Children With Down SyndromeNCT03783338
Interaction Effects of Vitamin D Supplementation and Aerobic Exercises on Balance and Physical Performance in Children With Down Syndrome
A study testing Aerobic exercises and Vitamin D supplementation in people with Children With Down Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
Objective: To investigate the interaction effects of vitamin D supplementation and aerobic exercises on balance control and physical performance in children with Down syndrome (DS). Methods: Forty-five children with DS ranging in age from 8 to 12 years will be selected and will participate in this study. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Children With Down Syndrome
- What is being tested?
- Aerobic exercises and Vitamin D supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Dec 2018to 2 Mar 2019
- 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
- Children with DS who can stand and walk independently
- Children with 25 (OH) vitamin D levels of 16 ng/ml or less
- Children who are not consuming estrogens, steroids or other medications that could interfere with vitamin D metabolism
- The absence of visual and hearing impairments that could interfere with testing and training protocols
- Children with mild intellectual disabilities and were capable of understanding visual and verbal instructions.
Who cannot join
- Medical conditions that will severely limit a child's participation in the study as cardiac problems.
- Musculoskeletal deformities of the lower limbs.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy - Cairo University
Cairo, Giza Governorate, 12613
About this study
Objective: To investigate the interaction effects of vitamin D supplementation and aerobic exercises on balance control and physical performance in children with Down syndrome (DS).
Methods: Forty-five children with DS ranging in age from 8 to 12 years will be selected and will participate in this study. They will be assigned randomly using sealed envelopes into three equal groups (A, B and C). Group A will consist of 15 children and will receive the conventional physical therapy program (CPTP) only. Group B will consist of 15 children and will receive the CPTP plus the aerobic exercises. Group C also will consist of 15 children and will receive the CPTP, the aerobic exercises and Vitamin D supplementation in the form of an oral dose of vitamin D3 1000 IU (Cholecalciferol). The program of treatment will be 3 days/week for 12 weeks. Evaluation of balance by using the biodex balance system and physical performance by using the six-minute walk test (6MWT) will be conducted at baseline and after 12 weeks of the treatment program.
- Conditions
- Children With Down Syndrome
- Being tested
- Aerobic exercises and Vitamin D supplementation
- Keywords
- Aerobic exercises, Balance, Down syndrome, Physical performance, Vitamin D
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercises and Vitamin D supplementationCombination product
Aerobic exercises:
Children in groups B and C will receive aerobic exercises in the form of bicycle ergometer and treadmill training for 15 min 3 days/week for 12 weeks. The procedure and goals of exercise will be explained to all children before starting the exercise program. The child will stop exercising immediately if he feels pain, fainting or shortness of breath.
Vitamin D supplementation:
Children in group C only will receive vitamin D supplementation in the form of an oral daily dose of vitamin D3 1000 IU (Cholecalciferol) for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Physical therapy group | Active comparator | Group A will consist of 15 children and will receive the conventional physical therapy program only. This group will be used to compare the results of the other two groups. Receives: Combination Product: Aerobic exercises and Vitamin D supplementation |
| Physical therapy and aerobic exercises group | Experimental | Group B will consist of 15 children and will receive the conventional physical therapy program and aerobic exercises. Receives: Combination Product: Aerobic exercises and Vitamin D supplementation |
| Physical therapy, aerobic exercises and vitamin D group | Experimental | Group C will consist of 15 children and will receive the conventional physical therapy program, aerobic exercises and an oral daily dose of vitamin D3 1000 IU (Cholecalciferol) . Receives: Combination Product: Aerobic exercises and Vitamin D supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Balance assessment will be conducted by using the Biodex Stability System (BSS; Biodex, Inc, Shirley, NY) that enables objective assessment of balance.
Measured: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
Physical performance
Physical performance will be evaluated using the six-minute walk test (6MWT).
Measured: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start2 Dec 2018
- Primary completion2 Mar 2019
- Study completion2 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Down SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- Children will be assigned randomly using sealed envelopes into three intervention groups (A, B and C groups). Group A will receive the conventional physical therapy program (CPTP) only. Group B will receive the CPTP in addition to aerobic exercises, whereas group C will receive CPTP, aerobic exercises in addition to an oral daily dose of vitamin D3 1000 IU (Cholecalciferol). All groups will receive the treatment program for 12 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Mahmoud Eid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783338
- Sponsor's protocol ID
- P.T.REC/012/002143
- Status last verified
- Nov 2019
- First submitted
- 17 Dec 2018
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction Effects of Vitamin D Supplementation and Aerobic Exercises on Balance and Physical Performance in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT03783338
- Acronym / sponsor ID
- P.T.REC/012/002143
- Conditions
- Children With Down Syndrome
- Keywords
- Aerobic exercises, Balance, Down syndrome, Physical performance, Vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Dec 2018 (actual)
- Primary completion
- 2 Mar 2019 (actual)
- Study completion
- 2 Mar 2019 (actual)
- First posted
- 21 Dec 2018 (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.
Objective: To investigate the interaction effects of vitamin D supplementation and aerobic exercises on balance control and physical performance in children with Down syndrome (DS).
Methods: Forty-five children with DS ranging in age from 8 to 12 years will be selected and will participate in this study. They will be assigned randomly using sealed envelopes into three equal groups (A, B and C). Group A will consist of 15 children and will receive the conventional physical therapy program (CPTP) only. Group B will consist of 15 children and will receive the CPTP plus the aerobic exercises. Group C also will consist of 15 children and will receive the CPTP, the aerobic exercises and Vitamin D supplementation in the form of an oral dose of vitamin D3 1000 IU (Cholecalciferol). The program of treatment will be 3 days/week for 12 weeks. Evaluation of balance by using the biodex balance system and physical performance by using the six-minute walk test (6MWT) will be conducted at baseline and after 12 weeks of the treatment program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Children will be assigned randomly using sealed envelopes into three intervention groups (A, B and C groups). Group A will receive the conventional physical therapy program (CPTP) only. Group B will receive the CPTP in addition to aerobic exercises, whereas group C will receive CPTP, aerobic exercises in addition to an oral daily dose of vitamin D3 1000 IU (Cholecalciferol). All groups will receive the treatment program for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Physical therapy group | Active comparator | Combination Product: Aerobic exercises and Vitamin D supplementationGroup A will consist of 15 children and will receive the conventional physical therapy program only. This group will be used to compare the results of the other two groups. |
| Physical therapy and aerobic exercises group | Experimental | Combination Product: Aerobic exercises and Vitamin D supplementationGroup B will consist of 15 children and will receive the conventional physical therapy program and aerobic exercises. |
| Physical therapy, aerobic exercises and vitamin D group | Experimental | Combination Product: Aerobic exercises and Vitamin D supplementationGroup C will consist of 15 children and will receive the conventional physical therapy program, aerobic exercises and an oral daily dose of vitamin D3 1000 IU (Cholecalciferol) . |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children with DS who can stand and walk independently
- Children with 25 (OH) vitamin D levels of 16 ng/ml or less
- Children who are not consuming estrogens, steroids or other medications that could interfere with vitamin D metabolism
- The absence of visual and hearing impairments that could interfere with testing and training protocols
- Children with mild intellectual disabilities and were capable of understanding visual and verbal instructions.
Key exclusion criteria (2 listed)
- Medical conditions that will severely limit a child's participation in the study as cardiac problems.
- Musculoskeletal deformities of the lower limbs.
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 |
|---|---|---|
| Aerobic exercises and Vitamin D supplementationAerobic exercises: Children in groups B and C will receive aerobic exercises in the form of bicycle ergometer and treadmill training for 15 min 3 days/week for 12 weeks. The procedure and goals of exercise will be explained to all children before starting the exercise program. The child will stop exercising immediately if he feels pain, fainting or shortness of breath. Vitamin D supplementation: Children in group C only will receive vitamin D supplementation in the form of an oral daily dose of vitamin D3 1000 IU (Cholecalciferol) for 12 weeks. | Combination product | Physical therapy and aerobic exercises group, Physical therapy group, Physical therapy, aerobic exercises and vitamin D group |
Primary outcome
Balance
Time frame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
Balance assessment will be conducted by using the Biodex Stability System (BSS; Biodex, Inc, Shirley, NY) that enables objective assessment of balance.
Physical performance
Time frame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
Physical performance will be evaluated using the six-minute walk test (6MWT).
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 2 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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 Aerobic exercises and Vitamin D supplementation in people with Children With Down Syndrome, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 2 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 2 Dec 2019. 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 Egypt. 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?
Balance (time frame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.). The study lists 2 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 2 Dec 2019.