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Completed

NCT Number: NCT04205981

The Effect of Aerobic Exercise in Overweight and Obese Women

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

38 year–56 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lithuanian Sports University

Kaunas, Lithuania

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic Exercise

Other

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

Primary outcomes

  1. Weight

    Time frame: 8 weeks

    weight (TBF-300 body composition scale; Tanita, UK Ltd., UK) was measured while the participants wore only underwear and were barefoot.

  2. Blood brain-derived neurotrophic factor (BDNF)

    Time frame: 8 weeks

    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).

  3. Cognitive performance

    Time frame: 8 weeks

    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.

  4. Maximal oxygen uptake

    Time frame: 8 weeks

    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.

  5. Waist and hip circumference

    Time frame: 8 weeks

    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.

  6. Resting blood pressure

    Time frame: 8 weeks

    was measured using a digital electronic blood pressure monitor (Microlife BP A100, Widnau, Switzerland)

  7. Heart rate variability

    Time frame: 8 weeks

    R-R intervals were recorded using a Polar H7 sensor with a chest strap (Kempele, Finland).

Sponsors and collaborators

Lead sponsor

Lithuanian Sports University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2019
Registry last updated
Dec 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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