Cognitive FunctionBrainFitNCT02915913

Effects of Exercise Training on Cognitive Function and Neurotrophic Factors in Overweight Adults

A study testing Experimental: High Intensity Interval, Resistance training and Plus: High Intensity Interval + Resistance Training in people with Cognitive Function and Motor Activity, run by Universidad Santo Tomas at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The BrainFit Study aims to examine acute effects of High Intensity Interval- vs Resistance or Combined program has benefits on Cognitive Function as well as on secretion and regulation of neurotrophic factors or neurotrophins in a cohort of sedentary, overweight adults (aged 18-30 years) from Bogota, Colombia. Read more about this study

Who is it for?: Ages 18 to 30 years, men onlyHealthy volunteers can take part
Conditions the study is for: Cognitive Function, Motor Activity, Obesity
What is being tested?: Experimental: High Intensity Interval, Resistance training and Plus: High Intensity Interval + Resistance Training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteColombia
Study dates: Sep 2016to Dec 2016
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 18 to 30 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Written informed consent.
Interested in improving health and fitness.
Central obesity: waist circumference ≥90cm
Body mass index ≥ 26 kg/m(2)

Who cannot join

Systemic infections.
Weight loss or gain of >10% of body weight in the past 6 months for any reason.
Currently taking medication that suppresses or stimulates appetite.
Uncontrolled hypertension: systolic blood pressure 160 mm Hg or diastolic blood pressure 95 mm Hg on treatment.
Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
Asthma.

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Diagnosed diabetes (type 1 or 2), fasting impaired glucose tolerance (blood glucose 118 mg/dL), or use of any anti-diabetic medications.
Currently taking antidepressant, steroid, or thyroid medication, unless dosage is stable (no change for 6 months).
Any active use of illegal or illicit drugs.
Current exerciser (>30 min organized exercise per week).
Indication of unsuitability of current health for exercise protocol (PARQ).

Trial locations and contacts

1 site in 1 country.

Colombia1 site

Robinson Ramírez-Vélez
Bogota, Cundinamarca, 000000000

Other trials in Colombia

About this study

Official title: Effects of High Intensity Interval- vs Resistance or Combined- Training for Improving Cognitive Function and Neurotrophic Factors in Overweight Adults (BrainFit Study): Factorial Randomised Controlled Trial

Conditions: Cognitive Function, Motor Activity, Obesity
Being tested: Experimental: High Intensity Interval, Resistance training, Plus: High Intensity Interval + Resistance Training, Non-exercise
Medical subject headings: Motor Activity, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental: High Intensity IntervalBehavioural
Walking on a treadmill 4min at 80-90% peak heart rate and recovery 4 min at 65% peak heart rate until expenditure of 500 kcal
Resistance trainingBehavioural
Completing a resistance circuit (including upper and lower muscle groups) as many times as needed according to subject weight until expenditure of 500 kcal
Plus: High Intensity Interval + Resistance TrainingBehavioural
Walking on a treadmill as intervention 1 until 50% the energy expenditure prescribed is reached, then completing a resistance circuit until 100% energy expenditure is reached
Non-exerciseOther
This group will receive the usual clinical care according to the consensus recommendations of the national goals for cardiovascular health promotion and disease reduction of the American Heart Association and Colombian guidelines COLDEPORTES.

Study groups in NCT02915913
Study group	Role	What they receive
High Intensity Interval	Experimental	One session for 30-60 minutes of high intensity aerobic exercise Receives: Behavioral: Experimental: High Intensity Interval
Resistance training	Experimental	One session for 30-60 minutes of resistance exercise Receives: Behavioral: Resistance training
Plus: High Intensity Interval + Resistance Training	Experimental	One session for 30-60 minutes of high intensity aerobic exercise and resistance exercise Receives: Behavioral: Plus: High Intensity Interval + Resistance Training
Non-exercise	Placebo comparator	Non-exercise Receives: Other: Non-exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline in Brain-derived neurotrophic factor
Measurement of serum Brain-derived neurotropic factor true blood samples.
Measured: Baseline and 60 minutes immediately after the interventions ends

Secondary outcomes (3)

Change from Baseline in Neurotrophin-3
Measured: Baseline and 60 minutes immediately after the interventions ends
Change from Baseline in Neurotrophin-4
Measured: Baseline and 60 minutes immediately after the interventions ends
Change from Baseline change in Cognitive Function
Cognitive Performance Test (BPT) computerized cognitive assessment battery developed by Lumos Labs, Inc.
Measured: Baseline and 60 minutes immediately after the interventions ends

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2016Dec 2016

First posted27 Sep 2016 (estimated)
Study startSep 2016
Primary completionDec 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cognitive FunctionStudies 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: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02915913
Sponsor's protocol ID: 2016-09-22
Acronym: BrainFit
Status last verified: Oct 2018
First submitted: 22 Sep 2016
Last updated: 11 Oct 2018
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

Dominguez-Sanchez MA, Bustos-Cruz RH, Velasco-Orjuela GP, Quintero AP, Tordecilla-Sanders A, Correa-Bautista JE, Triana-Reina HR, Garcia-Hermoso A, Gonzalez-Ruiz K, Pena-Guzman CA, Hernandez E, Pena-Ibagon JC, Tellez-T LA, Izquierdo M, Ramirez-Velez R. Acute Effects of High Intensity, Resistance, or Combined Protocol on the Increase of Level of Neurotrophic Factors in Physically Inactive Overweight Adults: The BrainFit Study. Front Physiol. 2018 Jun 27;9:741. doi: 10.3389/fphys.2018.00741. eCollection 2018.
PubMed 29997519

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of High Intensity Interval- vs Resistance or Combined- Training for Improving Cognitive Function and Neurotrophic Factors in Overweight Adults (BrainFit Study): Factorial Randomised Controlled Trial
ClinicalTrials.gov ID: NCT02915913
Acronym / sponsor ID: BrainFit / 2016-09-22
Conditions: Cognitive Function, Motor Activity, Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Universidad Santo TomasUniversity, hospital or other
Collaborators: Universidad del Rosario, Universidad Nacional de Colombia
Study start: Sep 2016
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 27 Sep 2016 (estimated)
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

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (investigator)
Number of arms: 4

Arm	Type	Receives
High Intensity Interval	Experimental	Behavioral: Experimental: High Intensity IntervalOne session for 30-60 minutes of high intensity aerobic exercise
Resistance training	Experimental	Behavioral: Resistance trainingOne session for 30-60 minutes of resistance exercise
Plus: High Intensity Interval + Resistance Training	Experimental	Behavioral: Plus: High Intensity Interval + Resistance TrainingOne session for 30-60 minutes of high intensity aerobic exercise and resistance exercise
Non-exercise	Placebo comparator	Other: Non-exerciseNon-exercise

Who may qualify

Ages: 18 to 30 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Written informed consent.
Interested in improving health and fitness.
Central obesity: waist circumference ≥90cm
Body mass index ≥ 26 kg/m(2)

Key exclusion criteria (11 listed)

Systemic infections.
Weight loss or gain of >10% of body weight in the past 6 months for any reason.
Currently taking medication that suppresses or stimulates appetite.
Uncontrolled hypertension: systolic blood pressure 160 mm Hg or diastolic blood pressure 95 mm Hg on treatment.
Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).

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
Experimental: High Intensity IntervalWalking on a treadmill 4min at 80-90% peak heart rate and recovery 4 min at 65% peak heart rate until expenditure of 500 kcal	Behavioural	High Intensity Interval
Resistance trainingCompleting a resistance circuit (including upper and lower muscle groups) as many times as needed according to subject weight until expenditure of 500 kcal	Behavioural	Resistance training
Plus: High Intensity Interval + Resistance TrainingWalking on a treadmill as intervention 1 until 50% the energy expenditure prescribed is reached, then completing a resistance circuit until 100% energy expenditure is reached	Behavioural	Plus: High Intensity Interval + Resistance Training
Non-exerciseThis group will receive the usual clinical care according to the consensus recommendations of the national goals for cardiovascular health promotion and disease reduction of the American Heart Association and Colombian guidelines COLDEPORTES.	Other	Non-exercise

Primary outcome

Change from Baseline in Brain-derived neurotrophic factor
Time frame: Baseline and 60 minutes immediately after the interventions ends
Measurement of serum Brain-derived neurotropic factor true blood samples.

3 secondary outcomes

Change from Baseline in Neurotrophin-3
Time frame: Baseline and 60 minutes immediately after the interventions ends
Change from Baseline in Neurotrophin-4
Time frame: Baseline and 60 minutes immediately after the interventions ends
Change from Baseline change in Cognitive Function
Time frame: Baseline and 60 minutes immediately after the interventions ends

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 11 Oct 2018.
Derived from this study: PubMed 29997519Dominguez-Sanchez MA, Bustos-Cruz RH, Velasco-Orjuela GP, Quintero AP, Tordecilla-Sanders A, Correa-Bautista JE, Triana-Reina HR, Garcia-Hermoso A, Gonzalez-Ruiz K, Pena-Guzman CA, Hernandez E, Pena-Ibagon JC, Tellez-T LA, Izquierdo M, Ramirez-Velez R. Acute Effects of High Intensity, Resistance, or Combined Protocol on the Increase of Level of Neurotrophic Factors in Physically Inactive Overweight Adults: The BrainFit Study. Front Physiol. 2018 Jun 27;9:741. doi: 10.3389/fphys.2018.00741. eCollection 2018.
Individual participant dataSharing planned: No

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Not yet recruitingPhase 2
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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.

Robinson Ramírez-Vélez, Ph.D study director

Universidad del Rosario

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 11 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 11 Oct 2018. 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 Colombia. 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. Some participants in this study may receive a placebo. 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?

Change from Baseline in Brain-derived neurotrophic factor (time frame: Baseline and 60 minutes immediately after the interventions ends). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02915913, which also lists 1 linked publication.

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 11 Oct 2018.