The Effect of Aerobic Exercise in Overweight and Obese Women

Obesity Clinical Trial

Official title:

The Effect of Aerobic Exercise on Body Composition, Cardiovascular System and Autonomic Stress Response, and Cognition in Overweight and Obese Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04205981
• Other study ID #: LithuanianSportsU-2
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: December 2019
• Source: Lithuanian Sports University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 38 Years to 56 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• Aerobic exercise
8-week aerobic exercise (moderate intensity), 5 times per week, 60 min per session. Exercise training under supervision of trained staff.

Locations

Country	Name	City	State
Lithuania	Lithuanian Sports University	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian Sports University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	weight (TBF-300 body composition scale; Tanita, UK Ltd., UK) was measured while the participants wore only underwear and were barefoot.	8 weeks
Primary	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).	8 weeks
Primary	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.	8 weeks
Primary	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.	8 weeks
Primary	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.	8 weeks
Primary	Resting blood pressure	was measured using a digital electronic blood pressure monitor (Microlife BP A100, Widnau, Switzerland)	8 weeks
Primary	Heart rate variability	R-R intervals were recorded using a Polar H7 sensor with a chest strap (Kempele, Finland).	8 weeks