Cognitive ImpairmentNCT05503459
Exercise and Cognition in Children With ASD
A study testing Bicycle learning and Stationary cycling in people with Cognitive Impairment and Child Autism, run by Education University of Hong Kong at 1 site in Hong Kong.
Trial summary
Physical exercise is widely reported to be beneficial to executive functions (EFs) in children with autism spectrum disorder (ASD). However, the impact of physical exercise on self-regulation (SR) in this population remains unknown. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Cognitive Impairment, Child Autism
- What is being tested?
- Bicycle learning and Stationary cycling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2021to 3 Jun 2022
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 8 - 12 years
- mild to moderate ASD (i.e., level 1-2 support classification) diagnosis from physicians or psychologists based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, (DSM-5) and Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2)
- non-verbal IQ over 50 using a brief version of the Wechsler Intelligence Scale for Children (Chinese revised) [C-WISC]
- able to follow instructions with the assistance of research staff
- able to perform the requested physical intervention, executive function measures and mediator measures with the assistance of the research staff
- no additional regular participation in physical exercise other than school physical education classes for at least one month prior to the study
- novice at riding a two-wheel bicycle (i.e., cannot ride the bicycle alone for more than 10 consecutive seconds).
Who cannot join
- other medical conditions that limited physical exercise capacities (e.g., asthma, seizure, cardiac disease)
- a complex neurologic disorder (e.g., epilepsy, phenylketonuria, fragile X syndrome, tuberous sclerosis)
- suffering from obesity (i.e., > 95 percentile of age-gender specific BMI cutoff, such that it would be difficult for research staff to catch them if they began to fall when riding
- self-reported color blindness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationships Among Executive Functions, Self-regulation and Physical Exercise in Children With Autism Spectrum Disorder
Physical exercise is widely reported to be beneficial to executive functions (EFs) in children with autism spectrum disorder (ASD). However, the impact of physical exercise on self-regulation (SR) in this population remains unknown. Moreover, very few studies have been done to examine the mechanism(s) that underlie the exercise-EF and exercise-SR relationships. The purposes of the present study were to test whether two types of physical exercise (cognitively engaging vs. non-cognitively engaging) benefited SR, and if the social, emotional and physical needs of an individual mediated the exercise-EF and exercise-SR relationships. Children diagnosed with ASD were randomly assigned into one of three groups: learning to ride a bicycle (n = 23), stationary cycling (n = 19) or an active control with walking (n = 22). Two EFs (flexibility and inhibition), SR and the mediating roles of perceived social support, enjoyment, stress, physical self-efficacy and perceived physical fitness were assessed.
Read the detailed description
Given the well-evidenced cognitive benefits of physical exercise for executive functions (EFs) in children with typical development (TD), there is growing research interest in whether such benefits could also be translated to children with autism spectrum disorder (ASD). Previously, the investigators examined the effectiveness of a 12-week basketball training intervention on inhibition control and working memory in children with ASD. Results showed that the training improved inhibition control. More recently, Liang and colleagues (2022) conducted a meta-analysis of seven studies examining the effect of physical exercise interventions on EFs in children and adolescents with ASD. They concluded that chronic exercise interventions were beneficial to overall EFs in the population, particularly for cognitive flexibility and inhibitory control. While physical exercise appears to be beneficial in this population, the mechanism by which physical exercise potentially impacts EFs in children with ASD remains a question. It is important to understand the mechanism in order to design an effective physical exercise intervention to promote the development of EFs among children with ASD.
Over the past few decades, most of the studies examining the exercise-cognition relation in the general population have viewed the mediating mechanism via a neurobiological framework, expressed most clearly by the neurotrophic hypothesis. The hypothesis states that physical activity increases metabolic demands and triggers a cascade of biochemical changes, such as enhancing cerebral blood blow and increasing the availability of brain-derived neurotrophic factor, which strengthens brain plasticity for higher-level cognitive activities such as those involved in executive functions. It is not until recently that scientists started questioning whether the exercise-cognition relation could also be mediated by a person's social, emotional, and physical needs. Diamond and Ling (2016) hypothesized that the most successful approaches for improving EFs would address social, emotional and physical needs, and that cognitively engaging physical activity (e.g., martial arts, dance) that enhances social interaction and joy would be more beneficial to EFs than less cognitively engaging physical activity. To the best of our knowledge, no previous studies have examined the possible mediating roles of social support, emotion and physical fitness in the exercise-EF relation.
Also of interest is the impact of physical exercise on self-regulation. Self-regulation (SR) is a psychological construct that encompasses a range of functional behaviors, such as interacting with peers, remembering rules and regulations, controlling emotions and inhibiting inappropriate and aggressive actions. Given these behaviors call upon the higher-order cognitive processes associated with EFs (e.g., shifting attention, working memory, inhibition), and the fact that SR and EFs predict many of the same positive outcomes (e.g., physical health, mental health, academic achievement), SR has long been thought of as the behavioral manifestation of EFs. However, several recent studies provided compelling evidence that SR and EFs are distinguishable and should be treated independently. Confusion may arise when measuring one without the other. Therefore, it is important to investigate whether physical exercise could yield similar benefits in SR as those in EFs, particularly in children with ASD where SR difficulties are common.
Therefore, the purposes of this study were to examine the exercise-SR relation, and to investigate the possible mediating roles of social and emotional experience and physical perception in the exercise-EF and exercise-SR relationships in children with ASD. In the present study, these needs were expressed by individuals' perceived social support, enjoyment, stress, physical self-efficacy and perceived physical fitness. Similar to our previous study, the investigators compared EFs among three groups: 1) learning to ride a bicycle, 2) stationary cycling and 3) active control (walking) before and immediately after the two-week intervention period. Following the suggestion by Diamond and Ling (2016), the active control group with walking (instead of a no-treatment control group) was used to control for potential Hawthorne effects. Walking was chosen because it was a low intensity physical activity that enabled us to assess the same potential mediators as those in the intervention groups. Unlike our previous study, only inhibition and flexibility were measured in this study because exercise interventions were shown effective to improve these two EFs in children with ASD, and to enhance the feasibility of the study (to avoid overburdening participants with the additional mediation assessments compared to our previous study). To examine the mediating effects, perceived social support, enjoyment, stress, physical self-efficacy, and perceived physical fitness were measured during the baseline period, mid-intervention and post-intervention.
- Conditions
- Cognitive Impairment, Child Autism
- Being tested
- Bicycle learning, Stationary cycling
- Keywords
- Cognitive function, Self-regulation, Executive Function, Physical exercise, Children, Autism
- Medical subject headings
- Cognitive Dysfunction, Autistic Disorder, Self-Control, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bicycle learningOther
The 10 intervention sessions were conducted in an identical format, comprising three activities: warm-up (10 min), bicycle learning (40 min), and cool-down (10 min). In the bicycle training activity, participants were asked to ride on a training bicycle with training wheels to gain better control of the bike in a gradual way. Participants then progressed from the training bicycle to a two-wheel bicycle. To keep participants on the learning curve, they were asked to ride through an obstacle course that was progressively more difficult to negotiate. The obstacles were designed by a focus group, which consisted of four physical education teachers from participating schools and one experienced cycling coach with more than five years of coaching experience.
Stationary cyclingOther
The 10 intervention sessions were conducted in an identical format, comprising three activities: warm-up (10 min), stationary cycling (40 min), and cool-down (10 min). For stationary cycling activity, they were also asked every 10 mins during exercise to indicate their ratings of perceived exertion (target range: 3-5). Participants were positively reinforced verbally with compliments for their efforts in the training program and their daily improvements were visualized through graphs kept in the child's home.
| Study group | Role | What they receive |
|---|---|---|
| Bicycle learning | Experimental | The protocol for this intervention group was a 2-week bicycle training program consisting of 10 sessions (five sessions per week, 60 mins per session) in a hall/gymnasium of each participating school and the Education University of Hong Kong. Each intervention session was conducted by a professional cycling instructor assisted by student helpers. The staff-to-participant ratio was 1:1. Receives: Other: Bicycle learning |
| Stationary cycling group | Experimental | Participants were asked to ride on a stationary bicycle in the same format as that in the learning to bicycle group. Receives: Other: Stationary cycling |
| Active control group | No intervention | Participants were asked to walk with their major caregivers for 20 minutes every day during the study period. After the study, they were taught how to ride a bicycle to recognize their contribution as controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of cognitive flexibility
The change of cognitive flexibility was measured by change of interference scores in the Stroop Color and Word Test between pre- and post-intervention. In the test, the participants were required to read three different tables as fast as they could. The three different tables were classified into two conditions: congruent and incongruent conditions. And the interference score was calculated based on a recognized formula ((Maximum:120; Minimum: 0). Lower interference scores indicate better cognitive flexibility.
Measured: The outcome measure was conducted day 1 before intervention and within 30 minutes after intervention.
Change of inhibition
The change of inhibition was measured by the change of false alarm scores in the Go/No-go test between pre- and post-intervention. In this assessment, participants were asked to press a left or right key as quickly as possible when the corresponding arrow appeared on the center of a computer screen (Go response), and not to press any key whenever the up arrow appeared on the screen (No-go response). The participants completed 300 trials: 220 trials requiring a Go response (110 left and 110 right) and 80 trials (26.7%) requiring a No-go response (not pressing any key). The stimuli were randomly presented, one at a time, for 500 ms followed by 1000 ms of blank interval using E-Prime 3.0 software . After blocks of 60 trials, children were offered a break of 2 minutes. A Go response in a No-go trial was coded as a false alarm. FA errors are considered an indicator of inhibition (maximum 60; minimum: 0), and the lower the error, the better the inhibition.
Measured: The outcome measure was assessed day 1 before intervention and within 30 minutes after intervention.
Perceived social support
The perceived social support of the participant was assessed with a self-reported scale referenced on the Athlete Received Support Questionnaire. Considering the comprehension difficulties of the participants, six items were chosen by the focus group (consisting of the authors, caregivers and teachers of the participants). Each participant was asked to rate their perceived social support with verbal prompting from their partnered student helpers. The total score was computed from the scale (Maximum:6; Minimum: 0). The higher the score, the better the perceived social support.
Measured: The outcome measure was conducted immediately after 5th intervention (day 5).
Enjoyment
Participants were assisted in rating their enjoyment of the interventions and walking (active control) using the Physical Activity Enjoyment Scale. The scale was rated on 5-point Likert scale). The total score was computed from the scale (Maximum: 20; Minimum: 0). The higher the total score, the better the enjoyment.
Measured: The outcome measure was conducted immediately after 5th intervention (day 5).
Stress level
Referenced on the Feeling Scale, a stress scale was designed by the focus group in the present study. Similar to the Feeling Scale, participants were asked to indicate their stress level from "very relaxed" (+5) to "very stressed" (-5) during the middle of the intervention. The higher the score, the lower the stress level.
Measured: The outcome measure was conducted immediately after 5th intervention (day 5).
Physical self-efficacy
Participants were assisted in rating their self-efficacy in the interventions and walking (active control) using the Physical Self-efficacy Scale. This scale is rated on 4-point Likert scale. The total score was computed from the scale (Maximum:16; Minimum: 0). The higher the total score, the better an individual's physical self-efficacy
Measured: The outcome measure was conducted immediately after 5th intervention (day 5).
Perceived physical fitness
Participants were asked 'How could you evaluate our own physical fitness when comparing with others?' and told to answer using a five-point scale (Maximum: 5; Minimum:0). The higher the rating, the better the perceived physical fitness.
Measured: The outcome measure was conducted immediately after 5th intervention (day 5).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Mar 2021
- Primary completion28 May 2022
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Education University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco State University, University of California, Riverside
- Responsible party
- Principal investigator, Andy Tse Choi-yeung, Education University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503459
- Sponsor's protocol ID
- EduUHK
- Status last verified
- Aug 2022
- First submitted
- 11 Aug 2022
- Last updated
- 23 Aug 2022
- 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 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationships Among Executive Functions, Self-regulation and Physical Exercise in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05503459
- Acronym / sponsor ID
- EduUHK
- Conditions
- Cognitive Impairment, Child Autism
- Keywords
- Cognitive function, Self-regulation, Executive Function, Physical exercise, Children, Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Education University of Hong KongUniversity, hospital or other
- Collaborators
- San Francisco State University, University of California, Riverside
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 28 May 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 16 Aug 2022 (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 exercise is widely reported to be beneficial to executive functions (EFs) in children with autism spectrum disorder (ASD). However, the impact of physical exercise on self-regulation (SR) in this population remains unknown. Moreover, very few studies have been done to examine the mechanism(s) that underlie the exercise-EF and exercise-SR relationships. The purposes of the present study were to test whether two types of physical exercise (cognitively engaging vs. non-cognitively engaging) benefited SR, and if the social, emotional and physical needs of an individual mediated the exercise-EF and exercise-SR relationships. Children diagnosed with ASD were randomly assigned into one of three groups: learning to ride a bicycle (n = 23), stationary cycling (n = 19) or an active control with walking (n = 22). Two EFs (flexibility and inhibition), SR and the mediating roles of perceived social support, enjoyment, stress, physical self-efficacy and perceived physical fitness were assessed.
Detailed description
Given the well-evidenced cognitive benefits of physical exercise for executive functions (EFs) in children with typical development (TD), there is growing research interest in whether such benefits could also be translated to children with autism spectrum disorder (ASD). Previously, the investigators examined the effectiveness of a 12-week basketball training intervention on inhibition control and working memory in children with ASD. Results showed that the training improved inhibition control. More recently, Liang and colleagues (2022) conducted a meta-analysis of seven studies examining the effect of physical exercise interventions on EFs in children and adolescents with ASD. They concluded that chronic exercise interventions were beneficial to overall EFs in the population, particularly for cognitive flexibility and inhibitory control. While physical exercise appears to be beneficial in this population, the mechanism by which physical exercise potentially impacts EFs in children with ASD remains a question. It is important to understand the mechanism in order to design an effective physical exercise intervention to promote the development of EFs among children with ASD.
Over the past few decades, most of the studies examining the exercise-cognition relation in the general population have viewed the mediating mechanism via a neurobiological framework, expressed most clearly by the neurotrophic hypothesis. The hypothesis states that physical activity increases metabolic demands and triggers a cascade of biochemical changes, such as enhancing cerebral blood blow and increasing the availability of brain-derived neurotrophic factor, which strengthens brain plasticity for higher-level cognitive activities such as those involved in executive functions. It is not until recently that scientists started questioning whether the exercise-cognition relation could also be mediated by a person's social, emotional, and physical needs. Diamond and Ling (2016) hypothesized that the most successful approaches for improving EFs would address social, emotional and physical needs, and that cognitively engaging physical activity (e.g., martial arts, dance) that enhances social interaction and joy would be more beneficial to EFs than less cognitively engaging physical activity. To the best of our knowledge, no previous studies have examined the possible mediating roles of social support, emotion and physical fitness in the exercise-EF relation.
Also of interest is the impact of physical exercise on self-regulation. Self-regulation (SR) is a psychological construct that encompasses a range of functional behaviors, such as interacting with peers, remembering rules and regulations, controlling emotions and inhibiting inappropriate and aggressive actions. Given these behaviors call upon the higher-order cognitive processes associated with EFs (e.g., shifting attention, working memory, inhibition), and the fact that SR and EFs predict many of the same positive outcomes (e.g., physical health, mental health, academic achievement), SR has long been thought of as the behavioral manifestation of EFs. However, several recent studies provided compelling evidence that SR and EFs are distinguishable and should be treated independently. Confusion may arise when measuring one without the other. Therefore, it is important to investigate whether physical exercise could yield similar benefits in SR as those in EFs, particularly in children with ASD where SR difficulties are common.
Therefore, the purposes of this study were to examine the exercise-SR relation, and to investigate the possible mediating roles of social and emotional experience and physical perception in the exercise-EF and exercise-SR relationships in children with ASD. In the present study, these needs were expressed by individuals' perceived social support, enjoyment, stress, physical self-efficacy and perceived physical fitness. Similar to our previous study, the investigators compared EFs among three groups: 1) learning to ride a bicycle, 2) stationary cycling and 3) active control (walking) before and immediately after the two-week intervention period. Following the suggestion by Diamond and Ling (2016), the active control group with walking (instead of a no-treatment control group) was used to control for potential Hawthorne effects. Walking was chosen because it was a low intensity physical activity that enabled us to assess the same potential mediators as those in the intervention groups. Unlike our previous study, only inhibition and flexibility were measured in this study because exercise interventions were shown effective to improve these two EFs in children with ASD, and to enhance the feasibility of the study (to avoid overburdening participants with the additional mediation assessments compared to our previous study). To examine the mediating effects, perceived social support, enjoyment, stress, physical self-efficacy, and perceived physical fitness were measured during the baseline period, mid-intervention and post-intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bicycle learning | Experimental | Other: Bicycle learningThe protocol for this intervention group was a 2-week bicycle training program consisting of 10 sessions (five sessions per week, 60 mins per session) in a hall/gymnasium of each participating school and the Education University of Hong Kong. Each intervention session was conducted by a professional cycling instructor assisted by student helpers. The staff-to-participant ratio was 1:1. |
| Stationary cycling group | Experimental | Other: Stationary cyclingParticipants were asked to ride on a stationary bicycle in the same format as that in the learning to bicycle group. |
| Active control group | No intervention | –Participants were asked to walk with their major caregivers for 20 minutes every day during the study period. After the study, they were taught how to ride a bicycle to recognize their contribution as controls. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- age 8 - 12 years
- mild to moderate ASD (i.e., level 1-2 support classification) diagnosis from physicians or psychologists based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, (DSM-5) and Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2)
- non-verbal IQ over 50 using a brief version of the Wechsler Intelligence Scale for Children (Chinese revised) [C-WISC]
- able to follow instructions with the assistance of research staff
- able to perform the requested physical intervention, executive function measures and mediator measures with the assistance of the research staff
Key exclusion criteria (4 listed)
- other medical conditions that limited physical exercise capacities (e.g., asthma, seizure, cardiac disease)
- a complex neurologic disorder (e.g., epilepsy, phenylketonuria, fragile X syndrome, tuberous sclerosis)
- suffering from obesity (i.e., > 95 percentile of age-gender specific BMI cutoff, such that it would be difficult for research staff to catch them if they began to fall when riding
- self-reported color blindness.
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 |
|---|---|---|
| Bicycle learningThe 10 intervention sessions were conducted in an identical format, comprising three activities: warm-up (10 min), bicycle learning (40 min), and cool-down (10 min). In the bicycle training activity, participants were asked to ride on a training bicycle with training wheels to gain better control of the bike in a gradual way. Participants then progressed from the training bicycle to a two-wheel bicycle. To keep participants on the learning curve, they were asked to ride through an obstacle course that was progressively more difficult to negotiate. The obstacles were designed by a focus group, which consisted of four physical education teachers from participating schools and one experienced cycling coach with more than five years of coaching experience. | Other | Bicycle learning |
| Stationary cyclingThe 10 intervention sessions were conducted in an identical format, comprising three activities: warm-up (10 min), stationary cycling (40 min), and cool-down (10 min). For stationary cycling activity, they were also asked every 10 mins during exercise to indicate their ratings of perceived exertion (target range: 3-5). Participants were positively reinforced verbally with compliments for their efforts in the training program and their daily improvements were visualized through graphs kept in the child's home. | Other | Stationary cycling group |
Primary outcome
Change of cognitive flexibility
Time frame: The outcome measure was conducted day 1 before intervention and within 30 minutes after intervention.
The change of cognitive flexibility was measured by change of interference scores in the Stroop Color and Word Test between pre- and post-intervention. In the test, the participants were required to read three different tables as fast as they could. The three different tables were classified into two conditions: congruent and incongruent conditions. And the interference score was calculated based on a recognized formula ((Maximum:120; Minimum: 0). Lower interference scores indicate better cognitive flexibility.
Change of inhibition
Time frame: The outcome measure was assessed day 1 before intervention and within 30 minutes after intervention.
The change of inhibition was measured by the change of false alarm scores in the Go/No-go test between pre- and post-intervention. In this assessment, participants were asked to press a left or right key as quickly as possible when the corresponding arrow appeared on the center of a computer screen (Go response), and not to press any key whenever the up arrow appeared on the screen (No-go response). The participants completed 300 trials: 220 trials requiring a Go response (110 left and 110 right) and 80 trials (26.7%) requiring a No-go response (not pressing any key). The stimuli were randomly presented, one at a time, for 500 ms followed by 1000 ms of blank interval using E-Prime 3.0 software . After blocks of 60 trials, children were offered a break of 2 minutes. A Go response in a No-go trial was coded as a false alarm. FA errors are considered an indicator of inhibition (maximum 60; minimum: 0), and the lower the error, the better the inhibition.
Perceived social support
Time frame: The outcome measure was conducted immediately after 5th intervention (day 5).
The perceived social support of the participant was assessed with a self-reported scale referenced on the Athlete Received Support Questionnaire. Considering the comprehension difficulties of the participants, six items were chosen by the focus group (consisting of the authors, caregivers and teachers of the participants). Each participant was asked to rate their perceived social support with verbal prompting from their partnered student helpers. The total score was computed from the scale (Maximum:6; Minimum: 0). The higher the score, the better the perceived social support.
Enjoyment
Time frame: The outcome measure was conducted immediately after 5th intervention (day 5).
Participants were assisted in rating their enjoyment of the interventions and walking (active control) using the Physical Activity Enjoyment Scale. The scale was rated on 5-point Likert scale). The total score was computed from the scale (Maximum: 20; Minimum: 0). The higher the total score, the better the enjoyment.
Stress level
Time frame: The outcome measure was conducted immediately after 5th intervention (day 5).
Referenced on the Feeling Scale, a stress scale was designed by the focus group in the present study. Similar to the Feeling Scale, participants were asked to indicate their stress level from "very relaxed" (+5) to "very stressed" (-5) during the middle of the intervention. The higher the score, the lower the stress level.
Physical self-efficacy
Time frame: The outcome measure was conducted immediately after 5th intervention (day 5).
Participants were assisted in rating their self-efficacy in the interventions and walking (active control) using the Physical Self-efficacy Scale. This scale is rated on 4-point Likert scale. The total score was computed from the scale (Maximum:16; Minimum: 0). The higher the total score, the better an individual's physical self-efficacy
Perceived physical fitness
Time frame: The outcome measure was conducted immediately after 5th intervention (day 5).
Participants were asked 'How could you evaluate our own physical fitness when comparing with others?' and told to answer using a five-point scale (Maximum: 5; Minimum:0). The higher the rating, the better the perceived physical fitness.
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 23 Aug 2022.
- 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?
A study testing Bicycle learning and Stationary cycling in people with Cognitive Impairment and Child Autism, run by Education University of Hong Kong at 1 site in Hong Kong.
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 7 inclusion and 4 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 23 Aug 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 Hong Kong. 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?
Change of cognitive flexibility (time frame: The outcome measure was conducted day 1 before intervention and within 30 minutes after intervention.). The study lists 7 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 23 Aug 2022.