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The Effect of Combined Aerobic Exercise and Calorie Restriction on Mood, Cognition, and Motor Behavior in Overweight and Obese Women

Primary Purpose

Obesity, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
aerobic exercise plus calorie restriction
Sponsored by
Lithuanian Sports University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring brain activity, cognitive function, diet, exercise, motor behavior, psychosocial state

Eligibility Criteria

35 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Laura Zlibinaite

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

aerobic exercise plus calorie restriction

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Weight
weight (TBF-300 body composition scale; Tanita, UK Ltd., UK) was measured while the participants wore only underwear and were barefoot.
mood state
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."
Blood brain-derived neurotrophic factor (BDNF)
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).
Height
Body height was measured in meters with an accuracy of 5 mm
Cognitive functions
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.
prefrontal cortex activity
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.
psychomotor function
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.

Secondary Outcome Measures

Changes in body weight
weight (TBF-300 body composition scale; Tanita, UK Ltd., UK) was measured while the participants wore only underwear and were barefoot.
Changes in mood state
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."
changes in blood brain-derived neurotrophic factor (BDNF)
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).
Improvement of cognitive functions
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.
Changes in prefrontal cortex activity
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.
Improvement of psychomotor function
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.

Full Information

First Posted
July 9, 2019
Last Updated
December 9, 2019
Sponsor
Lithuanian Sports University
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1. Study Identification

Unique Protocol Identification Number
NCT04016909
Brief Title
The Effect of Combined Aerobic Exercise and Calorie Restriction on Mood, Cognition, and Motor Behavior in Overweight and Obese Women
Official Title
The Effect of Combined Aerobic Exercise and Calorie Restriction on Mood, Cognition, and Motor Behavior in Overweight and Obese Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
June 15, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lithuanian Sports University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The benefits of weight-loss programs on mood state and cognitive and motor behavior remain unclear and are largely limited to those of calorie restriction (CR) or physical exercise alone. Our aim was to investigate the effect of a combined CR and aerobic exercise program on mood state, cognition-related brain activity, and cognitive and motor behavior in overweight and obese women. Twenty-six overweight or obese women were randomized to either a control group (no intervention) or an experimental group (aerobic exercise + 12.5% energy-intake reduction). Brain-derived neurotrophic factor (BDNF) levels, mood, prefrontal cortex activity, cognitive performance, and learning of a speed-accuracy task were evaluated before and 6 months after the beginning of the program. Confusion and depression increased in the control group (P < 0.05), whereas tension decreased in the experimental group (P < 0.05). BDNF level and learning of a speed-accuracy task remained unchanged. Although PFC activity and executive functions were not affected, the reaction time of visual scanning and associative learning were improved in the experimental group (P < 0.05). An improvement in reaction time during the speed-accuracy task was observed (P < 0.05). In conclusion, a 6-month combined CR and aerobic exercise intervention improved the psychosocial mental state of overweight and obese women. Although it improved motor planning during the speed-accuracy task, it had little impact on cognition and no effect on brain activity and learning of the speed-accuracy task.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolic Syndrome
Keywords
brain activity, cognitive function, diet, exercise, motor behavior, psychosocial state

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aerobic exercise plus calorie restriction
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
aerobic exercise plus calorie restriction
Intervention Description
both a 6-month aerobic exercise program (moderate intensity) and caloric restriction (12.5% energy deficit)
Primary Outcome Measure Information:
Title
Weight
Description
weight (TBF-300 body composition scale; Tanita, UK Ltd., UK) was measured while the participants wore only underwear and were barefoot.
Time Frame
baseline
Title
mood state
Description
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."
Time Frame
baseline
Title
Blood brain-derived neurotrophic factor (BDNF)
Description
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).
Time Frame
baseline
Title
Height
Description
Body height was measured in meters with an accuracy of 5 mm
Time Frame
baseline
Title
Cognitive functions
Description
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.
Time Frame
baseline
Title
prefrontal cortex activity
Description
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.
Time Frame
baseline
Title
psychomotor function
Description
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.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Changes in body weight
Description
weight (TBF-300 body composition scale; Tanita, UK Ltd., UK) was measured while the participants wore only underwear and were barefoot.
Time Frame
6 months
Title
Changes in mood state
Description
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."
Time Frame
6 months
Title
changes in blood brain-derived neurotrophic factor (BDNF)
Description
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).
Time Frame
6 months
Title
Improvement of cognitive functions
Description
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.
Time Frame
6 months
Title
Changes in prefrontal cortex activity
Description
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.
Time Frame
6 months
Title
Improvement of psychomotor function
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Laura Zlibinaite
City
Kaunas
ZIP/Postal Code
44221
Country
Lithuania

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Combined Aerobic Exercise and Calorie Restriction on Mood, Cognition, and Motor Behavior in Overweight and Obese Women

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