Physical Exercise and Energy Balance

Physical Activity Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03138187
• Other study ID #: exercise and obesity
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: June 15, 2018

Study information

• Verified date: September 2019
• Source: Rio de Janeiro State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

1. male

2. overweight

Exclusion Criteria:

1. diabetes mellitus

2. cardiovascular diseases

3. musculoskeletal injuries

Related Conditions & MeSH terms

• Physical Activity

Intervention

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
• 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

Locations

Country	Name	City	State
Brazil	Naval Academy	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Rio de Janeiro State University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	appetite sensations	Subjective hunger and satiety sensations will be measured through the visual analog scale (VAS) proposed by Flint et al. (2000).	15 days
Secondary	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
Secondary	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