Physical FitnessNCT05085899
Physical Fitness Normative Values Among School Going Children
An observational study of Physical Fitness and Cardiorespiratory Fitness, run by Riphah International University at 1 site in Pakistan.
Trial summary
Physical fitness is state of health and wellbeing, it determines ability of body to perform sports or daily physical activities. Physical fitness is related to our cardiorespiratory fitness level, as cardiorespiratory fitness levels used for decreasing chronic diseases, promoting overall cardiovascular and general… Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Fitness, Cardiorespiratory Fitness
- How many people
- 500 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2021to 1 Dec 2021
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Physical fitness will be measured by ALPHA health related fitness test battery in children and adults. Following tests will be used to determine normative values of physical fitness such as, 1. Morphological components 2. Waist circumference 3. Subscapular skinfold 4. Triceps skinfold. 5. Musculoskeletal component 6. Standing broad jump 7. 4x10 m run test 8. 20m shuttle test
Who may be able to join
- School going children of age 10-18 years,
Who cannot join
- Mentally unstable children
- Children having any disorders
Trial locations and contacts
1 site in 1 country.
About this study
Physical fitness is state of health and wellbeing, it determines ability of body to perform sports or daily physical activities. Physical fitness is related to our cardiorespiratory fitness level, as cardiorespiratory fitness levels used for decreasing chronic diseases, promoting overall cardiovascular and general body health, decreasing the chance of developing disorders due to poor physical fitness. Different tests will be used for the measurement of physical fitness in school going children such as 1. height and weight, 2.waist circumference, 3.triceps skinfold thickness, 4.subscapular skinfold thickness, 5.standing long jump test, 6.handgrip strength test, 7. 20 m shuttle run test, 8. 4x10 m shuttle run test.
This study will be Cross-sectional study and will be conducted in schools in order to determine physical fitness level in school going children and adolescents between age 10-17-year-old. Data will be collected by non-probability convenience sampling technique. Early determination of physical fitness level in school going children will be helpful, to promote their health status and to prevent the incidence of cardiovascular disorders.
Read the detailed description
Evidence shows that low physical fitness level and cardiorespiratory level are strongly and independently associated with high risk of cardiovascular disorders, diabetes, mental health, stroke other risk factors and comorbidities. In children and adolescents, peak oxygen uptake (VO2peak) is the most researched physiological variable in pediatric exercise physiology for its association with cardio-metabolic risk factors and other health-related variables . Children's health and well-being is highly correlated with their physical fitness. Recently published studies indicate that low levels of physical fitness (e.g., cardiorespiratory fitness, muscular endurance/power) are associated with an elevated risk of developing adverse physiological events (e.g., unbalanced body mass index, waist circumference, systolic blood pressure, plasma glucose, lipoprotein cholesterol, insulin resistance) in school-aged students.
Physical fitness is usually determined in school-aged children using health-related physical fitness batteries (i.e., field tests). Compared to more sophisticated laboratory-based test equipment, field tests are easy-to-administer, involve minimal equipment and personnel, demonstrate good validity and reliability and a large number of subjects can be tested in a relatively small amount of time. Normative data derived from field tests have previously been used to identify subjects for health/talent promotion or to provide current objective recommendations for the assessment of physical fitness during physical education.
In this study investigator will determine physical fitness normative values in school going children, in order to determine present health status which will reduce the incidence of future occurrence of cardiovascular disorders. Present health status is strong predictor of future cardiovascular disorders.
- Conditions
- Physical Fitness, Cardiorespiratory Fitness
- Keywords
- Normative values, Cardiorespiratory Fitness, School Going Children
What is being measured
The primary outcome is the main question the study is designed to answer.
ALPHA Health-Related Fitness Test Battery for Children and Adolescents
The ALPHA fitness test battery is a developed tool to provide a set of valid, reliable, feasible and safe field-based fitness tests for the assessment of health-related physical fitness in children and adolescents.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start1 May 2021
- Primary completion1 Nov 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Physical FitnessStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danish Hassan, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085899
- Sponsor's protocol ID
- RiphahIU Sana Manzoor
- Status last verified
- Apr 2022
- First submitted
- 20 Aug 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramos-Sepulveda JA, Ramirez-Velez R, Correa-Bautista JE, Izquierdo M, Garcia-Hermoso A. Physical fitness and anthropometric normative values among Colombian-Indian schoolchildren. BMC Public Health. 2016 Sep 13;16(1):962. doi: 10.1186/s12889-016-3652-2.
PubMed 27619491Lesinski M, Schmelcher A, Herz M, Puta C, Gabriel H, Arampatzis A, Laube G, Busch D, Granacher U. Maturation-, age-, and sex-specific anthropometric and physical fitness percentiles of German elite young athletes. PLoS One. 2020 Aug 13;15(8):e0237423. doi: 10.1371/journal.pone.0237423. eCollection 2020.
PubMed 32790710Ramirez-Velez R, Silva-Moreno C, Correa-Bautista JE, Gonzalez-Ruiz K, Prieto-Benavides DH, Villa-Gonzalez E, Garcia-Hermoso A. Self-Rated Health Status and Cardiorespiratory Fitness in a Sample of Schoolchildren from Bogota, Colombia. The FUPRECOL Study. Int J Environ Res Public Health. 2017 Aug 23;14(9):952. doi: 10.3390/ijerph14090952.
PubMed 28832546Thomas E, Petrigna L, Tabacchi G, Teixeira E, Pajaujiene S, Sturm DJ, Sahin FN, Gomez-Lopez M, Pausic J, Paoli A, Alesi M, Bianco A. Percentile values of the standing broad jump in children and adolescents aged 6-18 years old. Eur J Transl Myol. 2020 Jun 17;30(2):9050. doi: 10.4081/ejtm.2019.9050. eCollection 2020 Jul 13.
PubMed 32782766Godoy-Cumillaf A, Bizzozero-Peroni B, Tomkinson GR, Brazo-Sayavera J. Physical fitness of Latin America children and adolescents: a protocol for a systematic review and meta-analysis. BMJ Open. 2021 May 3;11(5):e047122. doi: 10.1136/bmjopen-2020-047122.
PubMed 33941634
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Fitness Normative Values Among School Going Children
- ClinicalTrials.gov ID
- NCT05085899
- Acronym / sponsor ID
- RiphahIU Sana Manzoor
- Conditions
- Physical Fitness, Cardiorespiratory Fitness
- Keywords
- Normative values, Cardiorespiratory Fitness, School Going Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 20 Oct 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.
Physical fitness is state of health and wellbeing, it determines ability of body to perform sports or daily physical activities. Physical fitness is related to our cardiorespiratory fitness level, as cardiorespiratory fitness levels used for decreasing chronic diseases, promoting overall cardiovascular and general body health, decreasing the chance of developing disorders due to poor physical fitness. Different tests will be used for the measurement of physical fitness in school going children such as 1. height and weight, 2.waist circumference, 3.triceps skinfold thickness, 4.subscapular skinfold thickness, 5.standing long jump test, 6.handgrip strength test, 7. 20 m shuttle run test, 8. 4x10 m shuttle run test.
This study will be Cross-sectional study and will be conducted in schools in order to determine physical fitness level in school going children and adolescents between age 10-17-year-old. Data will be collected by non-probability convenience sampling technique. Early determination of physical fitness level in school going children will be helpful, to promote their health status and to prevent the incidence of cardiovascular disorders.
Detailed description
Evidence shows that low physical fitness level and cardiorespiratory level are strongly and independently associated with high risk of cardiovascular disorders, diabetes, mental health, stroke other risk factors and comorbidities. In children and adolescents, peak oxygen uptake (VO2peak) is the most researched physiological variable in pediatric exercise physiology for its association with cardio-metabolic risk factors and other health-related variables . Children's health and well-being is highly correlated with their physical fitness. Recently published studies indicate that low levels of physical fitness (e.g., cardiorespiratory fitness, muscular endurance/power) are associated with an elevated risk of developing adverse physiological events (e.g., unbalanced body mass index, waist circumference, systolic blood pressure, plasma glucose, lipoprotein cholesterol, insulin resistance) in school-aged students.
Physical fitness is usually determined in school-aged children using health-related physical fitness batteries (i.e., field tests). Compared to more sophisticated laboratory-based test equipment, field tests are easy-to-administer, involve minimal equipment and personnel, demonstrate good validity and reliability and a large number of subjects can be tested in a relatively small amount of time. Normative data derived from field tests have previously been used to identify subjects for health/talent promotion or to provide current objective recommendations for the assessment of physical fitness during physical education.
In this study investigator will determine physical fitness normative values in school going children, in order to determine present health status which will reduce the incidence of future occurrence of cardiovascular disorders. Present health status is strong predictor of future cardiovascular disorders.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Physical fitness will be measured by ALPHA health related fitness test battery in children and adults. Following tests will be used to determine normative values of physical fitness such as, 1. Morphological components 2. Waist circumference 3. Subscapular skinfold 4. Triceps skinfold. 5. Musculoskeletal component 6. Standing broad jump 7. 4x10 m run test 8. 20m shuttle test
Key inclusion criteria (1 listed)
- School going children of age 10-18 years,
Key exclusion criteria (2 listed)
- Mentally unstable children
- Children having any disorders
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
ALPHA Health-Related Fitness Test Battery for Children and Adolescents
Time frame: Day 1
The ALPHA fitness test battery is a developed tool to provide a set of valid, reliable, feasible and safe field-based fitness tests for the assessment of health-related physical fitness in children and adolescents.
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 6 Apr 2022.
- Background: PubMed 27619491Ramos-Sepulveda JA, Ramirez-Velez R, Correa-Bautista JE, Izquierdo M, Garcia-Hermoso A. Physical fitness and anthropometric normative values among Colombian-Indian schoolchildren. BMC Public Health. 2016 Sep 13;16(1):962. doi: 10.1186/s12889-016-3652-2.
- Background: PubMed 32790710Lesinski M, Schmelcher A, Herz M, Puta C, Gabriel H, Arampatzis A, Laube G, Busch D, Granacher U. Maturation-, age-, and sex-specific anthropometric and physical fitness percentiles of German elite young athletes. PLoS One. 2020 Aug 13;15(8):e0237423. doi: 10.1371/journal.pone.0237423. eCollection 2020.
- Background: PubMed 28832546Ramirez-Velez R, Silva-Moreno C, Correa-Bautista JE, Gonzalez-Ruiz K, Prieto-Benavides DH, Villa-Gonzalez E, Garcia-Hermoso A. Self-Rated Health Status and Cardiorespiratory Fitness in a Sample of Schoolchildren from Bogota, Colombia. The FUPRECOL Study. Int J Environ Res Public Health. 2017 Aug 23;14(9):952. doi: 10.3390/ijerph14090952.
- Background: PubMed 32782766Thomas E, Petrigna L, Tabacchi G, Teixeira E, Pajaujiene S, Sturm DJ, Sahin FN, Gomez-Lopez M, Pausic J, Paoli A, Alesi M, Bianco A. Percentile values of the standing broad jump in children and adolescents aged 6-18 years old. Eur J Transl Myol. 2020 Jun 17;30(2):9050. doi: 10.4081/ejtm.2019.9050. eCollection 2020 Jul 13.
- Background: PubMed 33941634Godoy-Cumillaf A, Bizzozero-Peroni B, Tomkinson GR, Brazo-Sayavera J. Physical fitness of Latin America children and adolescents: a protocol for a systematic review and meta-analysis. BMJ Open. 2021 May 3;11(5):e047122. doi: 10.1136/bmjopen-2020-047122.
- Individual participant dataSharing planned: No
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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.
Danish Hassan principal investigator
Riphah International University
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 Physical Fitness and Cardiorespiratory Fitness, run by Riphah International University at 1 site in Pakistan.
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: finished, as of the sponsor's last update on 6 Apr 2022. 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 Pakistan. 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?
ALPHA Health-Related Fitness Test Battery for Children and Adolescents (time frame: Day 1). 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 NCT05085899, which also lists 5 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 Apr 2022.