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

NCT03783338 | Completed

• 1 other identifier: P.T.REC/012/002143
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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

Keywords

Aerobic exercises; Balance; Down syndrome; Physical performance; Vitamin D

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (3)

Physical therapy group

ACTIVE COMPARATOR

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.

Combination Product: Aerobic exercises and Vitamin D supplementation

Physical therapy and aerobic exercises group

EXPERIMENTAL

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

Combination Product: Aerobic exercises and Vitamin D supplementation

Physical therapy, aerobic exercises and vitamin D group

EXPERIMENTAL

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) .

Combination Product: Aerobic exercises and Vitamin D supplementation

Interventions

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.

Physical therapy and aerobic exercises group; Physical therapy group; Physical therapy, aerobic exercises and vitamin D group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Medical conditions that will severely limit a child's participation in the study as cardiac problems.
• Musculoskeletal deformities of the lower limbs.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy - Cairo University

Cairo, Giza Governorate, 12613, Egypt

Location

MeSH Terms

Conditions

Down Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded to which each child allocated to any one of the three arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Children will be assigned randomly using sealed envelopes into three intervention groups (A, B and C groups). Group A will receive the conventional physical therapy program (CPTP) only. Group B will receive the CPTP in addition to aerobic exercises, whereas group C will receive CPTP, aerobic exercises in addition to an oral daily dose of vitamin D3 1000 IU (Cholecalciferol). All groups will receive the treatment program for 12 weeks.

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 21, 2018
• Study Start: December 2, 2018
• Primary Completion: March 2, 2019
• Study Completion: March 2, 2019
• Last Updated: December 2, 2019

Record last verified: 2019-11

Locations

EG (1)