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Completed

NCT Number: NCT03138187

Physical Exercise and Energy Balance

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.

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Key information

Conditions

Physical Activity Behavior Motor Activity

Age range

18 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Naval Academy

Rio de Janeiro, 20021-010, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male
  • overweight

Exclusion criteria

  • diabetes mellitus
  • cardiovascular diseases
  • musculoskeletal injuries

Treatment and study plan

moderate exercise

Behavioral

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

Behavioral

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 outcomes

  1. 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

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Rio de Janeiro State University

Other

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 3, 2017
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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