NCT02915913

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

3 months

First QC Date

September 22, 2016

Last Update Submit

October 10, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Brain-derived neurotrophic factor

    Measurement of serum Brain-derived neurotropic factor true blood samples.

    Baseline and 60 minutes immediately after the interventions ends

Secondary Outcomes (3)

  • Change from Baseline in Neurotrophin-3

    Baseline and 60 minutes immediately after the interventions ends

  • Change from Baseline in Neurotrophin-4

    Baseline and 60 minutes immediately after the interventions ends

  • Change from Baseline change in Cognitive Function

    Baseline and 60 minutes immediately after the interventions ends

Study Arms (4)

High Intensity Interval

EXPERIMENTAL

One session for 30-60 minutes of high intensity aerobic exercise

Behavioral: Experimental: High Intensity Interval

Resistance training

EXPERIMENTAL

One session for 30-60 minutes of resistance exercise

Behavioral: Resistance training

Plus: High Intensity Interval + Resistance Training

EXPERIMENTAL

One session for 30-60 minutes of high intensity aerobic exercise and resistance exercise

Behavioral: Plus: High Intensity Interval + Resistance Training

Non-exercise

PLACEBO COMPARATOR

Non-exercise

Other: Non-exercise

Interventions

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

High Intensity Interval

Completing a resistance circuit (including upper and lower muscle groups) as many times as needed according to subject weight until expenditure of 500 kcal

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

Plus: High Intensity Interval + Resistance Training

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.

Non-exercise

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robinson Ramírez-Vélez

Bogota, Cundinamarca, 000000000, Colombia

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor ActivityObesity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Robinson Ramírez-Vélez, Ph.D

    Universidad del Rosario

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2016

First Posted

September 27, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 11, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations