High Intensity ExerciseNCT05508685
Effects of Hiit Associated With Emotional Regulation on Negative Emotions
A study testing HIIT and Cognitive Reassessment, HIIT group and Emotional regulation strategy group in people with High Intensity Exercise and Cognitive Reassessment Strategy, run by Federal University of Paraíba.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- High Intensity Exercise, Cognitive Reassessment Strategy
- What is being tested?
- HIIT and Cognitive Reassessment, HIIT group and Emotional regulation strategy group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2022to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- No psychiatric or neurological disorder
Who cannot join
- Using mood-altering medications
- Joint problems
- Practicing physical activity for six months
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Being tested
- HIIT and Cognitive Reassessment, HIIT group, Emotional regulation strategy group, placebo group
- Keywords
- High-Intensity Interval Training, Emotional Regulation, Affect
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT and Cognitive ReassessmentOther
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 groupOther
Participants will receive high-intensity interval training, lasting 40 minutes, focusing on upper and lower limbs.
Emotional regulation strategy groupOther
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 groupOther
Participants in this group will not receive any intervention. Only pre and post experiment will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| HIIT and Cognitive Reassessment | Experimental | The experimental group will receive high-intensity interval training associated with cognitive reassessment Receives: Other: HIIT and Cognitive Reassessment |
| HIIT Group | Active comparator | The HITT group will receive only the exercise without cognitive reassessment Receives: Other: HIIT group |
| Emotional regulation strategy group | Active comparator | This group will receive only cognitive reassessment strategy Receives: 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. Receives: Other: placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Fifteen days
Secondary outcomes (3)
Self Assessment Manikin
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.
Measured: Fifteen days
Feeling Scale
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).
Measured: Fifteen days
The Perceived Effort Scale
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.
Measured: Fifteen days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start30 Sep 2022 (estimated)
- Primary completion31 Oct 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for High Intensity ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irinaldo Capitulino de Souza, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508685
- Sponsor's protocol ID
- ICdesouza
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30064053Edwards 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.
PubMed 29309746Evans, 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 at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hiit Associated With Emotional Regulation on Negative Emotions
- ClinicalTrials.gov ID
- NCT05508685
- Acronym / sponsor ID
- ICdesouza
- Keywords
- High-Intensity Interval Training, Emotional Regulation, Affect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- 30 Sep 2022 (estimated)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIIT and Cognitive Reassessment | Experimental | Other: HIIT and Cognitive ReassessmentThe experimental group will receive high-intensity interval training associated with cognitive reassessment |
| HIIT Group | Active comparator | Other: HIIT groupThe HITT group will receive only the exercise without cognitive reassessment |
| Emotional regulation strategy group | Active comparator | Other: Emotional regulation strategy groupThis group will receive only cognitive reassessment strategy |
| Group No exercise and cognitive reassessment | Placebo comparator | Other: placebo groupThis group will only be evaluated in pre and post, without intervention. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- No psychiatric or neurological disorder
Key exclusion criteria (3 listed)
- Using mood-altering medications
- Joint problems
- Practicing physical activity for six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIIT and Cognitive ReassessmentParticipants 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. | Other | HIIT and Cognitive Reassessment |
| HIIT groupParticipants will receive high-intensity interval training, lasting 40 minutes, focusing on upper and lower limbs. | Other | HIIT Group |
| Emotional regulation strategy groupParticipants 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. | Other | Emotional regulation strategy group |
| placebo groupParticipants in this group will not receive any intervention. Only pre and post experiment will be evaluated. | Other | Group No exercise and cognitive reassessment |
Primary outcome
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.
3 secondary outcomes
Self Assessment Manikin
Time frame: Fifteen days
Feeling Scale
Time frame: Fifteen days
The Perceived Effort Scale
Time frame: Fifteen days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Background: PubMed 30064053Dryman 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.
- Background: PubMed 29309746Edwards 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.
- BackgroundEvans, 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.
- Individual participant dataSharing planned: No
Related trials for High Intensity Exercise
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study
Pediatric Brain Tumor
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Not yet recruiting
Acute Effects of High-Intensity Laser Therapy on Pain, Muscle Stiffness, and Grip Strength in Healthy Adults
Exercise-Induced Muscle Fatigue, Fatigue Recovery
Active, not recruiting
Flexibility, Resistance, Aerobic, Movement Execution Training in Adults With Hereditary Spastic Paraplegia
Hereditary Spastic Paraplegia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT and Cognitive Reassessment, HIIT group and Emotional regulation strategy group in people with High Intensity Exercise and Cognitive Reassessment Strategy, run by Federal University of Paraíba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irinaldo Capitulino (8399932-4351, irinaldocsouzza@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Affect Scale (time frame: Fifteen days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05508685, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.