- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04016909
The Effect of Combined Aerobic Exercise and Calorie Restriction on Mood, Cognition, and Motor Behavior in Overweight and Obese Women
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kaunas, Lithuania, 44221
- Laura Zlibinaite
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- gender: female;
- body mass index (BMI) greater than 25 kg/m2;
- exhibiting weight stability (body weight change <2 kg) for at least 2 months prior to enrollment;
- sedentary lifestyle (regular exercise 1 h/week).
Exclusion Criteria:
- undergoing lactation;
- pregnant or postmenopausal;
- type 2 diabetes;
- cardiovascular disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: aerobic exercise plus calorie restriction
The experimental intervention: both exercise and calorie restriction, as described below: Exercise intervention. 6 months, 72 supervised aerobic exercise training sessions on cycle ergometers, including 3 sessions of training per week. A warm-up procedure consisting of 5 min of low-intensity stretching was completed by all women before the aerobic training. Subsequently, a 50 min aerobic training at an intensity between 60% and 70% of the maximum heart rate (HR) was performed. Thereafter, a cool-down consisting of 5 min of low-intensity stretching and breathing exercises was completed. HR was recorded continuously throughout the training sessions using an HR monitor (S625X, Polar Electro, Kempele, Finland). Calorie restriction intervention. The CR intervention was designed to create a 12.5% energy deficit, with the goal of reducing body weight by 5%-10% over 6 months. |
both a 6-month aerobic exercise program (moderate intensity) and caloric restriction (12.5% energy deficit)
|
|
No Intervention: Control
No intervention and participants were instructed to maintain their regular physical activity and diet regime for 6 months; they were also prohibited from participating in any weight-loss or exercise program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight
Time Frame: baseline
|
weight (TBF-300 body composition scale; Tanita, UK Ltd., UK) was measured while the participants wore only underwear and were barefoot.
|
baseline
|
|
mood state
Time Frame: baseline
|
Mood was assessed using the 24-item Brunel Mood Scale, which estimates anger, confusion, depression, fatigue, tension, and vigor.
Items are rated on a 5-point Likert scale anchored by 0 (not at all) and 4 (extremely), according to how participants feel "right now."
|
baseline
|
|
Blood brain-derived neurotrophic factor (BDNF)
Time Frame: baseline
|
Venous blood samples (5 mL) were collected and allowed to clot at room temperature.
Serum was then separated by centrifugation for 15 min at 1,200 g (room temperature) and stored at -80°C until analysis.
BDNF were measured using an enzyme-linked immunoassay system (Gemini; Stratec Biomedical, Birkenfeld, Germany).
|
baseline
|
|
Height
Time Frame: baseline
|
Body height was measured in meters with an accuracy of 5 mm
|
baseline
|
|
Cognitive functions
Time Frame: baseline
|
Automated Neuropsychological Assessment Metrics Version 4 (ANAM-4; Vista Life, USA) was used to measure neurocognitive skills: motor reaction time, mental flexibility, mathematical processing, working memory, visual scanning and associative learning skills.
Participants were familiarized with the test battery twice before the experiments.
|
baseline
|
|
prefrontal cortex activity
Time Frame: baseline
|
Assessment of brain activity was performed on a continuous wave system (fNIR Imager 1100, fNIR Devices LLC, Potomac, MA, United States) using a flexible 16 optode probe set.
The sensor has a temporal resolution of 500 ms per scan with a 2.5 cm source-detector separation allowing for approximately 1.25 cm penetration depth and 16 measurement locations on a rectangular grid covering the forehead region, designed to observe dorsal and inferior frontal cortical areas.
|
baseline
|
|
psychomotor function
Time Frame: baseline
|
During the speed-accuracy task, the participant was required to position the handle symbol (0.0035 m in diameter) in the start zone on the computer screen.
The participant then had to react to the target (a green circle, 0.007 m in diameter) on the computer screen as fast as possible and to push the handle of the device so that the circle of the handle symbol reached the target as quickly and accurately as possible.
The distance from the start zone to the target was 0.17 m.
The endpoint of the movement was reached when the center of the handle symbol stopped in the circle and stayed there for at least 0.02 s.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in body weight
Time Frame: 6 months
|
weight (TBF-300 body composition scale; Tanita, UK Ltd., UK) was measured while the participants wore only underwear and were barefoot.
|
6 months
|
|
Changes in mood state
Time Frame: 6 months
|
Mood was assessed using the 24-item Brunel Mood Scale, which estimates anger, confusion, depression, fatigue, tension, and vigor.
Items are rated on a 5-point Likert scale anchored by 0 (not at all) and 4 (extremely), according to how participants feel "right now."
|
6 months
|
|
changes in blood brain-derived neurotrophic factor (BDNF)
Time Frame: 6 months
|
Venous blood samples (5 mL) were collected and allowed to clot at room temperature.
Serum was then separated by centrifugation for 15 min at 1,200 g (room temperature) and stored at -80°C until analysis.
BDNF were measured using an enzyme-linked immunoassay system (Gemini; Stratec Biomedical, Birkenfeld, Germany).
|
6 months
|
|
Improvement of cognitive functions
Time Frame: 6 months
|
Automated Neuropsychological Assessment Metrics Version 4 (ANAM-4; Vista Life, USA) was used to measure neurocognitive skills: motor reaction time, mental flexibility, mathematical processing, working memory, visual scanning and associative learning skills.
Participants were familiarized with the test battery twice before the experiments.
|
6 months
|
|
Changes in prefrontal cortex activity
Time Frame: 6 months
|
Assessment of brain activity was performed on a continuous wave system (fNIR Imager 1100, fNIR Devices LLC, Potomac, MA, United States) using a flexible 16 optode probe set.
The sensor has a temporal resolution of 500 ms per scan with a 2.5 cm source-detector separation allowing for approximately 1.25 cm penetration depth and 16 measurement locations on a rectangular grid covering the forehead region, designed to observe dorsal and inferior frontal cortical areas.
|
6 months
|
|
Improvement of psychomotor function
Time Frame: 6 months
|
During the speed-accuracy task, the participant was required to position the handle symbol (0.0035 m in diameter) in the start zone on the computer screen.
The participant then had to react to the target (a green circle, 0.007 m in diameter) on the computer screen as fast as possible and to push the handle of the device so that the circle of the handle symbol reached the target as quickly and accurately as possible.
The distance from the start zone to the target was 0.17 m.
The endpoint of the movement was reached when the center of the handle symbol stopped in the circle and stayed there for at least 0.02 s.
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LithuanianSportsU-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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