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Interaction Effects of Vitamin D Supplementation and Aerobic Exercises on Cognition, Balance and Physical Performance in Children With Down Syndrome

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ClinicalTrials.gov Identifier: NCT03783338
Recruitment Status : Recruiting
First Posted : December 21, 2018
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Ahmed Mahmoud Eid, Cairo University

Brief Summary:

Objective: To investigate the interaction effects of vitamin D supplementation and aerobic exercises on cognition, 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 cognition by using the pediatric quality of life (PedsQL)TM cognitive module - version 3.0 - parent version, 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.


Condition or disease Intervention/treatment Phase
Children With Down Syndrome Combination Product: Aerobic exercises and Vitamin D supplementation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description: The outcomes assessor will be blinded to which each child allocated to any one of the three arms.
Primary Purpose: Treatment
Official Title: Interaction Effects of Vitamin D Supplementation and Aerobic Exercises on Cognition, Balance and Physical Performance in Children With Down Syndrome
Actual Study Start Date : December 2, 2018
Estimated Primary Completion Date : March 2, 2019
Estimated Study Completion Date : March 2, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: Physical therapy group
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.
Combination Product: Aerobic exercises and Vitamin D supplementation

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.


Experimental: Physical therapy and aerobic exercises group
Group B will consist of 15 children and will receive the conventional physical therapy program and aerobic exercises.
Combination Product: Aerobic exercises and Vitamin D supplementation

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.


Experimental: Physical therapy, aerobic exercises and vitamin D group
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) .
Combination Product: Aerobic exercises and Vitamin D supplementation

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.





Primary Outcome Measures :
  1. Cognition [ 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. ]

    Cognition will be evaluated by using the pediatric quality of life cognitive module - version 3.0 - parent version. The questionnaire consists of 6 items that measure all cognitive functions which include; Difficulty keeping his/her attention on things, difficulty remembering what people tell him/her, difficulty remembering what he/she just heard, difficulty thinking quickly, trouble remembering what he/she was just thinking and trouble remembering more than one thing at a time.

    The responses are classified on a five-point rating scale which consists of 0 (never a problem), 1 (almost never a problem), 2 (sometimes a problem), 3 (often a problem), and 4 (almost always a problem). These responses will be reversed and transformed to a 0-100 scale as follows; 0=100, 1=75, 2= 50, 3=25 and 4=0 yielding a total score by summation of all answered items. The higher score indicating a higher level of cognitive function.


  2. 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.

  3. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Medical conditions that will severely limit a child's participation in the study as cardiac problems.
  • Musculoskeletal deformities of the lower limbs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783338


Contacts
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Contact: Mohamed Ahmed Eid, Assit. Prof 00966597620659 mohamed.eid27@yahoo.com
Contact: Sobhy Mahmoud Aly, Assist. Prof 00966568582276 drsobhymahmoud@gmail.com

Locations
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Egypt
Faculty of Physical Therapy - Cairo University Recruiting
Cairo, Giza, Egypt, 12613
Contact: Amira El-Tohamy, Prof         
Sponsors and Collaborators
Cairo University

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Responsible Party: Mohamed Ahmed Mahmoud Eid, Assistant Professor, Cairo University
ClinicalTrials.gov Identifier: NCT03783338     History of Changes
Other Study ID Numbers: P.T.REC/012/002143
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mohamed Ahmed Mahmoud Eid, Cairo University:
Aerobic exercises
Balance
Cognition
Down syndrome
Physical performance
Vitamin D

Additional relevant MeSH terms:
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Syndrome
Down Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents