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

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.

Study Overview

• Status: Completed
• Conditions: Children With Down Syndrome
• Intervention / Treatment: Combination product: Aerobic exercises and Vitamin D supplementation

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 12613
      • Faculty of physical therapy - Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	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.
EXPERIMENTAL: Physical therapy and aerobic exercises group; 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; 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.
EXPERIMENTAL: 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) .	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 2, 2018
• Primary Completion (ACTUAL): March 2, 2019
• Study Completion (ACTUAL): March 2, 2019

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (ACTUAL): December 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 28, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Balance; Vitamin D; Down syndrome; Physical performance; Aerobic exercises
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Down Syndrome; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: P.T.REC/012/002143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No