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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Spain1 site
  • Universidad Miguel Hernández de Elche

    Elche, Alicante, 03202

Other trials in Spain

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).

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 groups in NCT03441386
Study groupRoleWhat they receive
Cognitive StudyExperimentalCognitive 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.

  1. Cognitive Inhibition Interference Index

    A pen and papel Stroop Test meassure

    Measured: 5 minutes after exercise session

  2. 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

  3. 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.

  1. First posted22 Feb 2018
  2. Study start15 Jan 2015
  3. Primary completion15 Mar 2015
  4. Study completion15 Apr 2017

Resources

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)
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

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.

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