Sedentary BehaviorOBAFITNCT04994340
Physical Activity Observatory of Castilla-La Mancha
An observational study of Sedentary Behavior and Exercise, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
The OBAFIT project aims to examine the patterns of physical activity, sedentary activity and health-related physical fitness of the boys and girls enrolled in schools of Primary Education and Secondary Education in Castilla-La Mancha (Spain). The design of the project is observational/cross-sectional. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Exercise, Physical Fitness
- How many people
- 3,280 participants
- Where
- 1 siteSpain
- Study dates
- 8 Sep 2017to 23 Jun 2022
- Phase
- Observational
- 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 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Boys and girls aged 6 to 16 years enrolled in Primary and Secondary Education schools in Castilla La Mancha.
Who may be able to join
- Be enrolled in any school in Castilla-La Mancha (primary or secondary, public or private, rural or urban).
Who cannot join
- Temporary injury or disability that prevents physical testing.
- Clinical diagnosis of diabetes or diseases not related to nutrition.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad Castilla-La Mancha
Toledo, 45004
Javier Valenciano, PhD, 925268800 ext. +34, javier.valenciano@uclm.es
Alejandro Jiménez-Loaisa, 648622088 ext. +34, alejandro.jloaisa@uclm.es
About this study
The OBAFIT project aims to examine the patterns of physical activity, sedentary activity and health-related physical fitness of the boys and girls enrolled in schools of Primary Education and Secondary Education in Castilla-La Mancha (Spain). The design of the project is observational/cross-sectional. Through an epidemiological orientation, it proposes a representative sampling of a multistage type of the Castilian-La Mancha population aged 6 to 16 years. The subjects that will make up the sample will be selected from among the 724 Castilian-La Mancha schools with teachings in the Primary Education stage, and among 373 Secondary Education schools. To ensure the heterogeneity of the population, both public and private centers will be selected, and proportionally between centers that have Healthy School Programs (PES) from those that do not. The sample will be multistage, randomized and stratified according to province (Albacete, Ciudad Real, Cuenca, Guadalajara and Toledo), area (urban, semi-urban, rural), sex (men, women) and age (one group for each age group).
Read the detailed description
The OBAFIT project was designed to provide a public tool where PA habits, sedentary behaviors and the health-related physical fitness of school children from Castilla-La Mancha (a Spanish region) could be visualized. OBAFIT also allows physical education teachers at participating schools to monitor and observe the evolution of these variables in their students.
For this, the schooling data provided by the Consejería de Educación, Cultura y Deportes de la Junta de Comunidades de Castilla-La Mancha (Ministry of Education, Culture and Sports of the Community Board of Castilla-La Mancha) are considered: the population enrolled in the region from the first to the sixth year of Primary Education amounts to 131,903 students (63,488 girls; 68,415 boys) distributed in the five provinces (Albacete 24,143; Ciudad Real 31,053; Cuenca 11,001; Guadalajara 17,560; Toledo 48,146) both in public (106,366) and private (25,537) schools.
In the case of Secondary Education and the first year of high school, the number of students stands at 98,745 (50,807 men and 49,267 women) from the five provinces of the region (Albacete 19,016; Ciudad Real 23,599; Cuenca 8,971; Guadalajara 12,827; Toledo 34,332) of public centers (80,996) and private (19,078).
The sample size, calculated through the Edidat 4.2 software, is 631 subjects for the Primary sample and 631 for the Secondary sample (assuming normal distribution). A confidence level of 95% and a margin of error of 3% have been considered, and the CVR associated with low CRC with a prevalence of 18% is assumed as the parameter of greater variance. If the same level of confidence and margin of error for both sexes are considered, the sample would amount to 1,262 for each educational level. Assuming a non-response rate of 30%, the final sample size is estimated at 1640 students in Primary Education and 1640 for Secondary Education.
The participants that will make up the sample will be selected from the 724 Castilian-La Mancha schools with education in the Primary Education stage, and from 373 Secondary Education centers. Both public and private centers will be selected. The sample will be multistage, randomized and stratified according to province (Albacete, Ciudad Real, Cuenca, Guadalajara and Toledo), area (urban, semi-urban, rural), gender (men, women) and age (one group for each section of age).
Once the sample size has been determined, a lottery of schools classified based on the aforementioned criteria is carried out, considering in all cases the proportionality in the number of students. For this, a multistage method with proportional probability will be used using SPSS 24.0 software. Approximately 48 centers for Primary Education and 55 for Secondary Education will be selected, taking into account that there are 6 Primary courses and 4 in E.S.O. (Spanish system) in addition to 1st year of high school In the selected schools, three boys and three girls will be randomly chosen per group-class and level, on which the different instruments will be applied. A priori, due to pedagogical and operational issues in the administration, proportional age preselection will not be carried out (for the same group-class). Since all students in the same class-group will have the same probability of being selected, the age and sex quotas will be corrected at the end of data collection by a weighting system.
- Conditions
- Sedentary Behavior, Exercise, Physical Fitness
- Keywords
- Childhood, Physical activity, Health, School, Surveillance
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children | From a cross-sectional perspective, children will fill out questionnaires related to their subjective physical activity levels (PAQ-C), levels of sedentary activity (YLSBQ), and socio-economic status (Family Affluence Scale III) during school hours. Two sessions of physical education will be used to measure the health-related physical fitness of children through the ALPHA-Fitness battery test. The sequence to administer this battery will be: 1. Weight and height (BMI); 2. Waist circumference; 3. Skin folds; 4. Hand grip strength, long jump with feet together, and 4x10 m shuttle run test (these tests could be carried out alternately or simultaneously since there will always be 2 or more evaluators); 5. 20 m Course Navette test. | |
| Adolescents | From a cross-sectional perspective, adolescents will fill out questionnaires related to their subjective physical activity levels (PAQ-A), levels of sedentary activity (YLSBQ), and socio-economic status (Family Affluence Scale III) during school hours. Two sessions of physical education will be used to measure the health-related physical fitness of adolescents through the ALPHA-Fitness battery test. The sequence to administer this battery will be: 1. Weight and height (BMI); 2. Waist circumference; 3. Skin folds; 4. Hand grip strength, long jump with feet together, and 4x10 m shuttle run test (these tests could be carried out alternately or simultaneously since there will always be 2 or more evaluators); 5. 20 m Course Navette test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective physical activity levels
Physical activity assessed by self-report (PAQ-C or PAQ-A). The scales ranged from 0 to 5, where higher values indicate greater levels of physical activity.
Measured: 2017/2018 to 2021/2022
Device-measured physical activity levels
Physical activity assessed by accelerometer (Measure carried out only in those schools that give consent)
Measured: 2017/2018 to 2021/2022
Sedentary behavior
Sedentary behavior assessed by self-report (YLSBQ)
Measured: 2017/2018 to 2021/2022
Sedentary behavior
Adolescents' sedentary behaviors assessed by self-report (ASAQ)
Measured: 2017/2018 to 2021/2022
Health-related physical fitness
Health-related physical fitness assessed by the ALPHA-FITNESS test battery
Measured: 2017/2018 to 2021/2022
Secondary outcomes (1)
Socioeconomic status
Socioeconomic status assessed by the Family Affluence Scale III. The scale ranged from 0 to 13, where higher values indicate a greater socioeconomic status.
Measured: 2017/2018 to 2021/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start8 Sep 2017
- Primary completion23 Jun 2018
- Study completion23 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Sedentary BehaviorStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Consejería de Educación, Cultura y Deportes de Castilla-La Mancha, Dirección General de Juventud y Deportes de Castilla-La Mancha
- Responsible party
- Principal investigator, Javier Valenciano, University of Castilla-La Mancha
- Investigators
- Javier Valenciano, PhD, Principal investigator, University of Castilla-La ManchaJuan Gregorio Fernández-Bustos, PhD, Principal investigator, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994340
- Sponsor's protocol ID
- 2020/01/007
- Acronym
- OBAFIT
- Status last verified
- Aug 2021
- First submitted
- 28 Jul 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Poitras VJ, Gray CE, Borghese MM, Carson V, Chaput JP, Janssen I, Katzmarzyk PT, Pate RR, Connor Gorber S, Kho ME, Sampson M, Tremblay MS. Systematic review of the relationships between objectively measured physical activity and health indicators in school-aged children and youth. Appl Physiol Nutr Metab. 2016 Jun;41(6 Suppl 3):S197-239. doi: 10.1139/apnm-2015-0663.
PubMed 27306431Biddle SJ, Gorely T, Pearson N, Bull FC. An assessment of self-reported physical activity instruments in young people for population surveillance: Project ALPHA. Int J Behav Nutr Phys Act. 2011 Jan 2;8:1. doi: 10.1186/1479-5868-8-1.
PubMed 21194492Benitez-Porres J, Lopez-Fernandez I, Raya JF, Alvarez Carnero S, Alvero-Cruz JR, Alvarez Carnero E. Reliability and Validity of the PAQ-C Questionnaire to Assess Physical Activity in Children. J Sch Health. 2016 Sep;86(9):677-85. doi: 10.1111/josh.12418.
PubMed 27492937Cain KL, Sallis JF, Conway TL, Van Dyck D, Calhoon L. Using accelerometers in youth physical activity studies: a review of methods. J Phys Act Health. 2013 Mar;10(3):437-50. doi: 10.1123/jpah.10.3.437.
PubMed 23620392Hidding LM, Chinapaw MJM, van Poppel MNM, Mokkink LB, Altenburg TM. An Updated Systematic Review of Childhood Physical Activity Questionnaires. Sports Med. 2018 Dec;48(12):2797-2842. doi: 10.1007/s40279-018-0987-0.
PubMed 30298479Ortega FB, Ruiz JR, Castillo MJ, Moreno LA, Gonzalez-Gross M, Warnberg J, Gutierrez A; Grupo AVENA. [Low level of physical fitness in Spanish adolescents. Relevance for future cardiovascular health (AVENA study)]. Rev Esp Cardiol. 2005 Aug;58(8):898-909. Spanish.
PubMed 16053823Ruiz JR, Espana Romero V, Castro Pinero J, Artero EG, Ortega FB, Cuenca Garcia M, Jimenez Pavon D, Chillon P, Girela Rejon MJ, Mora J, Gutierrez A, Suni J, Sjostrom M, Castillo MJ. [ALPHA-fitness test battery: health-related field-based fitness tests assessment in children and adolescents]. Nutr Hosp. 2011 Nov-Dec;26(6):1210-4. doi: 10.1590/S0212-16112011000600003. Spanish.
PubMed 22411362Marasso D, Lupo C, Collura S, Rainoldi A, Brustio PR. Subjective versus Objective Measure of Physical Activity: A Systematic Review and Meta-Analysis of the Convergent Validity of the Physical Activity Questionnaire for Children (PAQ-C). Int J Environ Res Public Health. 2021 Mar 25;18(7):3413. doi: 10.3390/ijerph18073413.
PubMed 33806106
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Observatory of Castilla-La Mancha
- ClinicalTrials.gov ID
- NCT04994340
- Acronym / sponsor ID
- OBAFIT / 2020/01/007
- Conditions
- Sedentary Behavior, Exercise, Physical Fitness
- Keywords
- Childhood, Physical activity, Health, School, Surveillance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,280 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Consejería de Educación, Cultura y Deportes de Castilla-La Mancha, Dirección General de Juventud y Deportes de Castilla-La Mancha
- Study start
- 8 Sep 2017 (actual)
- Primary completion
- 23 Jun 2018 (actual)
- Study completion
- 23 Jun 2022 (estimated)
- First posted
- 6 Aug 2021 (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.
The OBAFIT project aims to examine the patterns of physical activity, sedentary activity and health-related physical fitness of the boys and girls enrolled in schools of Primary Education and Secondary Education in Castilla-La Mancha (Spain). The design of the project is observational/cross-sectional. Through an epidemiological orientation, it proposes a representative sampling of a multistage type of the Castilian-La Mancha population aged 6 to 16 years. The subjects that will make up the sample will be selected from among the 724 Castilian-La Mancha schools with teachings in the Primary Education stage, and among 373 Secondary Education schools. To ensure the heterogeneity of the population, both public and private centers will be selected, and proportionally between centers that have Healthy School Programs (PES) from those that do not. The sample will be multistage, randomized and stratified according to province (Albacete, Ciudad Real, Cuenca, Guadalajara and Toledo), area (urban, semi-urban, rural), sex (men, women) and age (one group for each age group).
Detailed description
The OBAFIT project was designed to provide a public tool where PA habits, sedentary behaviors and the health-related physical fitness of school children from Castilla-La Mancha (a Spanish region) could be visualized. OBAFIT also allows physical education teachers at participating schools to monitor and observe the evolution of these variables in their students.
For this, the schooling data provided by the Consejería de Educación, Cultura y Deportes de la Junta de Comunidades de Castilla-La Mancha (Ministry of Education, Culture and Sports of the Community Board of Castilla-La Mancha) are considered: the population enrolled in the region from the first to the sixth year of Primary Education amounts to 131,903 students (63,488 girls; 68,415 boys) distributed in the five provinces (Albacete 24,143; Ciudad Real 31,053; Cuenca 11,001; Guadalajara 17,560; Toledo 48,146) both in public (106,366) and private (25,537) schools.
In the case of Secondary Education and the first year of high school, the number of students stands at 98,745 (50,807 men and 49,267 women) from the five provinces of the region (Albacete 19,016; Ciudad Real 23,599; Cuenca 8,971; Guadalajara 12,827; Toledo 34,332) of public centers (80,996) and private (19,078).
The sample size, calculated through the Edidat 4.2 software, is 631 subjects for the Primary sample and 631 for the Secondary sample (assuming normal distribution). A confidence level of 95% and a margin of error of 3% have been considered, and the CVR associated with low CRC with a prevalence of 18% is assumed as the parameter of greater variance. If the same level of confidence and margin of error for both sexes are considered, the sample would amount to 1,262 for each educational level. Assuming a non-response rate of 30%, the final sample size is estimated at 1640 students in Primary Education and 1640 for Secondary Education.
The participants that will make up the sample will be selected from the 724 Castilian-La Mancha schools with education in the Primary Education stage, and from 373 Secondary Education centers. Both public and private centers will be selected. The sample will be multistage, randomized and stratified according to province (Albacete, Ciudad Real, Cuenca, Guadalajara and Toledo), area (urban, semi-urban, rural), gender (men, women) and age (one group for each section of age).
Once the sample size has been determined, a lottery of schools classified based on the aforementioned criteria is carried out, considering in all cases the proportionality in the number of students. For this, a multistage method with proportional probability will be used using SPSS 24.0 software. Approximately 48 centers for Primary Education and 55 for Secondary Education will be selected, taking into account that there are 6 Primary courses and 4 in E.S.O. (Spanish system) in addition to 1st year of high school In the selected schools, three boys and three girls will be randomly chosen per group-class and level, on which the different instruments will be applied. A priori, due to pedagogical and operational issues in the administration, proportional age preselection will not be carried out (for the same group-class). Since all students in the same class-group will have the same probability of being selected, the age and sex quotas will be corrected at the end of data collection by a weighting system.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children | – | –From a cross-sectional perspective, children will fill out questionnaires related to their subjective physical activity levels (PAQ-C), levels of sedentary activity (YLSBQ), and socio-economic status (Family Affluence Scale III) during school hours. Two sessions of physical education will be used to measure the health-related physical fitness of children through the ALPHA-Fitness battery test. The sequence to administer this battery will be: 1. Weight and height (BMI); 2. Waist circumference; 3. Skin folds; 4. Hand grip strength, long jump with feet together, and 4x10 m shuttle run test (these tests could be carried out alternately or simultaneously since there will always be 2 or more evaluators); 5. 20 m Course Navette test. |
| Adolescents | – | –From a cross-sectional perspective, adolescents will fill out questionnaires related to their subjective physical activity levels (PAQ-A), levels of sedentary activity (YLSBQ), and socio-economic status (Family Affluence Scale III) during school hours. Two sessions of physical education will be used to measure the health-related physical fitness of adolescents through the ALPHA-Fitness battery test. The sequence to administer this battery will be: 1. Weight and height (BMI); 2. Waist circumference; 3. Skin folds; 4. Hand grip strength, long jump with feet together, and 4x10 m shuttle run test (these tests could be carried out alternately or simultaneously since there will always be 2 or more evaluators); 5. 20 m Course Navette test. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Boys and girls aged 6 to 16 years enrolled in Primary and Secondary Education schools in Castilla La Mancha.
Key inclusion criteria (1 listed)
- Be enrolled in any school in Castilla-La Mancha (primary or secondary, public or private, rural or urban).
Key exclusion criteria (2 listed)
- Temporary injury or disability that prevents physical testing.
- Clinical diagnosis of diabetes or diseases not related to nutrition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subjective physical activity levels
Time frame: 2017/2018 to 2021/2022
Physical activity assessed by self-report (PAQ-C or PAQ-A). The scales ranged from 0 to 5, where higher values indicate greater levels of physical activity.
Device-measured physical activity levels
Time frame: 2017/2018 to 2021/2022
Physical activity assessed by accelerometer (Measure carried out only in those schools that give consent)
Sedentary behavior
Time frame: 2017/2018 to 2021/2022
Sedentary behavior assessed by self-report (YLSBQ)
Sedentary behavior
Time frame: 2017/2018 to 2021/2022
Adolescents' sedentary behaviors assessed by self-report (ASAQ)
Health-related physical fitness
Time frame: 2017/2018 to 2021/2022
Health-related physical fitness assessed by the ALPHA-FITNESS test battery
1 secondary outcome
Socioeconomic status
Time frame: 2017/2018 to 2021/2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Background: PubMed 27306431Poitras VJ, Gray CE, Borghese MM, Carson V, Chaput JP, Janssen I, Katzmarzyk PT, Pate RR, Connor Gorber S, Kho ME, Sampson M, Tremblay MS. Systematic review of the relationships between objectively measured physical activity and health indicators in school-aged children and youth. Appl Physiol Nutr Metab. 2016 Jun;41(6 Suppl 3):S197-239. doi: 10.1139/apnm-2015-0663.
- Background: PubMed 21194492Biddle SJ, Gorely T, Pearson N, Bull FC. An assessment of self-reported physical activity instruments in young people for population surveillance: Project ALPHA. Int J Behav Nutr Phys Act. 2011 Jan 2;8:1. doi: 10.1186/1479-5868-8-1.
- Background: PubMed 27492937Benitez-Porres J, Lopez-Fernandez I, Raya JF, Alvarez Carnero S, Alvero-Cruz JR, Alvarez Carnero E. Reliability and Validity of the PAQ-C Questionnaire to Assess Physical Activity in Children. J Sch Health. 2016 Sep;86(9):677-85. doi: 10.1111/josh.12418.
- Background: PubMed 23620392Cain KL, Sallis JF, Conway TL, Van Dyck D, Calhoon L. Using accelerometers in youth physical activity studies: a review of methods. J Phys Act Health. 2013 Mar;10(3):437-50. doi: 10.1123/jpah.10.3.437.
- Background: PubMed 30298479Hidding LM, Chinapaw MJM, van Poppel MNM, Mokkink LB, Altenburg TM. An Updated Systematic Review of Childhood Physical Activity Questionnaires. Sports Med. 2018 Dec;48(12):2797-2842. doi: 10.1007/s40279-018-0987-0.
- Background: PubMed 16053823Ortega FB, Ruiz JR, Castillo MJ, Moreno LA, Gonzalez-Gross M, Warnberg J, Gutierrez A; Grupo AVENA. [Low level of physical fitness in Spanish adolescents. Relevance for future cardiovascular health (AVENA study)]. Rev Esp Cardiol. 2005 Aug;58(8):898-909. Spanish.
- Background: PubMed 22411362Ruiz JR, Espana Romero V, Castro Pinero J, Artero EG, Ortega FB, Cuenca Garcia M, Jimenez Pavon D, Chillon P, Girela Rejon MJ, Mora J, Gutierrez A, Suni J, Sjostrom M, Castillo MJ. [ALPHA-fitness test battery: health-related field-based fitness tests assessment in children and adolescents]. Nutr Hosp. 2011 Nov-Dec;26(6):1210-4. doi: 10.1590/S0212-16112011000600003. Spanish.
- Background: PubMed 33806106Marasso D, Lupo C, Collura S, Rainoldi A, Brustio PR. Subjective versus Objective Measure of Physical Activity: A Systematic Review and Meta-Analysis of the Convergent Validity of the Physical Activity Questionnaire for Children (PAQ-C). Int J Environ Res Public Health. 2021 Mar 25;18(7):3413. doi: 10.3390/ijerph18073413.
- OBAFIT websiteLink provided by the sponsor.
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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.
Javier Valenciano, PhD principal investigator
University of Castilla-La Mancha
Juan Gregorio Fernández-Bustos, PhD principal investigator
University of Castilla-La Mancha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedentary Behavior and Exercise, run by University of Castilla-La Mancha 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 2 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 6 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javier Valenciano, PhD (925268800 ext. +34, javier.valenciano@uclm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective physical activity levels (time frame: 2017/2018 to 2021/2022). The study lists 5 primary outcomes in all. 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 NCT04994340, which also lists 8 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 6 Aug 2021.