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Physical Exercise and Energy Balance

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03138187
Enrollment
72
Registered
2017-05-03
Start date
2017-06-01
Completion date
2018-06-15
Last updated
2019-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Activity

Keywords

spontaneous physical activity, caloric intake

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.

Interventions

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

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

Sponsors

Rio de Janeiro State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Participants and physical trainer blinding will not be feasible due to the characteristics of prescribed exercise sessions. However, the evaluators will be blinded to the following endpoints: weight, body composition, appetite, energy intake and laboratorial biomarkers.

Eligibility

Sex/Gender
MALE
Age
18 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

1. male 2. overweight

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
spontaneous physical activity energy expenditure15 daysPhysical 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

MeasureTime frameDescription
appetite sensations15 daysSubjective hunger and satiety sensations will be measured through the visual analog scale (VAS) proposed by Flint et al. (2000).
energy intake15 daysFood 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.
laboratorial biomarkers15 daysTo 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026