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

October 10, 2018 updated by: Universidad Santo Tomas

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 000000000
        • Robinson Ramírez-Vélez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Intensity Interval
One session for 30-60 minutes of high intensity aerobic exercise
Behavioral: Experimental: High Intensity Interval
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
Experimental: Resistance training
One session for 30-60 minutes of resistance exercise
Behavioral: Resistance training
Completing a resistance circuit (including upper and lower muscle groups) as many times as needed according to subject weight until expenditure of 500 kcal
Experimental: Plus: High Intensity Interval + Resistance Training
One session for 30-60 minutes of high intensity aerobic exercise and resistance exercise
Behavioral: Plus: High Intensity Interval + Resistance Training
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
Placebo Comparator: Non-exercise
Other: Non-exercise
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 60 minutes immediately after the interventions ends

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Neurotrophin-3
Time Frame: Baseline and 60 minutes immediately after the interventions ends
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
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
Cognitive Performance Test (BPT) computerized cognitive assessment battery developed by Lumos Labs, Inc.
Baseline and 60 minutes immediately after the interventions ends

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Santo Tomas

Collaborators

Universidad Nacional de Colombia
Universidad del Rosario

Investigators

  • Study Director: Robinson Ramírez-Vélez, Ph.D, Universidad del Rosario

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 22, 2016

First Submitted That Met QC Criteria

September 23, 2016

First Posted (Estimate)

September 27, 2016

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-09-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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