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

Children With Down Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03783338
• Other study ID #: P.T.REC/012/002143
• Status: Completed
• Phase: N/A
• Start date: December 2, 2018
• Est. completion date: March 2, 2019

Study information

• Verified date: November 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 2, 2019
• Est. primary completion date: March 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Children With Down Syndrome
• Down Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy - Cairo University	Cairo	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Balance	Balance assessment will be conducted by using the Biodex Stability System (BSS; Biodex, Inc, Shirley, NY) that enables objective assessment of balance.	This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
Primary	Physical performance	Physical performance will be evaluated using the six-minute walk test (6MWT).	This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.