Cognitive Function and Well-BeingAPICANCT03441386
Acute Physical Exercise Intensity on Adolescents Cognitive Function
A study testing Physical Exercise Session in people with Cognitive Function and Well-Being, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial summary
Cognitive function and psychological well-being are two variables related to academic performance. Several studies have shown that these variables are sensitive to acute physical exercise, but it is not known which doses of exercise are the most adaptive. Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function and Well-Being
- What is being tested?
- Physical Exercise Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2015to 15 Apr 2017
- 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 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents participants in official Physical Education studies
Who cannot join
- They must be authorized by their parents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Physical Exercise Intensity on Cognitive Inhibition and Psychological Well-being in Adolescents
Cognitive function and psychological well-being are two variables related to academic performance. Several studies have shown that these variables are sensitive to acute physical exercise, but it is not known which doses of exercise are the most adaptive. To explore this issue, a quasi-experimental study was conducted with 35 adolescents from three physical education classes. Participants performed three sessions of physical education with different doses of exercise: no exercise, light/moderate exercise, and moderate/vigorous exercise, controlling intensities with accelerometers. All subjects completed the Stroop test (to measure cognitive inhibition) and well-being questionnaires of subjective vitality, positive affect and negative affect before and after each session.
Read the detailed description
Participants The initial sample comprised 35 students from 2nd grade of high school (19 boys and 16 girls), aged between 16 and 18 years (M =16.49, SD = .79). The students belonged to a public school of a large city in Spain.
Ethical approval and informed consent The experiment was approved by the Ethics Committee of the authors' university and approved by the corresponding academic authority of the high school. All participants signed an informed consent by themselves and their parents.
Measures Measure of Interference Index (Stroop Test). The interference index was calculated from the scores obtained by the participants in the Spanish adaptation of the Stroop test 25 using a pencil-and-paper version.
The test consists of three pages of words and drawings printed in colors that combine in different ways. The first set or page, called Word (W), is made up of the words blue, green, and red, written in black ink on a white background. The second page, called Color (C), presents groups of four Xs (XXXX), printed in one of the above-mentioned colors (blue, red or green). The participants are requested to name the color of the four Xs presented. The last page, called Word-Color (WC) is made up of the names of the colors that appear on page 1, but in ink colors that are incongruent with the printed word. Participants are requested to name the color while inhibiting the reading of the word.
All the pages have 100 items, and each test lasts 45 seconds. The number of hits is added. For this study, we calculated the interference index with the formula, Interference Index = WC - ((WxC)/(W+C)). As indicated by Martín et al. (2012), this index represents the difference between the real performance on page 3 and the expected performance as a function of the hits on pages 1 and 2. Higher values indicate better control of interference.
Measure of psychological well-being Subjective vitality. To measure the students' perception of vitality before and after the three sessions, we used the Subjective Vitality Questionnaire 26, adapted to Spanish by Molina-García, Castillo, and Pablos 27. This questionnaire can be considered as a eudaimonic measure of psychological well-being 17. The questionnaire is made up of 7 items that indicate how the person feels at that moment (e.g., "I am full of energy"). The responses are rated on an 8-point Likert-type scale ranging from 0 (not at all) to 7 (very true). Cronbach's alpha in the different experimental situations ranged from .74 to .82.
Affect. The Spanish version 19 of the short form of the Positive and Negative Affect Schedule 28 was used to measure positive and negative feelings before and after the sessions of physical education. This questionnaire is considered a hedonic measure of well-being. The scale is made up of 9 adjectives, which are grouped into two factors in response to the item "Indicate how you feel right now…". Four of the items represent feelings associated with Positive Affect (glad, happy, content, amused), and five of them represent Negative Affect (depressed, worried, frustrated, angry, unhappy). The responses are rated on an 8-point Likert-type scale ranging from 1 (not at all) to 7 (extremely). Cronbach´s alpha ranged between .76 and. 90 for the two factors in the present study.
Procedure Only the participants who handed in an informed consent signed by themselves, their parents, and the school could participate. They were informed of the confidentiality and anonymity of the results obtained. Although all the adolescents of the three classes that participated in the study underwent all the experimental sessions (as a part of their physical education curriculum), the investigators only measured the students who had handed in the signed informed consent. The final sample (N = 35) was made up of those who participated in all the pre and post-experimental sessions. The investigators counterbalanced the three experimental sessions in the three classes. The participants carried out four sessions (one pre-experimental session and three experimental sessions).
Pre-experimental session. In the first session, the participants completed the socio-demographic data and then carried out a Stroop test training session, before receiving a theoretical physical education class, in order to prevent a possible "learning effect" in test performance. The participants performed a minimum of 2 attempts of each page. When the participants made two attempts with a variability of intra-page hits below 5% with regard to the previous attempt, the training session ended. Thus, the researchers respected individual variability in learning the test. Prior studies have also used this percentage of intra-variability as an indication of stable performance in cognitive inhibition tests 24. Nevertheless, recent studies have shown that the intra-class correlation coefficient of the test in the paper-and-pencil version in Spanish is high when comparing different temporal measures in the same population.
Experimental sessions. The other three sessions consisted of: (a) a 20-min theoretical physical education session, without a physical component, in which the students answered questions about theoretical concepts of training; (b) a session of physical activity of light and moderate intensity, structured as follows: a 5-min warm-up, 20 min of predominantly light and moderate physical activity, and a 5-min cool-off; and (c) a session of physical activity of predominantly moderate and vigorous intensity, with the same structure as before. There was a one-week interval between the sessions. The physical activity sessions were based on aerobics class directed by an instructor.
The duration of the main part of the sessions was established from previous recommendations, which indicate that, for acute sessions of physical activity, the greatest cognitive benefits are obtained with durations of about 20 minutes.
Before and after each session, the adolescents completed the instruments that measured psychological well-being and cognitive interference. The data were collected 15 minutes after the end of each session.
Control of the intensity of the exercise. To control the intensity of the sessions, in addition to measures with accelerometry in each session, the investigators performed a pilot study with 5 adolescents in which they adjusted the intensity of the exercises and the recovery times to ensure that they fulfilled the goals of the session. For this purpose, the investigators used simple aerobic exercises that do not pose any coordination difficulties, and the students followed a monitor's instructions. After adapting the sessions, they were performed in the experimental situation.
The investigators calculated the intensity of the sessions with accelerometry. The investigators used tri-axial GT3X accelerometers that each of the participants wore while performing sessions "b" and "c". The students were shown how to put on and use the accelerometer before beginning the sessions 30. The frequency of time storage was a 1-second "epoch". The investigators ignored periods of use fewer than 15 epochs, and periods of no activity of longer than 1 minute were eliminated from the analysis. The software used for data treatment was ActiLife 6 (Actigraph, Actilife version 6.11.5) and to define the type of activity (light/moderate and moderate/vigorous), the investigators used the cutpoints defined by 31. The investigators chose this author because he clearly and concisely defines the cutpoints as a function of concrete ages. The specific criteria for each age are found in the SAS code available at http://epi.grants.cancer.gov/nhanes_pam/ (National Cancer Institute).
- Conditions
- Cognitive Function and Well-Being
- Being tested
- Physical Exercise Session
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Exercise SessionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Study | Experimental | Cognitive Responses was analyzed after different intensities physical exercise sessions. Receives: Behavioral: Physical Exercise Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Inhibition Interference Index
A pen and papel Stroop Test meassure
Measured: 5 minutes after exercise session
Subjective Vitality
Perception of Vitality by Subjective Vitality Questionaire, The questionnaire is made up of 7 items that indicate how the person feels at that moment (e.g., "I am full of energy"). The responses are rated on an 8-point Likert-type scale ranging from 0 (not at all) to 7 (very true).
Measured: 5 minutes after exercise session
Affect
Positive and Negative Affect Schedule, Four of the items represent feelings associated with Positive Affect (glad, happy, content, amused), and five of them represent Negative Affect (depressed, worried, frustrated, angry, unhappy). The responses are rated on an 8-point Likert-type scale ranging from 1 (not at all) to 7 (extremely).
Measured: 5 minutes after exercise session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start15 Jan 2015
- Primary completion15 Mar 2015
- Study completion15 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Function and Well-BeingStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Three counterbalanced experimental sessions for the same group
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Pastor, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441386
- Sponsor's protocol ID
- DPS.EC.02.16
- Acronym
- APICA
- Status last verified
- Feb 2018
- First submitted
- 15 Feb 2018
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Physical Exercise Intensity on Cognitive Inhibition and Psychological Well-being in Adolescents
- ClinicalTrials.gov ID
- NCT03441386
- Acronym / sponsor ID
- APICA / DPS.EC.02.16
- Conditions
- Cognitive Function and Well-Being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- 15 Jan 2015 (actual)
- Primary completion
- 15 Mar 2015 (actual)
- Study completion
- 15 Apr 2017 (actual)
- First posted
- 22 Feb 2018 (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.
Cognitive function and psychological well-being are two variables related to academic performance. Several studies have shown that these variables are sensitive to acute physical exercise, but it is not known which doses of exercise are the most adaptive. To explore this issue, a quasi-experimental study was conducted with 35 adolescents from three physical education classes. Participants performed three sessions of physical education with different doses of exercise: no exercise, light/moderate exercise, and moderate/vigorous exercise, controlling intensities with accelerometers. All subjects completed the Stroop test (to measure cognitive inhibition) and well-being questionnaires of subjective vitality, positive affect and negative affect before and after each session.
Detailed description
Participants The initial sample comprised 35 students from 2nd grade of high school (19 boys and 16 girls), aged between 16 and 18 years (M =16.49, SD = .79). The students belonged to a public school of a large city in Spain.
Ethical approval and informed consent The experiment was approved by the Ethics Committee of the authors' university and approved by the corresponding academic authority of the high school. All participants signed an informed consent by themselves and their parents.
Measures Measure of Interference Index (Stroop Test). The interference index was calculated from the scores obtained by the participants in the Spanish adaptation of the Stroop test 25 using a pencil-and-paper version.
The test consists of three pages of words and drawings printed in colors that combine in different ways. The first set or page, called Word (W), is made up of the words blue, green, and red, written in black ink on a white background. The second page, called Color (C), presents groups of four Xs (XXXX), printed in one of the above-mentioned colors (blue, red or green). The participants are requested to name the color of the four Xs presented. The last page, called Word-Color (WC) is made up of the names of the colors that appear on page 1, but in ink colors that are incongruent with the printed word. Participants are requested to name the color while inhibiting the reading of the word.
All the pages have 100 items, and each test lasts 45 seconds. The number of hits is added. For this study, we calculated the interference index with the formula, Interference Index = WC - ((WxC)/(W+C)). As indicated by Martín et al. (2012), this index represents the difference between the real performance on page 3 and the expected performance as a function of the hits on pages 1 and 2. Higher values indicate better control of interference.
Measure of psychological well-being Subjective vitality. To measure the students' perception of vitality before and after the three sessions, we used the Subjective Vitality Questionnaire 26, adapted to Spanish by Molina-García, Castillo, and Pablos 27. This questionnaire can be considered as a eudaimonic measure of psychological well-being 17. The questionnaire is made up of 7 items that indicate how the person feels at that moment (e.g., "I am full of energy"). The responses are rated on an 8-point Likert-type scale ranging from 0 (not at all) to 7 (very true). Cronbach's alpha in the different experimental situations ranged from .74 to .82.
Affect. The Spanish version 19 of the short form of the Positive and Negative Affect Schedule 28 was used to measure positive and negative feelings before and after the sessions of physical education. This questionnaire is considered a hedonic measure of well-being. The scale is made up of 9 adjectives, which are grouped into two factors in response to the item "Indicate how you feel right now…". Four of the items represent feelings associated with Positive Affect (glad, happy, content, amused), and five of them represent Negative Affect (depressed, worried, frustrated, angry, unhappy). The responses are rated on an 8-point Likert-type scale ranging from 1 (not at all) to 7 (extremely). Cronbach´s alpha ranged between .76 and. 90 for the two factors in the present study.
Procedure Only the participants who handed in an informed consent signed by themselves, their parents, and the school could participate. They were informed of the confidentiality and anonymity of the results obtained. Although all the adolescents of the three classes that participated in the study underwent all the experimental sessions (as a part of their physical education curriculum), the investigators only measured the students who had handed in the signed informed consent. The final sample (N = 35) was made up of those who participated in all the pre and post-experimental sessions. The investigators counterbalanced the three experimental sessions in the three classes. The participants carried out four sessions (one pre-experimental session and three experimental sessions).
Pre-experimental session. In the first session, the participants completed the socio-demographic data and then carried out a Stroop test training session, before receiving a theoretical physical education class, in order to prevent a possible "learning effect" in test performance. The participants performed a minimum of 2 attempts of each page. When the participants made two attempts with a variability of intra-page hits below 5% with regard to the previous attempt, the training session ended. Thus, the researchers respected individual variability in learning the test. Prior studies have also used this percentage of intra-variability as an indication of stable performance in cognitive inhibition tests 24. Nevertheless, recent studies have shown that the intra-class correlation coefficient of the test in the paper-and-pencil version in Spanish is high when comparing different temporal measures in the same population.
Experimental sessions. The other three sessions consisted of: (a) a 20-min theoretical physical education session, without a physical component, in which the students answered questions about theoretical concepts of training; (b) a session of physical activity of light and moderate intensity, structured as follows: a 5-min warm-up, 20 min of predominantly light and moderate physical activity, and a 5-min cool-off; and (c) a session of physical activity of predominantly moderate and vigorous intensity, with the same structure as before. There was a one-week interval between the sessions. The physical activity sessions were based on aerobics class directed by an instructor.
The duration of the main part of the sessions was established from previous recommendations, which indicate that, for acute sessions of physical activity, the greatest cognitive benefits are obtained with durations of about 20 minutes.
Before and after each session, the adolescents completed the instruments that measured psychological well-being and cognitive interference. The data were collected 15 minutes after the end of each session.
Control of the intensity of the exercise. To control the intensity of the sessions, in addition to measures with accelerometry in each session, the investigators performed a pilot study with 5 adolescents in which they adjusted the intensity of the exercises and the recovery times to ensure that they fulfilled the goals of the session. For this purpose, the investigators used simple aerobic exercises that do not pose any coordination difficulties, and the students followed a monitor's instructions. After adapting the sessions, they were performed in the experimental situation.
The investigators calculated the intensity of the sessions with accelerometry. The investigators used tri-axial GT3X accelerometers that each of the participants wore while performing sessions "b" and "c". The students were shown how to put on and use the accelerometer before beginning the sessions 30. The frequency of time storage was a 1-second "epoch". The investigators ignored periods of use fewer than 15 epochs, and periods of no activity of longer than 1 minute were eliminated from the analysis. The software used for data treatment was ActiLife 6 (Actigraph, Actilife version 6.11.5) and to define the type of activity (light/moderate and moderate/vigorous), the investigators used the cutpoints defined by 31. The investigators chose this author because he clearly and concisely defines the cutpoints as a function of concrete ages. The specific criteria for each age are found in the SAS code available at http://epi.grants.cancer.gov/nhanes_pam/ (National Cancer Institute).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
- Model description
- Three counterbalanced experimental sessions for the same group
| Arm | Type | Receives |
|---|---|---|
| Cognitive Study | Experimental | Behavioral: Physical Exercise SessionCognitive Responses was analyzed after different intensities physical exercise sessions. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescents participants in official Physical Education studies
Key exclusion criteria (1 listed)
- They must be authorized by their parents.
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 |
|---|---|---|
| Physical Exercise Session | Behavioural | Cognitive Study |
Primary outcome
Cognitive Inhibition Interference Index
Time frame: 5 minutes after exercise session
A pen and papel Stroop Test meassure
Subjective Vitality
Time frame: 5 minutes after exercise session
Perception of Vitality by Subjective Vitality Questionaire, The questionnaire is made up of 7 items that indicate how the person feels at that moment (e.g., "I am full of energy"). The responses are rated on an 8-point Likert-type scale ranging from 0 (not at all) to 7 (very true).
Affect
Time frame: 5 minutes after exercise session
Positive and Negative Affect Schedule, Four of the items represent feelings associated with Positive Affect (glad, happy, content, amused), and five of them represent Negative Affect (depressed, worried, frustrated, angry, unhappy). The responses are rated on an 8-point Likert-type scale ranging from 1 (not at all) to 7 (extremely).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercise Session in people with Cognitive Function and Well-Being, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
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 1 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: finished, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Inhibition Interference Index (time frame: 5 minutes after exercise session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2018.