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

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.

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Key information

Conditions

Children With Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy - Cairo University

Cairo, Giza Governorate, 12613, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic exercises and Vitamin D supplementation

Combination 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.

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Dec 21, 2018
Registry last updated: Dec 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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