- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05508685
Effects of Hiit Associated With Emotional Regulation on Negative Emotions
Study Overview
Status
Detailed Description
Main goal
To evaluate the effects of high-intensity interval training (HIIT) associated with a cognitive reassessment strategy on negative emotions in sedentary women.
Specific objectives
Evaluate and compare the positive and negative affective of women in three moments; Evaluate and compare the intensity and valence of emotions in three moments; Investigate possible associations between emotion dysregulation and emotion regulation strategies in positive and negative affect; Investigate and compare HIIT intensity and emotion regulation strategy in pleasure and displeasure during physical exercise during practice.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Irinaldo Capitulino
- Phone Number: 8399932-4351
- Email: irinaldocsouzza@gmail.com
Study Contact Backup
- Name: Melyssa Kellyane Cavalcanti Galdino, Dra
- Phone Number: 8398767-3151
- Email: melyssa_cavalcanti@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
• No psychiatric or neurological disorder
Exclusion criteria:
- Using mood-altering medications
- Joint problems
- Practicing physical activity for six months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HIIT and Cognitive Reassessment
The experimental group will receive high-intensity interval training associated with cognitive reassessment
|
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.
|
|
Active Comparator: HIIT Group
The HITT group will receive only the exercise without cognitive reassessment
|
Participants will receive high-intensity interval training, lasting 40 minutes, focusing on upper and lower limbs.
|
|
Active Comparator: Emotional regulation strategy group
This group will receive only cognitive reassessment strategy
|
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.
|
|
Placebo Comparator: Group No exercise and cognitive reassessment
This group will only be evaluated in pre and post, without intervention.
|
Participants in this group will not receive any intervention.
Only pre and post experiment will be evaluated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positive and Negative Affect Scale
Time Frame: Fifteen days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self Assessment Manikin
Time Frame: Fifteen days
|
The Self-Assessment Mannequin (SAM) is a non-verbal pictorial assessment technique that directly measures pleasure, arousal, and mastery associated with a person's affective reaction to a wide variety of stimuli.
The reports are subjective to measure a series of images that varied in both valence and affective intensity.
|
Fifteen days
|
|
Feeling Scale
Time Frame: Fifteen days
|
The feeling scale was used to assess affective valence.
The 11-point bipolar scale ranging from very bad (-5) to very good (+5), with anchors at Neutral (0) and all odd integers, including bad (-3), fairly bad (-1), reasonably good (+1) and good (+3).
|
Fifteen days
|
|
The Perceived Effort Scale
Time Frame: Fifteen days
|
Borg's Perceived Exertion Rating (RPE) is a way of measuring the intensity level of physical activity.
These include a rating of 6 perceiving "no exertion" to 20 perceiving a "maximum exertion" of exertion.
Practitioners generally agree that perceived exertion ratings between 12 and 14 on the Borg Scale suggest that physical activity is being performed at a moderate level of intensity.
|
Fifteen days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ICdesouza
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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