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

December 9, 2019 updated by: Lithuanian Sports University
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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kaunas, Lithuania, 44221
        • Laura Zlibinaite

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

June 15, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

July 9, 2019

First Submitted That Met QC Criteria

July 9, 2019

First Posted (Actual)

July 12, 2019

Study Record Updates

Last Update Posted (Actual)

December 10, 2019

Last Update Submitted That Met QC Criteria

December 9, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on aerobic exercise plus calorie restriction

Subscribe