Severe Intellectual DisabilitySID-FITNCT07291115
Analysis of the Physical Fitness Development Trajectory of Children and Adolescents With Severe Intellectual Disabilities in Orphanages: A Three-year Longitudinal Follow-up Study
An observational study of Severe Intellectual Disability and Intellectual Disability, run by Xili Wen at 1 site in China.
Trial summary
This observational cohort study was designed to describe how physical fitness changes over time in children and adolescents with severe intellectual disabilities living in orphanages in China. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Severe Intellectual Disability, Intellectual Disability
- What is being tested?
- Usual institutional care and school-based physical education
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 1 Apr 2025
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents aged 7-18 years with severe intellectual disabilities who are permanent residents of four state-run orphanages located in Kaifeng and Zhengzhou (Henan Province), Wuhan (Hubei Province), and Hohhot (Inner Mongolia), China. All eligible residents meeting the inclusion criteria were invited to participate and were followed prospectively for three years with repeated physical fitness assessments. No healthy controls were included.
Who may be able to join
- Clinical diagnosis of severe intellectual disability according to national or institutional diagnostic standards.
- Aged 7 to 18 years at baseline.
- Permanent resident of one of the participating state-run orphanages in Kaifeng, Zhengzhou, Wuhan, or Hohhot, China.
- Able, with assistance if needed, to follow simple instructions and to attempt the basic physical fitness tests used in the study (height and weight, beanbag throwing, sit-ups, standing long jump, and one-leg standing).
- Written informed consent provided by the legal guardian or institutional representative in accordance with local regulations and the ethics approval.
Who cannot join
- Presence of an acute or unstable medical condition (e.g., severe cardiopulmonary disease, uncontrolled epilepsy, acute musculoskeletal injury) that would preclude safe participation in basic physical fitness testing.
- Any other condition or behavioural problem that, in the judgement of the institutional physician or investigators, would make participation unsafe or seriously interfere with completion of the assessments.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai University of Sport, School of Physical Education and Training
Shanghai, Ph.d, 200438
About this study
Official title: Analysis of the Physical Fitness Development Trajectory of Children and Adolescents With Severe Intellectual Disabilities in Orphanages: A Three-Year Longitudinal Follow-Up Study
This observational cohort study was designed to describe how physical fitness changes over time in children and adolescents with severe intellectual disabilities living in orphanages in China. A total of 132 participants aged 7-18 years were recruited from four state-run orphanages and followed prospectively for three years. At baseline and every 3 months thereafter (12 assessments in total), trained assessors measured body mass index and simple field-based fitness tests, including beanbag throwing for upper limb strength, sit-ups for core strength, standing long jump for lower limb explosive strength, and one-leg standing for static balance.
The main aim of the study is to characterize the long-term trajectories of physical fitness in this highly vulnerable population and to examine whether patterns of change differ by age group (children 7-12 years vs adolescents 13-18 years) and by sex. The findings are intended to provide evidence to guide physical education programming and health management strategies for children and adolescents with severe intellectual disabilities living in institutional care settings.
Read the detailed description
Background and Rationale Children and adolescents with severe intellectual disabilities (SID) often present with marked limitations in motor skills, low levels of physical activity, and elevated risk of secondary health problems. Those living in orphanages represent an especially vulnerable group, as they frequently have limited access to individualized physical education and health promotion programs. However, there is little longitudinal evidence describing how physical fitness develops over time in this population, and whether trajectories differ by age or sex. Understanding these patterns is essential for designing tailored interventions and for allocating rehabilitation and educational resources within institutional care settings.
Study Design and Objectives This study is a prospective, multi-site, observational cohort. The overarching objective is to analyze three-year development trajectories of physical fitness among children and adolescents with SID residing in orphanages. Specific objectives are: (1) to describe longitudinal changes in body mass index (BMI), upper limb strength, core strength, lower limb explosive strength, and static balance over 12 measurement occasions; and (2) to compare these trajectories between age groups (children 7-12 years vs adolescents 13-18 years) and between boys and girls. No experimental intervention is introduced; all participants continue to receive usual institutional care and routine school-based physical education.
Setting and Participants Participants were recruited from four state-run orphanages located in Kaifeng and Zhengzhou (Henan Province), Wuhan (Hubei Province), and Hohhot (Inner Mongolia), China. At baseline, eligible participants were 7-18 years old, had a clinical diagnosis of severe intellectual disability according to national standards, and were permanent residents of the participating orphanages. Children and adolescents with acute or unstable medical conditions that would preclude participation in basic fitness testing, or with other contraindications judged by institutional physicians, were excluded. Written informed consent was obtained from legal guardians or institutional representatives in accordance with local regulations and the ethics approval.
Assessments and Outcome Measures
Data collection started in March 2021 (T1) and continued for three years with follow-up assessments every 3 months (approximately June, September, and December each year) until March 2024, yielding 12 planned measurement time points. At each assessment, trained physical education teachers or research staff conducted standardized measurements:
Body mass index (BMI, kg/m²), calculated from height and weight.
Upper limb strength, assessed by beanbag throwing distance (meters).
Core strength, assessed by the number of correctly performed sit-ups within 1 minute.
Lower limb explosive strength, assessed by standing long jump distance (meters).
Static balance, assessed by one-leg standing time (seconds).
These measures constitute the primary and secondary outcome variables for the study. Sociodemographic characteristics (age, sex) and basic clinical information were also recorded at baseline.
Planned Data Analysis The primary analytic approach is to use generalized estimating equations (GEE) to model longitudinal changes in each fitness indicator across the 12 repeated assessments, accounting for within-subject correlation and unbalanced follow-up. Time (measurement occasion), age group at baseline (children vs adolescents), sex, and their interactions are included as predictors to estimate developmental trajectories and group differences. Analyses are conducted on the full cohort of 132 participants who contributed at least one measurement, consistent with an intention-to-follow principle for observational data.
Ethical Considerations and Status The protocol was reviewed and approved by the Ethics Committee of the Shanghai University of Physical Education and Sport (Approval No. 102772020RT054). All assessments were conducted during regular school hours using low-risk, field-based tests appropriate for children and adolescents with SID. Data collection has been completed, and this record provides a transparent description of the study procedures and analysis plan.
- Being tested
- Usual institutional care and school-based physical education
- Keywords
- Severe intellectual disability, Physical fitness, Longitudinal study, Body mass index, Motor fitness
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual institutional care and school-based physical educationOther
Participants receive the usual institutional care and routine school-based physical education provided by their orphanages. The study does not introduce any experimental intervention; physical fitness is measured repeatedly over three years under real-world conditions.
| Study group | Role | What they receive |
|---|---|---|
| Orphanage Cohort | This cohort includes all children and adolescents with severe intellectual disabilities who were permanent residents of the participating state-run orphanages in Kaifeng, Zhengzhou, Wuhan, and Hohhot, China. Participants were 7-18 years old at baseline and were followed prospectively for three years with repeated physical fitness assessments. No experimental intervention was introduced; all participants continued to receive usual institutional care and routine school-based physical education. Receives: Other: Usual institutional care and school-based physical education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal change in body mass index (BMI)
Body mass index (BMI, kg/m²) measured at each assessment using standardized height and weight measurements. BMI values will be analyzed using generalized estimating equations (GEE) to estimate the three-year trajectory and to compare patterns of change by age group (children 7-12 years vs adolescents 13-18 years) and by sex.
Measured: From baseline (March 2021) to 36 months (March 2024), assessed at 12 time points (every 3 months).
Longitudinal change in upper limb strength (beanbag throwing distance)
Upper limb strength assessed by beanbag throwing distance (meters) at each assessment. The best of two trials will be recorded. Generalized estimating equations (GEE) will be used to model three-year trajectories and to compare patterns of change by age group and sex.
Measured: From baseline (March 2021) to 36 months (March 2024), assessed at 12 time points (every 3 months).
Longitudinal change in core strength (sit-ups)
Core strength assessed by the number of correctly performed sit-ups in 1 minute at each assessment. Generalized estimating equations (GEE) will be used to model three-year trajectories and to compare patterns of change by age group and sex.
Measured: From baseline (March 2021) to 36 months (March 2024), assessed at 12 time points (every 3 months).
Longitudinal change in lower limb explosive strength (standing long jump distance)
Lower limb explosive strength assessed by standing long jump distance (meters) at each assessment. The best of two trials will be recorded. Generalized estimating equations (GEE) will be used to model three-year trajectories and to compare patterns of change by age group and sex.
Measured: From baseline (March 2021) to 36 months (March 2024), assessed at 12 time points (every 3 months).
Longitudinal change in static balance (one-leg standing time)
Static balance assessed by one-leg standing time (seconds) at each assessment. The best performance will be recorded. Generalized estimating equations (GEE) will be used to model three-year trajectories and to compare patterns of change by age group and sex.
Measured: From baseline (March 2021) to 36 months (March 2024), assessed at 12 time points (every 3 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Mar 2021
- Primary completion1 Mar 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Intellectual DisabilityStudies 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
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xili Wen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xili Wen, Shanghai University of Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291115
- Sponsor's protocol ID
- Fitness Development Trajectory
- Acronym
- SID-FIT
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Physical Fitness Development Trajectory of Children and Adolescents With Severe Intellectual Disabilities in Orphanages: A Three-Year Longitudinal Follow-Up Study
- ClinicalTrials.gov ID
- NCT07291115
- Acronym / sponsor ID
- SID-FIT / Fitness Development Trajectory
- Keywords
- Severe intellectual disability, Physical fitness, Longitudinal study, Body mass index, Motor fitness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Xili WenUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 18 Dec 2025 (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.
This observational cohort study was designed to describe how physical fitness changes over time in children and adolescents with severe intellectual disabilities living in orphanages in China. A total of 132 participants aged 7-18 years were recruited from four state-run orphanages and followed prospectively for three years. At baseline and every 3 months thereafter (12 assessments in total), trained assessors measured body mass index and simple field-based fitness tests, including beanbag throwing for upper limb strength, sit-ups for core strength, standing long jump for lower limb explosive strength, and one-leg standing for static balance.
The main aim of the study is to characterize the long-term trajectories of physical fitness in this highly vulnerable population and to examine whether patterns of change differ by age group (children 7-12 years vs adolescents 13-18 years) and by sex. The findings are intended to provide evidence to guide physical education programming and health management strategies for children and adolescents with severe intellectual disabilities living in institutional care settings.
Detailed description
Background and Rationale Children and adolescents with severe intellectual disabilities (SID) often present with marked limitations in motor skills, low levels of physical activity, and elevated risk of secondary health problems. Those living in orphanages represent an especially vulnerable group, as they frequently have limited access to individualized physical education and health promotion programs. However, there is little longitudinal evidence describing how physical fitness develops over time in this population, and whether trajectories differ by age or sex. Understanding these patterns is essential for designing tailored interventions and for allocating rehabilitation and educational resources within institutional care settings.
Study Design and Objectives This study is a prospective, multi-site, observational cohort. The overarching objective is to analyze three-year development trajectories of physical fitness among children and adolescents with SID residing in orphanages. Specific objectives are: (1) to describe longitudinal changes in body mass index (BMI), upper limb strength, core strength, lower limb explosive strength, and static balance over 12 measurement occasions; and (2) to compare these trajectories between age groups (children 7-12 years vs adolescents 13-18 years) and between boys and girls. No experimental intervention is introduced; all participants continue to receive usual institutional care and routine school-based physical education.
Setting and Participants Participants were recruited from four state-run orphanages located in Kaifeng and Zhengzhou (Henan Province), Wuhan (Hubei Province), and Hohhot (Inner Mongolia), China. At baseline, eligible participants were 7-18 years old, had a clinical diagnosis of severe intellectual disability according to national standards, and were permanent residents of the participating orphanages. Children and adolescents with acute or unstable medical conditions that would preclude participation in basic fitness testing, or with other contraindications judged by institutional physicians, were excluded. Written informed consent was obtained from legal guardians or institutional representatives in accordance with local regulations and the ethics approval.
Assessments and Outcome Measures
Data collection started in March 2021 (T1) and continued for three years with follow-up assessments every 3 months (approximately June, September, and December each year) until March 2024, yielding 12 planned measurement time points. At each assessment, trained physical education teachers or research staff conducted standardized measurements:
Body mass index (BMI, kg/m²), calculated from height and weight.
Upper limb strength, assessed by beanbag throwing distance (meters).
Core strength, assessed by the number of correctly performed sit-ups within 1 minute.
Lower limb explosive strength, assessed by standing long jump distance (meters).
Static balance, assessed by one-leg standing time (seconds).
These measures constitute the primary and secondary outcome variables for the study. Sociodemographic characteristics (age, sex) and basic clinical information were also recorded at baseline.
Planned Data Analysis The primary analytic approach is to use generalized estimating equations (GEE) to model longitudinal changes in each fitness indicator across the 12 repeated assessments, accounting for within-subject correlation and unbalanced follow-up. Time (measurement occasion), age group at baseline (children vs adolescents), sex, and their interactions are included as predictors to estimate developmental trajectories and group differences. Analyses are conducted on the full cohort of 132 participants who contributed at least one measurement, consistent with an intention-to-follow principle for observational data.
Ethical Considerations and Status The protocol was reviewed and approved by the Ethics Committee of the Shanghai University of Physical Education and Sport (Approval No. 102772020RT054). All assessments were conducted during regular school hours using low-risk, field-based tests appropriate for children and adolescents with SID. Data collection has been completed, and this record provides a transparent description of the study procedures and analysis plan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orphanage Cohort | – | Other: Usual institutional care and school-based physical educationThis cohort includes all children and adolescents with severe intellectual disabilities who were permanent residents of the participating state-run orphanages in Kaifeng, Zhengzhou, Wuhan, and Hohhot, China. Participants were 7-18 years old at baseline and were followed prospectively for three years with repeated physical fitness assessments. No experimental intervention was introduced; all participants continued to receive usual institutional care and routine school-based physical education. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents aged 7-18 years with severe intellectual disabilities who are permanent residents of four state-run orphanages located in Kaifeng and Zhengzhou (Henan Province), Wuhan (Hubei Province), and Hohhot (Inner Mongolia), China. All eligible residents meeting the inclusion criteria were invited to participate and were followed prospectively for three years with repeated physical fitness assessments. No healthy controls were included.
Key inclusion criteria (5 listed)
- Clinical diagnosis of severe intellectual disability according to national or institutional diagnostic standards.
- Aged 7 to 18 years at baseline.
- Permanent resident of one of the participating state-run orphanages in Kaifeng, Zhengzhou, Wuhan, or Hohhot, China.
- Able, with assistance if needed, to follow simple instructions and to attempt the basic physical fitness tests used in the study (height and weight, beanbag throwing, sit-ups, standing long jump, and one-leg standing).
- Written informed consent provided by the legal guardian or institutional representative in accordance with local regulations and the ethics approval.
Key exclusion criteria (2 listed)
- Presence of an acute or unstable medical condition (e.g., severe cardiopulmonary disease, uncontrolled epilepsy, acute musculoskeletal injury) that would preclude safe participation in basic physical fitness testing.
- Any other condition or behavioural problem that, in the judgement of the institutional physician or investigators, would make participation unsafe or seriously interfere with completion of the assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual institutional care and school-based physical educationParticipants receive the usual institutional care and routine school-based physical education provided by their orphanages. The study does not introduce any experimental intervention; physical fitness is measured repeatedly over three years under real-world conditions. | Other | Orphanage Cohort |
Primary outcome
Longitudinal change in body mass index (BMI)
Time frame: From baseline (March 2021) to 36 months (March 2024), assessed at 12 time points (every 3 months).
Body mass index (BMI, kg/m²) measured at each assessment using standardized height and weight measurements. BMI values will be analyzed using generalized estimating equations (GEE) to estimate the three-year trajectory and to compare patterns of change by age group (children 7-12 years vs adolescents 13-18 years) and by sex.
Longitudinal change in upper limb strength (beanbag throwing distance)
Time frame: From baseline (March 2021) to 36 months (March 2024), assessed at 12 time points (every 3 months).
Upper limb strength assessed by beanbag throwing distance (meters) at each assessment. The best of two trials will be recorded. Generalized estimating equations (GEE) will be used to model three-year trajectories and to compare patterns of change by age group and sex.
Longitudinal change in core strength (sit-ups)
Time frame: From baseline (March 2021) to 36 months (March 2024), assessed at 12 time points (every 3 months).
Core strength assessed by the number of correctly performed sit-ups in 1 minute at each assessment. Generalized estimating equations (GEE) will be used to model three-year trajectories and to compare patterns of change by age group and sex.
Longitudinal change in lower limb explosive strength (standing long jump distance)
Time frame: From baseline (March 2021) to 36 months (March 2024), assessed at 12 time points (every 3 months).
Lower limb explosive strength assessed by standing long jump distance (meters) at each assessment. The best of two trials will be recorded. Generalized estimating equations (GEE) will be used to model three-year trajectories and to compare patterns of change by age group and sex.
Longitudinal change in static balance (one-leg standing time)
Time frame: From baseline (March 2021) to 36 months (March 2024), assessed at 12 time points (every 3 months).
Static balance assessed by one-leg standing time (seconds) at each assessment. The best performance will be recorded. Generalized estimating equations (GEE) will be used to model three-year trajectories and to compare patterns of change by age group and sex.
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 18 Dec 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Severe Intellectual Disability and Intellectual Disability, run by Xili Wen at 1 site in China.
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 5 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 18 Dec 2025. 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 China. 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?
Longitudinal change in body mass index (BMI) (time frame: From baseline (March 2021) to 36 months (March 2024), assessed at 12 time points (every 3 months).). 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?
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 18 Dec 2025.