NCT06444659

Brief Summary

The object of this study is the theory and practice of adaptive physical activity for people with intellectual disability. It focuses on the concepts, paths, and applications of adaptive physical activities for young people with intellectual disability, and systematically studies and discusses the concepts, paths, and application strategies of adaptive physical activities for young people with intellectual disability, so as to provide solutions and support for the scientific exercise of this special population group. The study will focus on the following four aspects: (1) theoretical research on the interventions of young people with intellectual disability (2) analysis of the sports and health needs of young people with intellectual disability (3) empirical research on adaptive physical activities for young people with intellectual disability (4) exploration of strategies for the use of adaptive physical activities. Based on theoretical and practical research, to understand the current situation of sports participation and influencing factors of Effects of adaptive physical activity on health-related Fitness and Fundamental Movement Skills in students with intellectual disability , to provide a reliable basis for the formulation of adaptive sports activity programmes suitable for the rehabilitation concepts of the Effects of adaptive physical activity on health-related Fitness and Fundamental Movement Skills in students with intellectual disability; to increase the interest of Effects of adaptive physical activity on health-related Fitness and Fundamental Movement Skills in students with intellectual disability in sports activities, so as to enable them to master the basic sports skills, have the physical abilities required for completing the basic social activities, and be able to participate in sports activities on a regular basis in their future lives; and to promote their physical health and happy lives, with a view to facilitating their integration into regular education and, ultimately, social integration.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

May 24, 2024

Last Update Submit

September 9, 2024

Conditions

Keywords

intellectual disabilityhealth-related FitnessFundamental movement skills

Outcome Measures

Primary Outcomes (6)

  • Muscular strength and endurance within Health-Related Physical Fitness are assessed using the handgrip strength test

    up to 6 months

  • Body mass index (BMI) was computed based on measurements of weight and height

    up to 6 months

  • Body fat percentage

    up to 6 months

  • Flexibility was assessed using the Sit-and-Reach test

    up to 6 months

  • Cardiopulmonary fitness was assessed via the 20 m PACER run

    up to 6 months

  • FMS assessment: The Test of Gross Motor Development-2 (TGMD-2) for assessing participants' FMS development

    up to 6 months

Secondary Outcomes (6)

  • Objective measurement of participants' sleep quality using the Actigraph GT3X+

    up to 6 months

  • Physical Activity Leves: ActiGraph GT3X+ (ActiGraph LLC, Pensacola, FL) triaxial accelerometers

    up to 6 months

  • Quality of life : We assessed quality of life (QoL) using the World Health Organization Quality of Life (WHOQOL) scale.

    up to 6 months

  • The Physical Activity Enjoyment Scale (PACES): It is used to assess enjoyment of physical activity.

    up to 6 months

  • Childhood Autism Rating Scale (CARS): It is used to assess the severity of autism symptoms.

    up to 6 months

  • +1 more secondary outcomes

Study Arms (2)

Adaptive physical activities

EXPERIMENTAL

1. Intervention time: 6 months 2. Exercise frequency: 3 times/week 3. Exercise type: aerobic exercise 4. Exercise intensity: 40-80% HRmax 5. Collaborating with families to create a parent-supported exercise environment

Behavioral: Adaptive Physical Activity Classes

Traditional physical education

NO INTERVENTION

Continue to carry out the original regular physical education activities during the same period of time, and maintain the original daily habits.

Interventions

The intervention group received a 6 months adaptive physical activity intervention; the control group, on the other hand, continued their original regular physical activity programme for the same period of time and maintained their original lifestyle habits.

Adaptive physical activities

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Clinical diagnosis of Intellectual disability
  • Agree and promise to participate in the exercise intervention throughout the study programme
  • No other physical activity other than participation in school sports

You may not qualify if:

  • Have other medical conditions that limit physical activity (e.g. asthma, heart disease, etc.)
  • Suffers from complex neurological disorders
  • unable to play sports due to abnormal physical development

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Physical Education, Hunan Normal University

Changsha, China

RECRUITING

Related Publications (1)

  • Shen X, Huang P, Liu Q, Guo Y, Zheng L. Telehealth based parental support over 6 months improves physical activity and sleep quality in children with autism: a randomized controlled trial. Front Pediatr. 2024 Oct 25;12:1496827. doi: 10.3389/fped.2024.1496827. eCollection 2024.

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 24, 2024

First Posted

June 5, 2024

Study Start

August 1, 2024

Primary Completion

June 1, 2025

Study Completion

August 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations