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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02915913
Date of registration: 22/09/2016
Prospective Registration: No
Primary sponsor: Universidad Santo Tomas
Public title: Effects of Exercise Training on Cognitive Function and Neurotrophic Factors in Overweight Adults BrainFit
Scientific 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
Date of first enrolment: September 2016
Target sample size: 60
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02915913
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Prevention. Masking: Single (Investigator).  
Phase:  N/A
Countries of recruitment
Colombia
Contacts
Name:     Robinson Ramírez-Vélez, Ph.D
Address: 
Telephone:
Email:
Affiliation:  Universidad del Rosario
Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: 30 Years
Gender: Male
Health Condition(s) or Problem(s) studied
Motor Activity
Cognitive Function
Obesity
Intervention(s)
Behavioral: Resistance training
Other: Non-exercise
Behavioral: Experimental: High Intensity Interval
Behavioral: Plus: High Intensity Interval + Resistance Training
Primary Outcome(s)
Change from Baseline in Brain-derived neurotrophic factor [Time Frame: Baseline and 60 minutes immediately after the interventions ends]
Secondary Outcome(s)
Change from Baseline change in Cognitive Function [Time Frame: Baseline and 60 minutes immediately after the interventions ends]
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]
Secondary ID(s)
2016-09-22
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Universidad Nacional de Colombia
Universidad del Rosario
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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