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

Not Applicable

Completed

• Conditions: Children With Down Syndrome
• Interventions: Combination Product: Aerobic exercises and Vitamin D supplementation

• Registration Number: NCT03783338
• Lead Sponsor: Cairo University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-02
• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2018-12-18
• Study First Posted: 2018-12-21
• Primary Completion: 2019-03-02
• Study Completion: 2019-03-02
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-28
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical therapy and aerobic exercises group	Aerobic exercises and Vitamin D supplementation	Group B will consist of 15 children and will receive the conventional physical therapy program and aerobic exercises.
Physical therapy group	Aerobic exercises and Vitamin D supplementation	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.
Physical therapy, aerobic exercises and vitamin D group	Aerobic exercises and Vitamin D supplementation	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) .

Primary Outcome Measures

Name	Time	Method
Balance	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	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).

Trial Locations

Locations (1)

Faculty of Physical Therapy - Cairo University; 🇪🇬 Cairo, Giza, Egypt