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

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ClinicalTrials.gov Identifier: NCT02915913
Recruitment Status : Completed
First Posted : September 27, 2016
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
Universidad del Rosario
Universidad Nacional de Colombia
Information provided by (Responsible Party):
Universidad Santo Tomas

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.

Condition or disease Intervention/treatment Phase
Cognitive Function Motor Activity Obesity Behavioral: Experimental: High Intensity Interval Behavioral: Resistance training Behavioral: Plus: High Intensity Interval + Resistance Training Other: Non-exercise Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
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 Start Date : September 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change from Baseline in Neurotrophin-3 [ Time Frame: Baseline and 60 minutes immediately after the interventions ends ]
  2. Change from Baseline in Neurotrophin-4 [ Time Frame: Baseline and 60 minutes immediately after the interventions ends ]
  3. 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.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915913


Locations
Colombia
Robinson Ramírez-Vélez
Bogota, Cundinamarca, Colombia, 000000000
Sponsors and Collaborators
Universidad Santo Tomas
Universidad del Rosario
Universidad Nacional de Colombia
Investigators
Study Director: Robinson Ramírez-Vélez, Ph.D Universidad del Rosario

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Universidad Santo Tomas
ClinicalTrials.gov Identifier: NCT02915913     History of Changes
Other Study ID Numbers: 2016-09-22
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms