The Influence of 5-HTTLPR and BDNF Polymorphisms on Anxiety and Mood After Acute Exercise

NCT03556176 | Completed DMC

• 1 other identifier: 2.331.601
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The Influence of 5-HTTLPR and BDNF Polymorphisms on Anxiety and Mood After Acute Exercise. Introduction: The 5-HTTLPR (SLC6A4) and BDNF (Val66Met) polymorphism presents an action on the modulation of human behavior and has received great attention as a risk factor for several psychiatric disorders. In recent years, a growing number of studies have evaluated the association between these polymorphisms and personality traits related to anxiety and depression. Objectives: To determine the frequencies of 5-HTTLPR and BDNF polymorphisms in a college students population; To determine the influence of 5-HTTLPR and BDNF polymorphisms on mood states and anxiety after acute physical exercise. Material and Methods: Four hundred (400) College students will be assessed. In the first phase of the study, the following procedures will be performed: Screening, Aerobic Fitness Assessment (Step Test), Questionnaires (PAR-Q, Habitual Physical Activity Level, Beck Anxiety and Depression Scale, State-Trait Anxiety, and Perceived Stress Scale), blood sample collection and genotyping. In the second phase of the study, two (2) groups with or without polymorphisms will be selected (for each gene). These groups will be submitted to four conditions (three experimental conditions and one control condition), carried out randomly and separated by an interval of 1 week. In the experimental Conditions the volunteers will perform treadmill exercises sessions (30 minutes) in three different intensities (light, moderate and vigorous) and will respond to the Borg Scale at 10, 20 e 30 minutes. In the control condition the volunteers will be instructed to remain seated (quiet rest), relaxed and silent for 30 minutes. In both conditions, the volunteers will complete the Profile of Mood States (POMS) and State-Anxiety (STAY), 05 (five) minutes before and, 5 (five) and 20 (twenty) minutes following the interventions.

Conditions

Polymorphisms; Exercise; Mood

Keywords

Anxiety; Mood; Physical activity; Polymorphisms

Outcome Measures

Primary Outcomes (2)

• Response of mood states after interventions

  The POMS questionnaire is an instrument to evaluate mood states. It has 65 items and 6 domains: tension-anxiety, depression, anger-hostility, vigour-activity, fatigue, and confusion- bewilderment. The total mood disturbance score is derived by subtracting the vigour-activity score from the the sum of scores from the other subscales. The iceberg profile is characterized by low raw scores on the tension, depression, anger, fatigue, and confusion scales and above norms (the "water line") on vigor.

  Change from 5 minutes before the treatments to 5 and 20 minutes after three exercise intensities and quiet rest

• Response of anxiety after interventions

  Anxiety Inventory-STAI trait-state. The scales encompasses 20 items and provides a one-dimensional measurement of anxiety. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms.

  Change from 5 minutes before the treatments to 5 and 20 minutes after three exercise intensities and quiet rest

Secondary Outcomes (6)

• Evaluation safety or possible risk of exercising

  baseline

• Habitual Physical Activity Level

  Baseline

• Evaluation of depression and anxiety symptoms

  Baseline

• Estimation the aerobic capacity

  Baseline

• Detection of the polymorphism in the SLC6A4

  Baseline

Study Arms (2)

5-HTTLPR or BDNF polymorphisms

ACTIVE COMPARATOR

Behavioral: Exercise; Behavioral: Quiet rest

Control ( without 5-HTTLPR or BDNF polymorphisms )

ACTIVE COMPARATOR

Behavioral: Exercise; Behavioral: Quiet rest

Interventions

Exercise BEHAVIORAL

Three exercises sessions - 30 min (light: 45 - 50%, moderate: 65 -70% and vigorous: 85 - 90% Heart Rate Maximal).

5-HTTLPR or BDNF polymorphisms; Control ( without 5-HTTLPR or BDNF polymorphisms )

Quiet rest BEHAVIORAL

Quiet rest during 30 min

5-HTTLPR or BDNF polymorphisms; Control ( without 5-HTTLPR or BDNF polymorphisms )

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age;
• able to perform physical activities;
• history of cardiovascular or respiratory diseases;
• smoking;
• use of psychiatric drugs;
• psychotherapy treatment in the last six months.

Sponsors & Collaborators

• Universidade Federal de Goias: lead

Study Sites (1)

UFG

Jatai, Goiás, 75800-000, Brazil

Location

MeSH Terms

Conditions

Motor Activity; Anxiety Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: June 14, 2018
• Study Start: July 30, 2018
• Primary Completion: October 1, 2019
• Study Completion: May 15, 2020
• Last Updated: May 18, 2020

Record last verified: 2020-05

Locations

BR (1)