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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06168526
Other study ID # UJI-B2022-37
Secondary ID CIGE/2021/053
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date September 2025

Study information

Verified date May 2024
Source Universitat Jaume I
Contact Maria Reyes Beltran Valls, PhD
Phone 964 729745
Email vallsm@uji.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Previous studies in young adults have shown that physical activity can generate positive emotions and improve attention, among other cognitive functions. This highlights the importance of evaluating how physical activity can affect cognition and affective dimensions. However, to date, the dose of physical activity that could be most effective for these variables has not been established. This project aims to study the impact of acute physical activity on brain health in a university setting. Thus, this study will contribute to expand the current scientific literature on the acute effect of physical activity, a topic of great importance both in the educational field and from a public health point of view.


Description:

Students in the university stage face many changes in their lives. These changes, partly derived from academic activity, can cause alterations in their lifestyle and brain health (i.e., cognitive, emotional, and behavioural functioning). Due to the negative association of several indicators of brain health with academic performance during the university stage, it is of interest to promote strategies that can favour it. Among them, previous studies in young adults have shown that physical activity can generate positive emotions and improve attention, among other cognitive functions. However, to date, the dose of physical activity (i.e., type, duration, and intensity) that could be most effective for these variables has not been established. Furthermore, previous studies in the matter have been carried out in laboratories and few investigations have analysed outside them the impact of acute physical activity on brain health in university classrooms. Therefore, expanding the current scientific literature on the acute effect of physical activity is of great importance in the educational field, since it would contribute to the design of active proposals aimed at improving brain health with positive implications for students' academic performance and quality of life. Accordingly, this project aims to carry out an acute physical activity intervention with different intensities and active breaks with students from the Jaume I University (Castellon de la Plana, Spain). More precisely, a total of 210 students between 18 and 24 years old will participate in the intervention. To achieve it, a randomized crossover study design will be carried out with the groups of participants compensated in terms of number and sex. Attention will be assessed using the d2-R questionnaire and emotional well-being will be assessed using the Positive and Negative Affect Schedule questionnaire. The tests evaluating attention and emotional well-being will be carried out before and after each condition. The experimental conditions will be: control group (quietly sitting), light intensity (40% VO2max), moderate intensity (63% VO2max), or vigorous intensity (100% VO2max) exercise, all lasting 16 minutes. In addition, an active break will be performed at the intensity of physical activity that proves to have the greatest benefits on cognition and well-being. Taking into account that the lifestyle of students is mainly characterized by the accumulation of prolonged periods of sedentary activity, introducing physical activity in the classroom represents an interesting opportunity for intervention from both an educational and a public health point of view.


Recruitment information / eligibility

Status Recruiting
Enrollment 210
Est. completion date September 2025
Est. primary completion date June 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 24 Years
Eligibility Inclusion Criteria: - Not to be diagnosed with psychological and/or cognitive alterations or pathologies that may limit the understanding and following of the instructions provided by another person. - Not to suffer physical alterations that may limit the practice of physical activity. - To be between 18 and 24 years old. Exclusion Criteria: - To be diagnosed with psychological and/or cognitive alterations or pathologies that may limit the understanding and following of the instructions provided by another person. - To suffer physical alterations that may limit the practice of physical activity. - Not to be between 18 and 24 years old.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Acute physical activity
Regarding the first aim, participants will go through five different conditions using a within-participants cross-over design in a randomized order: control group (quietly sitting), light intensity (40% VO2max), moderate intensity (63% VO2max), or vigorous intensity (100% VO2max) exercise. All conditions will last 16 minutes and 15 seconds. The exercise conditions will be organized following an interval protocol, which includes 22 bouts of 30 seconds running at the established intensity with 15 seconds of passive rest between bouts. In addition, to achieve the second aim, the active break will be designed taking into account the intensity of physical activity that proves to have the greatest benefits on cognition and well-being.

Locations

Country Name City State
Spain University Jaume I Castelló de la Plana Castellón

Sponsors (1)

Lead Sponsor Collaborator
Universitat Jaume I

Country where clinical trial is conducted

Spain, 

References & Publications (9)

Brickenkamp, R., Schmidt-Atzert, L., & Liepmann, D. d2-R. Test de Atención - Revisado. TEA Ediciones. 2022.

Chan JSY, Liu G, Liang D, Deng K, Wu J, Yan JH. Special Issue - Therapeutic Benefits of Physical Activity for Mood: A Systematic Review on the Effects of Exercise Intensity, Duration, and Modality. J Psychol. 2019;153(1):102-125. doi: 10.1080/00223980.2018.1470487. Epub 2018 Oct 15. — View Citation

Diener E. Subjective well-being. Psychol Bull. 1984 May;95(3):542-75. No abstract available. — View Citation

Erickson KI, Hillman C, Stillman CM, Ballard RM, Bloodgood B, Conroy DE, Macko R, Marquez DX, Petruzzello SJ, Powell KE; FOR 2018 PHYSICAL ACTIVITY GUIDELINES ADVISORY COMMITTEE*. Physical Activity, Cognition, and Brain Outcomes: A Review of the 2018 Physical Activity Guidelines. Med Sci Sports Exerc. 2019 Jun;51(6):1242-1251. doi: 10.1249/MSS.0000000000001936. — View Citation

Leger L, Boucher R. An indirect continuous running multistage field test: the Universite de Montreal track test. Can J Appl Sport Sci. 1980 Jun;5(2):77-84. — View Citation

Ludyga S, Gerber M, Brand S, Holsboer-Trachsler E, Puhse U. Acute effects of moderate aerobic exercise on specific aspects of executive function in different age and fitness groups: A meta-analysis. Psychophysiology. 2016 Nov;53(11):1611-1626. doi: 10.1111/psyp.12736. Epub 2016 Aug 24. — View Citation

Ludyga S, Ishihara T, Kamijo K. The Nervous System as a Pathway for Exercise to Improve Social Cognition. Exerc Sport Sci Rev. 2022 Oct 1;50(4):203-212. doi: 10.1249/JES.0000000000000300. Epub 2022 Jun 24. — View Citation

Schmitt A, Upadhyay N, Martin JA, Rojas S, Struder HK, Boecker H. Modulation of Distinct Intrinsic Resting State Brain Networks by Acute Exercise Bouts of Differing Intensity. Brain Plast. 2019 Dec 26;5(1):39-55. doi: 10.3233/BPL-190081. — View Citation

Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Attention (cognition) The participants will take the d2-R test to measure their attention. The test shows different rows of randomly mixed letters from which the target symbol is a "d" with two dashes. The participants must select all the "d" with two dashes while ignoring all the other symbols. 10 minutes before and 10 minutes after the intervention protocol
Primary Positive and negative affect (wellbeing) In order to assess the positive and negative affect, the participants will take the Positive and Negative Affect Schedule (PANAS). It is a self-report measure that is made up of two mood scales, one measuring positive affect (the scores ranging from 10 to 50, with higher scores meaning better wellbeing) and the other measuring negative affect (the scores ranging from 10 to 50, with higher scores meaning worse wellbeing). 10 minutes before and 10 minutes after intervention protocol
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