Down SyndromeNCT05271201
Exercise Intensity for Down Syndrome Children
A study testing treadmill exercise (mild) and treadmill exercise (moderate) in people with Down Syndrome, run by Taif University at 1 site in Saudi Arabia.
Trial summary
The current study aimed to determine the appropriate exercise intensity for the rehabilitation of children with down syndrome. Read more about this study
- Who is it for?
- Ages 8 to 12 years, men only
- Conditions the study is for
- Down Syndrome
- What is being tested?
- treadmill exercise (mild) and treadmill exercise (moderate)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Dec 2019to 27 Mar 2020
- 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
- Men only
- No healthy volunteers
- Child
Who may be able to join
- independent walking
- Intelligence quotient range from 40 to 70
- right dominant foot
- body mass index from 50 to 75
Who cannot join
- chronic diseases
- congenital anomalies
- involved in any competitive sport
- previous injury to the lower limb
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
College of Applied Medical Sciemces
Ta'if, Mecca Region, 2425
About this study
Official title: Effect of Exercise Intensity on Knee and Ankle Joints' Torque and Functional Mobility in Children With Down's Syndrome: a Randomized Controlled Trial
The current study aimed to determine the appropriate exercise intensity for the rehabilitation of children with down syndrome.
Read the detailed description
Two groups of down syndrome children were recruited. one group received mild-intensity treadmill training while the other received moderate-intensity treadmill training. Eccentric knee extensors and ankle plantar flexors peak torques were assessed before and after the intervention. Also, functional mobility was assessed for both groups before and after the intervention. The within and between-subjects effect was used to analyze the obtained data before and after the intervention. isokinetic dynamometer and the time up and go test were used for evaluation.
- Conditions
- Down Syndrome
- Being tested
- treadmill exercise (mild), treadmill exercise (moderate)
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treadmill exercise (mild)Other
mild intensity treadmill training.
treadmill exercise (moderate)Other
moderate-intensity treadmill training
| Study group | Role | What they receive |
|---|---|---|
| mild intensity group | Experimental | Received mild intensity treadmill training according to Martti Karvonen's formula. Receives: Other: treadmill exercise (mild) |
| moderate intensity group | Experimental | Received moderate intensity treadmill training according to Martti Karvonen's formula. Receives: Other: treadmill exercise (moderate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee extensor peak torque
eccentric normalized peak torque of the knee extensors of the dominant limb.
Measured: three months
ankle plantar fexors peak torque
eccentric normalized peak torque of the ankle plantar flexors of the dominant limb.
Measured: three months
functional mobility
the assessment of the time up and go test
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start10 Dec 2019
- Primary completion15 Mar 2020
- Study completion27 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatem Allam, Taif University
- Investigators
- Hatem H Allam, ass. prof., Principal investigator, Taif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271201
- Sponsor's protocol ID
- 291
- Status last verified
- Feb 2022
- First submitted
- 26 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Intensity on Knee and Ankle Joints' Torque and Functional Mobility in Children With Down's Syndrome: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05271201
- Acronym / sponsor ID
- 291
- Conditions
- Down Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Taif UniversityUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 27 Mar 2020 (actual)
- First posted
- 8 Mar 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.
The current study aimed to determine the appropriate exercise intensity for the rehabilitation of children with down syndrome.
Detailed description
Two groups of down syndrome children were recruited. one group received mild-intensity treadmill training while the other received moderate-intensity treadmill training. Eccentric knee extensors and ankle plantar flexors peak torques were assessed before and after the intervention. Also, functional mobility was assessed for both groups before and after the intervention. The within and between-subjects effect was used to analyze the obtained data before and after the intervention. isokinetic dynamometer and the time up and go test were used for evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mild intensity group | Experimental | Other: treadmill exercise (mild)Received mild intensity treadmill training according to Martti Karvonen's formula. |
| moderate intensity group | Experimental | Other: treadmill exercise (moderate)Received moderate intensity treadmill training according to Martti Karvonen's formula. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- independent walking
- Intelligence quotient range from 40 to 70
- right dominant foot
- body mass index from 50 to 75
Key exclusion criteria (4 listed)
- chronic diseases
- congenital anomalies
- involved in any competitive sport
- previous injury to the lower limb
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 |
|---|---|---|
| treadmill exercise (mild)mild intensity treadmill training. | Other | mild intensity group |
| treadmill exercise (moderate)moderate-intensity treadmill training | Other | moderate intensity group |
Primary outcome
knee extensor peak torque
Time frame: three months
eccentric normalized peak torque of the knee extensors of the dominant limb.
ankle plantar fexors peak torque
Time frame: three months
eccentric normalized peak torque of the ankle plantar flexors of the dominant limb.
functional mobility
Time frame: three months
the assessment of the time up and go test
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 8 Mar 2022.
Related trials for Down Syndrome
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
RecruitingObservational study
Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy
Down Syndrome
RecruitingPhase 2
Treatment of Atopic Dermatitis and Alopecia Areata With Abrocitinib in Individuals With Down Syndrome
Atopic Dermatitis, Alopecia Areata
RecruitingObservational study
The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment
Pregnant Individuals, Aneuploidy
RecruitingObservational study
Kinematic Analysis of Manual Dexterity
Down Syndrome, Hemiparesis
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.
Hatem H Allam, ass. prof. principal investigator
Taif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treadmill exercise (mild) and treadmill exercise (moderate) in people with Down Syndrome, run by Taif University at 1 site in Saudi Arabia.
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 4 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 8 Mar 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 Saudi Arabia. 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?
knee extensor peak torque (time frame: three months). The study lists 3 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 8 Mar 2022.