Intellectual DisabilityNCT06444659
Effects of Adaptive Physical Activity on Health-related Fitness of Students With Intellectual Disabilitiesdisability
A study testing Adaptive Physical Activity Classes in people with Intellectual Disability, run by Hunan Normal University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- Adaptive Physical Activity Classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to Aug 2025
- Phase
- Interventional
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
College of Physical Education, Hunan Normal University
Changsha
Yin Guo, Doctor degree
About this study
Official title: Effects of Adaptive Physical Activity on Health-related Fitness of Students With Intellectual Disabilities
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.
- Conditions
- Intellectual Disability
- Being tested
- Adaptive Physical Activity Classes
- Keywords
- intellectual disability, health-related Fitness, Fundamental movement skills
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Physical Activity ClassesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular strength and endurance within Health-Related Physical Fitness are assessed using the handgrip strength test
Measured: up to 6 months
Body mass index (BMI) was computed based on measurements of weight and height
Measured: up to 6 months
Body fat percentage
Measured: up to 6 months
Flexibility was assessed using the Sit-and-Reach test
Measured: up to 6 months
Cardiopulmonary fitness was assessed via the 20 m PACER run
Measured: up to 6 months
FMS assessment: The Test of Gross Motor Development-2 (TGMD-2) for assessing participants' FMS development
Measured: up to 6 months
Secondary outcomes (6)
Objective measurement of participants' sleep quality using the Actigraph GT3X+
Measured: up to 6 months
Physical Activity Leves: ActiGraph GT3X+ (ActiGraph LLC, Pensacola, FL) triaxial accelerometers
Measured: up to 6 months
Quality of life : We assessed quality of life (QoL) using the World Health Organization Quality of Life (WHOQOL) scale.
Participants responded to 12 items, with each item providing five response options. The total score ranges from 12 to 60, with higher scores indicating better quality of life.
Measured: up to 6 months
The Physical Activity Enjoyment Scale (PACES): It is used to assess enjoyment of physical activity.
The questionnaire consists of 16 questions rated on a 5-point scale. The scale consists of 9 positively worded items and 7 negatively worded items. Scores for the 7 negatively worded items are reverse-coded and then combined with the scores for the positively worded items. Higher total scores indicate greater levels of enjoyment.
Measured: up to 6 months
Childhood Autism Rating Scale (CARS): It is used to assess the severity of autism symptoms.
The CARS consists of 15 items, each addressing different aspects of autism. Each item is rated on a scale from 1 to 4, where 1 indicates "behavior comparable to age expectations," 2 denotes "slightly atypical," 3 reflects "moderately atypical," and 4 signifies "severely atypical." The total score ranges from 15 to 60, with higher scores indicating more severe autism symptoms. Scores between 30 and 37 indicate mild to moderate autism, while scores above 37 represent severe autism.
Measured: up to 6 months
Sleep Disturbance Scale for Children (SDSC): It is used to evaluate the severity of sleep disturbances.
It includes 26 items rated on a 5-point Likert scale from "never" to "always," with scores ranging from 1 to 5. A total score above 39, based on Bruni et al.'s study, indicates sleep disturbances, with a sensitivity of 0.89 and specificity of 0.74.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 Aug 2024
- Primary completionJun 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peiying Huang, Hunan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444659
- Sponsor's protocol ID
- HunanNU
- Status last verified
- Sep 2024
- First submitted
- 24 May 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39525834
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adaptive Physical Activity on Health-related Fitness of Students With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT06444659
- Acronym / sponsor ID
- HunanNU
- Conditions
- Intellectual Disability
- Keywords
- intellectual disability, health-related Fitness, Fundamental movement skills
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hunan Normal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 5 Jun 2024 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptive physical activities | Experimental | Behavioral: Adaptive Physical Activity Classes1. 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 |
| 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Adaptive Physical Activity ClassesThe 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. | Behavioural | Adaptive physical activities |
Primary outcome
Muscular strength and endurance within Health-Related Physical Fitness are assessed using the handgrip strength test
Time frame: up to 6 months
Body mass index (BMI) was computed based on measurements of weight and height
Time frame: up to 6 months
Body fat percentage
Time frame: up to 6 months
Flexibility was assessed using the Sit-and-Reach test
Time frame: up to 6 months
Cardiopulmonary fitness was assessed via the 20 m PACER run
Time frame: up to 6 months
FMS assessment: The Test of Gross Motor Development-2 (TGMD-2) for assessing participants' FMS development
Time frame: up to 6 months
6 secondary outcomes
Objective measurement of participants' sleep quality using the Actigraph GT3X+
Time frame: up to 6 months
Physical Activity Leves: ActiGraph GT3X+ (ActiGraph LLC, Pensacola, FL) triaxial accelerometers
Time frame: up to 6 months
Quality of life : We assessed quality of life (QoL) using the World Health Organization Quality of Life (WHOQOL) scale.
Time frame: up to 6 months
The Physical Activity Enjoyment Scale (PACES): It is used to assess enjoyment of physical activity.
Time frame: up to 6 months
Childhood Autism Rating Scale (CARS): It is used to assess the severity of autism symptoms.
Time frame: up to 6 months
Sleep Disturbance Scale for Children (SDSC): It is used to evaluate the severity of sleep disturbances.
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 39525834Shen 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Physical Activity Classes in people with Intellectual Disability, run by Hunan Normal University 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 3 inclusion and 3 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 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peiying Huang (19873081845, 202220152990@hunnu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscular strength and endurance within Health-Related Physical Fitness are assessed using the handgrip strength test (time frame: up to 6 months). The study lists 6 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 NCT06444659, which also lists 1 linked publication.
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 19 Sep 2024.