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

NCT ID: NCT03783338

Last Updated: 2019-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-02
• Study Completion Date: 2019-03-02

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.

Conditions

Children With Down Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Aerobic exercises and Vitamin D supplementation

Intervention Type: 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.

Physical therapy and aerobic exercises group

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

Group Type: EXPERIMENTAL

Aerobic exercises and Vitamin D supplementation

Intervention Type: 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.

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) .

Group Type: EXPERIMENTAL

Aerobic exercises and Vitamin D supplementation

Intervention Type: 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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility 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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ahmed Mahmoud Eid

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Physical Therapy - Cairo University

Cairo, Giza Governorate, Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/002143

Identifier Type: -

Identifier Source: org_study_id