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.
Verified date | September 2019 |
Source | Rio de Janeiro State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Naval Academy | Rio de Janeiro |
Lead Sponsor | Collaborator |
---|---|
Rio de Janeiro State University |
Brazil,
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 |
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