NCT05508685

Brief Summary

Despite the benefits of physical exercise, the population does not adhere to the recommended levels of physical activity. The reported difficulties in starting and maintaining a physical exercise program are attributed to personal barriers and lack of motivation. Thus, there is an urgent need for efficient intervention proposals to increase engagement in daily physical exercise. High-intensity interval training (HIIT) is a promising and economical method, aiming at the development of efforts at high, maximum or supramaximal intensity, based on several methods: calisthenics (using the body's own strength) resistance (heavy objects, bars or devices for high-repetition resistance activities) and traditional (exercise modalities such as running and cycling). Emotional regulation (ER) is essential for the psychosocial well-being of human beings and is defined as the ability to influence, experience and express emotions, being an action, conscious or not, that directly modulates emotions and alters their nature as the intensity and duration. Regular physical exercise has been attributed to a reduction in depression symptoms, an increase in emotional well-being and a reduction in negative feelings. In addition to physical exercise, the use of cognitive reassessment to regulate emotions was positively associated with a decrease in negative affect in psychopathological diagnoses.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

August 16, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

1 month

First QC Date

August 16, 2022

Last Update Submit

August 20, 2022

Conditions

Keywords

High-Intensity Interval TrainingEmotional RegulationAffect

Outcome Measures

Primary Outcomes (1)

  • Positive and Negative Affect Scale

    Each item is rated on a five-point Likert scale, ranging from 1 = Very Slightly or Not at all to 5 = Extremely, to measure the extent to which affect was experienced in a specified period of time.

    Fifteen days

Secondary Outcomes (3)

  • Self Assessment Manikin

    Fifteen days

  • Feeling Scale

    Fifteen days

  • The Perceived Effort Scale

    Fifteen days

Study Arms (4)

HIIT and Cognitive Reassessment

EXPERIMENTAL

The experimental group will receive high-intensity interval training associated with cognitive reassessment

Other: HIIT and Cognitive Reassessment

HIIT Group

ACTIVE COMPARATOR

The HITT group will receive only the exercise without cognitive reassessment

Other: HIIT group

Emotional regulation strategy group

ACTIVE COMPARATOR

This group will receive only cognitive reassessment strategy

Other: Emotional regulation strategy group

Group No exercise and cognitive reassessment

PLACEBO COMPARATOR

This group will only be evaluated in pre and post, without intervention.

Other: placebo group

Interventions

Participants will receive 40 minutes of high-intensity interval training focusing on the upper and lower limbs associated with a cognitive reassessment strategy during the exercises.

HIIT and Cognitive Reassessment

Participants will receive high-intensity interval training, lasting 40 minutes, focusing on upper and lower limbs.

HIIT Group

Participants will be instructed to cognitively reassess the negative emotions they feel or do not feel during the practice of the exercises. Participants will receive instructions on how to reassess.

Emotional regulation strategy group

Participants in this group will not receive any intervention. Only pre and post experiment will be evaluated.

Group No exercise and cognitive reassessment

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No psychiatric or neurological disorder

You may not qualify if:

  • Using mood-altering medications
  • Joint problems
  • Practicing physical activity for six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Dryman MT, Heimberg RG. Emotion regulation in social anxiety and depression: a systematic review of expressive suppression and cognitive reappraisal. Clin Psychol Rev. 2018 Nov;65:17-42. doi: 10.1016/j.cpr.2018.07.004. Epub 2018 Jul 23.

    PMID: 30064053BACKGROUND
  • Edwards MK, Rhodes RE, Mann JR, Loprinzi PD. Effects of acute aerobic exercise or meditation on emotional regulation. Physiol Behav. 2018 Mar 15;186:16-24. doi: 10.1016/j.physbeh.2017.12.037. Epub 2018 Jan 5.

    PMID: 29309746BACKGROUND
  • Evans, M., Rohan, K. J., Howard, A., Ho, S. Y., Dubbert, P. M., & Stetson, B. A. (2017). Exercise dimensions and psychological well-being: A community-based exercise study. Journal of Clinical Sport Psychology, 11(2), 107-125.

    BACKGROUND

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Central Study Contacts

Irinaldo Capitulino

CONTACT

Melyssa Kellyane Cavalcanti Galdino, Dra

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 19, 2022

Study Start

September 30, 2022

Primary Completion

October 31, 2022

Study Completion

November 30, 2022

Last Updated

August 24, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share