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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04860128
Other study ID # CE022102
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 28, 2021
Est. completion date June 25, 2022

Study information

Verified date September 2023
Source Universidad Católica San Antonio de Murcia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The rapid development of new technologies could be one of the causes that has favored changes in the lifestyle habits of young people. Research carried out to date shows that new technologies could be useful in increasing levels of physical activity and motivation to practice sports. However, these studies have major limitations that make it difficult to generalize the results. The objectives of the present project are: 1) to determine the influence of the use of new technologies on the levels of sports practice and the physical and psychological health of adolescents; 2) to analyze the effects of a physical-sports activity program that integrates new technologies through mobile applications related to physical exercise on the level of physical activity and the physical and psychological health of adolescents; and 3) to analyze the adherence that this type of program generates in the medium term in adolescents as a function of age and gender. The project will be divided into two phases. In the first phase, 500 students from the centers of Compulsory Secondary Education will be included, who will undergo physical tests, questionnaires related to sports practice and physical and psychological health, and an anthropometric assessment. In the second phase, an intervention will be carried out with four experimental groups and a control group. The four experimental groups will use different technological applications outside school hours for 12 weeks. Participants will keep a weekly record of physical activity and pre-, post and re-test measurements will be taken to evaluate the efficacy of the sports technology applications in increasing and maintaining physical activity.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date June 25, 2022
Est. primary completion date July 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 16 Years
Eligibility Inclusion Criteria: - Be a student of compulsory secondary education - Not present any disease or surgical operation that would prevent the performance of the physical tests or the follow-up of the established intervention. - Complete the questionnaires provided and carry out the established tests in their entirety - Have access to any mobile device that allows access to the technological sports applications used in the intervention. Exclusion Criteria: - Failure to complete the questionnaires provided and/or to take the prescribed tests in their entirety - Failure to complete scheduled intervention activities.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sports technology application
Each of the intervention groups will use in after-school hours a different mobile app for 12 weeks, with a frequency and duration of 60 minutes of training, at least three times a week. A weekly record will be kept by the adolescents in which they will have to indicate the weekly practice frequency, the duration of the activity and the kilometers covered through a report that the adolescents will deliver to the teacher at the end of each week.

Locations

Country Name City State
Spain Universidad Católica San Antonio Murcia

Sponsors (1)

Lead Sponsor Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Use of internet (CERI Questionnaire) To measure the frequency of Internet use through new communication technologies, the CERI questionnaire (Fargues et al. 2009) will be used, which includes 10 questions rated on a scale of 1 to 4, with 1 being "almost never" and 4 "almost always". Through study completion, an average of 1 year
Primary Use of mobile phone (CERM Questionnaire) To measure the frequency of cell phone use, regardless of whether it is for social networks, video games, etc., the CERM questionnaire (Fargues et al. 2009) will be used, which includes 10 questions rated on a scale of 1 to 4, with 1 being "almost never" and 4 being "almost always". Through study completion, an average of 1 year
Primary Satisfaction with life (Life Satisfaction Scale) Life satisfaction is defined as a person's overall evaluation of his or her life. The person examines the tangible aspects of his or her life and compares them with a standard or criterion chosen by him or her, arriving at a judgment about satisfaction with his or her life (Pavot et al., 1991). Thus, judgments about satisfaction depend on the comparisons that the subject makes between the circumstances of his or her life and a standard that he or she considers appropriate. The life satisfaction scale (Diener et al., 1985) provides information on feelings of happiness, feelings of loneliness and satisfaction in school among adolescents, obtaining an overall assessment of life satisfaction. The scale is composed of five questions that are answered on a scale of 1 to 5, with 1 being "strongly disagree" and 5 "strongly agree". A higher score indicates greater satisfaction with life. Through study completion, an average of 1 year
Primary Physical Activity Level (International Physical Activity Questionnaire for Adolescents) The PAQ-A (Martínez-Gómez et al., 2009) will be used to establish the level of sports practice of the adolescents. This questionnaire includes eleven questions related to the practice of physical activity in school, after school, household chores and travel. The questionnaire makes it possible to classify adolescents as inactive or active (light, moderate or vigorous intensity). Through study completion, an average of 1 year
Primary Satisfaction of basic psychological needs (Psychological Need Satisfaction in Exercise Scale) Considering that the basic psychological needs are 3: competence, autonomy and social relationships, the Psychological Need Satisfaction in Exercise Scale (Wilson et al., 2006), composed of eighteen items (six for each of the dimensions) will be used to assess the degree of satisfaction with these basic psychological needs. For its completion, a scale of 1 to 6 will be used, with 1 being "totally false" and 6 "totally true". Through study completion, an average of 1 year
Primary Back pain (Nordic Questionnaire) Spinal pathologies, including back pain, are among the most common in recent decades, due to the lack of postural hygiene caused by postures maintained over time. Back pain refers to any of the areas that make up the back (cervical, dorsal, lumbar and shoulder areas). With the Nordic Questionnaire (Martínez and Alvarado, 2017), the aim is to obtain information on the regions in which adolescents present back pain. For this purpose, the questionnaire includes images that specify the place to which each region of the back refers, and questions related to the decrease in autonomy caused by pain in those regions. Through study completion, an average of 1 year
Primary Mediterranean Diet Quality (KIDMED Questionnaire) The KIDMED questionnaire (Serra-Majem et al., 2004) will be used to establish the level of adherence of adolescents to the Mediterranean diet. It consists of 16 questions that are scored with a value of -1 if they denote a negative connotation with respect to the Mediterranean diet, or with a +1 if they are positive in relation to the diet. The index ranges from 0 to 12 points and the results are classified as: optimal Mediterranean diet (>8 points), requires improvement to adjust intake to Mediterranean patterns (4-7 points), and very low diet quality (= 3 points). The questions included in the questionnaire are related to the main foods included in this type of diet (fruit, vegetables, bread, etc.). Through study completion, an average of 1 year
Primary Physical condition (Maximal oxygen consumption) The 20-m shuttle run test evaluates maximal aerobic capacity by means of an incremental 20-meter out-and-back test. The initial speed of the test is 8.5 km/h and is increased every minute by an audible signal. The test ends when the subject stops or fails to reach the reference line two consecutive times. The speed recorded is the speed reached in the last stage that the subject is able to complete. Through the equations of Leger, Mercier, Gadoury and Lambert (1988) the reference value of the subject's VO2 max. is obtained. Through study completion, an average of 1 year
Primary Physical condition (Handgrip Strength) The test will provide information about the isometric force (kg) that the participant is able to develop with the forearm musculature. For this purpose, a digital dynamometer with manual grip (5030J1, Jamar ®, Sammons Preston, United Kingdom) will be used. Prior to the execution, the instrument will be adjusted according to the age of the player and the length of his/her hand. Two measurements will be taken with each arm, with a one minute rest between them. The participant must hold the dynamometer with the executing hand and the arm extended along the torso, without contacting it, and produce the maximum force possible (Rojas, Vázquez, Sánchez, Banik, & Argáez, 2012; Valdes & Yanci, 2016). Manual grip strength determined by dynamometer is significantly associated with proper cardiovascular health in adolescents, so its analysis is of interest as part of an assessment of global physical fitness (García-Hermoso et al., 2019). Through study completion, an average of 1 year
Primary Physical condition (Lower extremity muscle strength) The countermovement jump test (CMJ) will be used to measure this variable. This test provides information on the explosive strength of the lower body. The CMJ is a vertical jump that begins with the subject in a standing position, followed by knee flexion to a position of approximately 90 degrees, and a rapid extension of the knees to perform a jump in which the maximum height is reached. It should be noted that there is no stop in the knee flexion position since the intention is to take advantage of the explosive elastic reflex energy of the movement. The subjects will perform two repetitions of the jump 2 minutes apart. A MuscleLab force platform (Ergotest Innovation S.A., Norway) will be used to record the data, which will measure the time of flight from the time the subject takes off from the platform to the time the subject re-enters contact with the platform. Through study completion, an average of 1 year
Primary Physical condition (Hamstrings Flexibility) The sit-and-reach test will be used. A 30-centimeter measuring box (Finder Flex-Tester, Novel Products, USA) with a millimeter ruler is required. In the initial position, the subject should be in a seated position, with knees fully extended, feet hip-width apart and soles of the feet perpendicular to the floor and in contact with the box. The subject will be asked to place one hand on top of the other, with the palms of the hands facing downward and the fingers stretched out. The subject will perform a neck flexion to bring the chin to the chest and a trunk flexion with the knees fully stretched and without ballistic movements, trying to reach the greatest possible distance and maintaining the posture for 3 seconds. The distance will be measured in centimeters and the value 0 will correspond to the tangent of the soles of the feet, the values being positive when this distance is exceeded, and negative when it is not reached. Through study completion, an average of 1 year
Primary Anthropometric Variables (Height) To measure height, a SECA measuring rod should be used. Adolescents should stand barefoot with their backs against the measuring rod, heels of their feet together and their gaze straight ahead. Measurements will be obtained in centimeters and will be repeated 2 times for each subject. A third measurement will only be taken if the difference between the first and second measurement is greater than 1%. Through study completion, an average of 1 year
Primary Anthropometric Variables (Weight) A Tanita BC 418-MA Segmental scale (Tanita, Tokyo) will be used to measure body weight. The subject will step on the scale with both feet inside the scale and looking straight ahead, without leaning the body. Values will be obtained in kilograms and two measurements will be carried out on each subject. If the difference between both measurements is greater than 1%, a third measurement will be taken. Through study completion, an average of 1 year
Primary Anthropometric Variables (Fat mass) To obtain the fat mass, it will be necessary to previously measure the triceps, thigh and leg folds, and the waist, hip, relaxed arm, thigh and leg perimeters. For these previous measurements, two measurements will be taken in each subject, and a third measurement will be necessary if the difference between the first two is greater than 5%. Once the values of the previous measurements have been obtained, the fat mass can be calculated using the formula of Slaughter et al. (1988) Through study completion, an average of 1 year
Primary Anthropometric Variables (Fat-free mass) To obtain the fat-free mass, it will be necessary to previously measure the triceps, thigh and leg folds, and the perimeters of the waist, hip, relaxed arm, thigh and leg. For these previous measurements, two measurements will be taken in each subject, and a third measurement will be necessary if the difference between the first two is greater than 5%. Once the values of the previous measurements have been obtained, the-fat free mass can be calculated using the formula of Poortmans et al. (2005) Through study completion, an average of 1 year
Primary Anthropometric Variables (BMI) Previously obtained height and weight measurements will be used to establish the BMI. The formula used will be weight/height^2, and the result will be obtained in kg/m^2. This index is commonly used and is related to metabolic and cardiovascular diseases in adolescents and adults. Through study completion, an average of 1 year
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