Analysis of the Physical Fitness Development Trajectory of Children and Adolescents With Severe Intellectual Disabilities in Orphanages: A Three-year Longitudinal Follow-up Study

NCT07291115 | Completed

• 1 other identifier: Fitness Development Trajectory
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Severe Intellectual Disability; Intellectual Disability

Keywords

Severe intellectual disability; Physical fitness; Longitudinal study; Body mass index; Motor fitness

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  From baseline (March 2021) to 36 months (March 2024), assessed at 12 time points (every 3 months).

Study Arms (1)

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.

Other: Usual institutional care and school-based physical education

Interventions

Usual institutional care and school-based physical education OTHER

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.

Orphanage Cohort

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xili Wen: lead

Study Sites (1)

Shanghai University of Sport, School of Physical Education and Training

Shanghai, Ph.d, 200438, China

Location

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D Student

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: December 18, 2025
• Study Start: March 1, 2021
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)