without physical exercise sessions | |
| Experimental: Moderate exercise group<br>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<br>* 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<br>|
| Experimental: Vigorous exercise group<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spontaneous physical activity energy expenditure | 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 | Subjective hunger and satiety sensations will be measured through the visual analog scale (VAS) proposed by Flint et al. (2000). | 15 days | 
| energy intake | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spontaneous physical activity, caloric intake