ObesityNCT04205981
The Effect of Aerobic Exercise in Overweight and Obese Women
A study testing Aerobic exercise in people with Obesity and Overweight, run by Lithuanian Sports University at 1 site in Lithuania.
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. Read more about this study
- Who is it for?
- Ages 38 to 56 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Sep 2017to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 to 56 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Aerobic Exercise on Body Composition, Cardiovascular System and Autonomic Stress Response, and Cognition 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.
- Conditions
- Obesity, Overweight
- Being tested
- Aerobic exercise
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
8-week aerobic exercise (moderate intensity), 5 times per week, 60 min per session. Exercise training under supervision of trained staff.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | 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. Receives: Other: Aerobic exercise |
| Control | No intervention | . 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
weight (TBF-300 body composition scale; Tanita, UK Ltd., UK) was measured while the participants wore only underwear and were barefoot.
Measured: 8 weeks
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).
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Resting blood pressure
was measured using a digital electronic blood pressure monitor (Microlife BP A100, Widnau, Switzerland)
Measured: 8 weeks
Heart rate variability
R-R intervals were recorded using a Polar H7 sensor with a chest strap (Kempele, Finland).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start1 Sep 2017
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian Sports University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205981
- Sponsor's protocol ID
- LithuanianSportsU-2
- Status last verified
- Dec 2019
- First submitted
- 18 Dec 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aerobic Exercise on Body Composition, Cardiovascular System and Autonomic Stress Response, and Cognition in Overweight and Obese Women
- ClinicalTrials.gov ID
- NCT04205981
- Acronym / sponsor ID
- LithuanianSportsU-2
- Conditions
- Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Lithuanian Sports UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Other: Aerobic exerciseExercise 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. |
| Control | No intervention | –. 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. |
Who may qualify
- Ages
- 38 to 56 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise8-week aerobic exercise (moderate intensity), 5 times per week, 60 min per session. Exercise training under supervision of trained staff. | Other | Aerobic exercise |
Primary outcome
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.
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).
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.
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.
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.
Resting blood pressure
Time frame: 8 weeks
was measured using a digital electronic blood pressure monitor (Microlife BP A100, Widnau, Switzerland)
Heart rate variability
Time frame: 8 weeks
R-R intervals were recorded using a Polar H7 sensor with a chest strap (Kempele, Finland).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Obesity and Overweight, run by Lithuanian Sports University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 8 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.