Clinical trial NCT03783338: 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
Overall status: COMPLETED
Phase: NA
Conditions: Children With Down Syndrome
Keywords: Aerobic exercises
Balance
Down syndrome
Physical performance
Vitamin D
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-12-21
Enrollment: 59
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Balance
timeFrame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
measure: Physical performance
timeFrame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy - Cairo University
state: Giza
Study officials:
References: