Back to resultsEffects of Exercise Training on Cognitive Function and Neurotrophic Factors in Overweight Adults (BrainFit)
Primary Purpose
Cognitive Function, Motor Activity, Obesity
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Experimental: High Intensity Interval
Resistance training
Plus: High Intensity Interval + Resistance Training
Non-exercise
Sponsored by
About this trial
This is an interventional prevention trial for Cognitive Function
Eligibility Criteria
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).
Sites / Locations
- Robinson Ramírez-Vélez
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
High Intensity Interval
Resistance training
Plus: High Intensity Interval + Resistance Training
Non-exercise
Arm Description
One session for 30-60 minutes of high intensity aerobic exercise
One session for 30-60 minutes of resistance exercise
One session for 30-60 minutes of high intensity aerobic exercise and resistance exercise
Non-exercise
Outcomes
Primary Outcome Measures
Change from Baseline in Brain-derived neurotrophic factor
Measurement of serum Brain-derived neurotropic factor true blood samples.
Secondary Outcome Measures
Change from Baseline in Neurotrophin-3
Change from Baseline in Neurotrophin-4
Change from Baseline change in Cognitive Function
Cognitive Performance Test (BPT) computerized cognitive assessment battery developed by Lumos Labs, Inc.
Full Information
NCT ID
NCT02915913
First Posted
September 22, 2016
Last Updated
October 10, 2018
Sponsor
Universidad Santo Tomas
Collaborators
Universidad del Rosario, Universidad Nacional de Colombia
1. Study Identification
Unique Protocol Identification Number
NCT02915913
Brief Title
Effects of Exercise Training on Cognitive Function and Neurotrophic Factors in Overweight Adults
Acronym
BrainFit
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Santo Tomas
Collaborators
Universidad del Rosario, Universidad Nacional de Colombia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Function, Motor Activity, Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Intensity Interval
Arm Type
Experimental
Arm Description
One session for 30-60 minutes of high intensity aerobic exercise
Arm Title
Resistance training
Arm Type
Experimental
Arm Description
One session for 30-60 minutes of resistance exercise
Arm Title
Plus: High Intensity Interval + Resistance Training
Arm Type
Experimental
Arm Description
One session for 30-60 minutes of high intensity aerobic exercise and resistance exercise
Arm Title
Non-exercise
Arm Type
Placebo Comparator
Arm Description
Non-exercise
Intervention Type
Behavioral
Intervention Name(s)
Experimental: High Intensity Interval
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Resistance training
Intervention Description
Completing a resistance circuit (including upper and lower muscle groups) as many times as needed according to subject weight until expenditure of 500 kcal
Intervention Type
Behavioral
Intervention Name(s)
Plus: High Intensity Interval + Resistance Training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Non-exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Brain-derived neurotrophic factor
Description
Measurement of serum Brain-derived neurotropic factor true blood samples.
Time Frame
Baseline and 60 minutes immediately after the interventions ends
Secondary Outcome Measure Information:
Title
Change from Baseline in Neurotrophin-3
Time Frame
Baseline and 60 minutes immediately after the interventions ends
Title
Change from Baseline in Neurotrophin-4
Time Frame
Baseline and 60 minutes immediately after the interventions ends
Title
Change from Baseline change in Cognitive Function
Description
Cognitive Performance Test (BPT) computerized cognitive assessment battery developed by Lumos Labs, Inc.
Time Frame
Baseline and 60 minutes immediately after the interventions ends
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robinson Ramírez-Vélez, Ph.D
Organizational Affiliation
Universidad del Rosario
Official's Role
Study Director
Facility Information:
Facility Name
Robinson Ramírez-Vélez
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
000000000
Country
Colombia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29997519
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Exercise Training on Cognitive Function and Neurotrophic Factors in Overweight Adults
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