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The Effect of Aerobic Exercise in Overweight and Obese Women

Primary Purpose

Obesity, Overweight

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

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

38 Years - 56 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. obese women (BMI) > 25 kg/m2;
  2. exhibiting weight stability (body weight change < 2 kg) for at least 2 months prior to enrollment;
  3. with a sedentary lifestyle (regular exercise < 1 h/week);
  4. had no medical condition that would affect study results and limit physical activity;
  5. not undergoing lactation;
  6. who were not pregnant or postmenopausal.

Sites / Locations

  • Lithuanian Sports University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Aerobic exercise

Control

Arm Description

Exercise intervention. The experimental group increased their energy expenditure according to American College of Sports Medicine and WHO-based physical activity recommendations for all adults to promote clinically significant weight loss and for additional health benefits: 300 min of moderate-intensity aerobic training throughout the week (WHO, 2010; Swift et al. 2014). Participants underwent five 60 min moderate-intensity cycling sessions per week for a period of 8 weeks, 40 sessions in total. Each session involved 5 min of warm up at 40 Watts, cycling for 50 min at a speed that increased their HR to a target HR obtained at 50-60% of peak VO2, and a 5 min of cool down at 40 Watts.

. In the control group, participants did not undergo any intervention and were instructed to maintain their regular physical activity and diet regime for 8 weeks.

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.
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).
Cognitive performance
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.
Maximal oxygen uptake
Aerobic fitness was assessed by a graded exercise test on an electronically braked cycle ergometer (Ergoselect 100, Ergoline, Bitz, Germany). Standardized verbal encouragement was provided throughout the test to stimulate maximal performance.
Waist and hip circumference
Waist circumference was measured to the nearest 0.1 cm, in duplicate, at the level of the iliac crest at the end of the normal expiration. Hip circumference was measured at the maximum protuberance of the buttocks. Waist and hip circumferences were measured at the nearest 0.5 cm.
Resting blood pressure
was measured using a digital electronic blood pressure monitor (Microlife BP A100, Widnau, Switzerland)
Heart rate variability
R-R intervals were recorded using a Polar H7 sensor with a chest strap (Kempele, Finland).

Secondary Outcome Measures

Full Information

First Posted
December 18, 2019
Last Updated
December 19, 2019
Sponsor
Lithuanian Sports University
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1. Study Identification

Unique Protocol Identification Number
NCT04205981
Brief Title
The Effect of Aerobic Exercise in Overweight and Obese Women
Official Title
The Effect of Aerobic Exercise on Body Composition, Cardiovascular System and Autonomic Stress Response, and Cognition in Overweight and Obese Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 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
Study design The study was designed as a prospective controlled randomized trial. Participants were randomly assigned to one of two groups. In the experimental group, participants (n = 17) received 8-week aerobic exercise intervention without nutrition modifications. In the control group, participants (n = 16) did not undergo any intervention and were instructed to maintain their regular physical activity and diet regime for 8 weeks. Experimental measurements: Anthropometric measurements, Measurement of BDNF, Cardiac autonomic responses, Measurement of aerobic fitness, Measurement of cognitive functions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercise
Arm Type
Experimental
Arm Description
Exercise intervention. The experimental group increased their energy expenditure according to American College of Sports Medicine and WHO-based physical activity recommendations for all adults to promote clinically significant weight loss and for additional health benefits: 300 min of moderate-intensity aerobic training throughout the week (WHO, 2010; Swift et al. 2014). Participants underwent five 60 min moderate-intensity cycling sessions per week for a period of 8 weeks, 40 sessions in total. Each session involved 5 min of warm up at 40 Watts, cycling for 50 min at a speed that increased their HR to a target HR obtained at 50-60% of peak VO2, and a 5 min of cool down at 40 Watts.
Arm Title
Control
Arm Type
No Intervention
Arm Description
. In the control group, participants did not undergo any intervention and were instructed to maintain their regular physical activity and diet regime for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
8-week aerobic exercise (moderate intensity), 5 times per week, 60 min per session. Exercise training under supervision of trained staff.
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
8 weeks
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
8 weeks
Title
Cognitive performance
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
8 weeks
Title
Maximal oxygen uptake
Description
Aerobic fitness was assessed by a graded exercise test on an electronically braked cycle ergometer (Ergoselect 100, Ergoline, Bitz, Germany). Standardized verbal encouragement was provided throughout the test to stimulate maximal performance.
Time Frame
8 weeks
Title
Waist and hip circumference
Description
Waist circumference was measured to the nearest 0.1 cm, in duplicate, at the level of the iliac crest at the end of the normal expiration. Hip circumference was measured at the maximum protuberance of the buttocks. Waist and hip circumferences were measured at the nearest 0.5 cm.
Time Frame
8 weeks
Title
Resting blood pressure
Description
was measured using a digital electronic blood pressure monitor (Microlife BP A100, Widnau, Switzerland)
Time Frame
8 weeks
Title
Heart rate variability
Description
R-R intervals were recorded using a Polar H7 sensor with a chest strap (Kempele, Finland).
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
38 Years
Maximum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: obese women (BMI) > 25 kg/m2; exhibiting weight stability (body weight change < 2 kg) for at least 2 months prior to enrollment; with a sedentary lifestyle (regular exercise < 1 h/week); had no medical condition that would affect study results and limit physical activity; not undergoing lactation; who were not pregnant or postmenopausal.
Facility Information:
Facility Name
Lithuanian Sports University
City
Kaunas
Country
Lithuania

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Aerobic Exercise in Overweight and Obese Women

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