Physical Exercise and Energy Balance

Not Applicable

Completed

• Conditions: Physical Activity
• Interventions: Behavioral: Moderate exercise; Behavioral: Vigorous exercise

• Registration Number: NCT03138187
• Lead Sponsor: Rio de Janeiro State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-30
• Study First Submitted QC: 2017-04-30
• Study First Posted: 2017-05-03
• Study Start: 2017-06-01
• Primary Completion: 2018-06-15
• Study Completion: 2018-06-15
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-16
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 72

Inclusion Criteria

1. male
2. overweight

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate exercise group	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
Vigorous exercise group	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

Primary Outcome Measures

Name	Time	Method
spontaneous physical activity energy expenditure	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

Secondary Outcome Measures

Name	Time	Method
laboratorial biomarkers	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.
appetite sensations	15 days	Subjective hunger and satiety sensations will be measured through the visual analog scale (VAS) proposed by Flint et al. (2000).
energy intake	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.

Trial Locations

Locations (1)

Naval Academy; 🇧🇷 Rio de Janeiro, Brazil