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

Cairo University (CU)

Status: Completed

Conditions: Children With Down Syndrome

Treatments: Combination Product: Aerobic exercises and Vitamin D supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT03783338

P.T.REC/012/002143

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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59 participants in 3 patient groups

Physical therapy group

Active Comparator group

Description:

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.

Treatment:

Combination Product: Aerobic exercises and Vitamin D supplementation

Physical therapy and aerobic exercises group

Experimental group

Description:

Group B will consist of 15 children and will receive the conventional physical therapy program and aerobic exercises.

Treatment:

Combination Product: Aerobic exercises and Vitamin D supplementation

Physical therapy, aerobic exercises and vitamin D group

Experimental group

Description:

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) .

Treatment:

Combination Product: Aerobic exercises and Vitamin D supplementation