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

Primary Purpose

Children With Down Syndrome

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aerobic exercises and Vitamin D supplementation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Children With Down Syndrome focused on measuring Aerobic exercises, Balance, Down syndrome, Physical performance, Vitamin D

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Physical Therapy - Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Physical therapy group

Physical therapy and aerobic exercises group

Physical therapy, aerobic exercises and vitamin D group

Arm Description

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

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) .

Outcomes

Primary Outcome Measures

Balance
Balance assessment will be conducted by using the Biodex Stability System (BSS; Biodex, Inc, Shirley, NY) that enables objective assessment of balance.
Physical performance
Physical performance will be evaluated using the six-minute walk test (6MWT).

Secondary Outcome Measures

Full Information

First Posted
December 17, 2018
Last Updated
November 28, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03783338
Brief Title
Interaction Effects of Vitamin D Supplementation and Aerobic Exercises on Balance and Physical Performance in Children With Down Syndrome
Official Title
Interaction Effects of Vitamin D Supplementation and Aerobic Exercises on Balance and Physical Performance in Children With Down Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 2, 2018 (Actual)
Primary Completion Date
March 2, 2019 (Actual)
Study Completion Date
March 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children With Down Syndrome
Keywords
Aerobic exercises, Balance, Down syndrome, Physical performance, Vitamin D

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
The outcomes assessor will be blinded to which each child allocated to any one of the three arms.
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical therapy group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Physical therapy and aerobic exercises group
Arm Type
Experimental
Arm Description
Group B will consist of 15 children and will receive the conventional physical therapy program and aerobic exercises.
Arm Title
Physical therapy, aerobic exercises and vitamin D group
Arm Type
Experimental
Arm Description
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) .
Intervention Type
Combination Product
Intervention Name(s)
Aerobic exercises and Vitamin D supplementation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Balance
Description
Balance assessment will be conducted by using the Biodex Stability System (BSS; Biodex, Inc, Shirley, NY) that enables objective assessment of balance.
Time Frame
This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
Title
Physical performance
Description
Physical performance will be evaluated using the six-minute walk test (6MWT).
Time Frame
This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Faculty of Physical Therapy - Cairo University
City
Cairo
State/Province
Giza
ZIP/Postal Code
12613
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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