Inspiratory Muscle Training and Physical Fitness in Children With Down Syndrome Randomized Control Trial
Primary Purpose
Down Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
aerobic exercise training, inspiratory muscle training
Sponsored by
About this trial
This is an interventional treatment trial for Down Syndrome
Eligibility Criteria
Inclusion Criteria:
- children with a body mass index (BMI) ≥ 25 kg/m2, and
- children with the ability to understand and follow verbal commands and instructions used during training and tests
Exclusion Criteria:
- with neurological, visual, or auditory defect,
- with asthma or any chronic chest diseases,
- with significant tightness or deformities in the lower limbs,
- with obesity, or
- who performed regular physical activity
Sites / Locations
- Faculty of Physical Therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
aerobic exercise
aerobic exercise and inspiratory muscle training
Arm Description
Outcomes
Primary Outcome Measures
maximal inspiratory pressure
Secondary Outcome Measures
maximal expiratory pressure
aerobic capacity
endurance
using the 6MWT
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04767412
Brief Title
Inspiratory Muscle Training and Physical Fitness in Children With Down Syndrome Randomized Control Trial
Official Title
Improvement of Physical Fitness by Inspiratory Muscle Training in Children With Down Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
December 10, 2020 (Actual)
Study Completion Date
January 21, 2021 (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
5. Study Description
Brief Summary
The purpose of this study is to investigate the effect of inspiratory muscle training on physical fitness in Down syndrome children. Twenty Down syndrome children from both genders ranged in age chronologically from seven to ten years will be selected to participate in this study. Selection of the study sample and evaluation of physical fitness improvement as well as Inspiratory Muscle training will be conducted in the Down Syndrome Charitable Association (DSCA), Riyadh City.
The study sample will be divided randomly into two equal groups of (A & B). All the children participated in the current study will receive 30 minutes of treatment session of aerobic exercise, group B will receive first 30 minutes of IMT then take a period time of rest about 30 minutes before starting the aerobic exercise. Exercise frequency three times per week for a period of three successive months.
The Body mass index (BMI) of each participated child will be determined by measuring weight/ Kg and height/ m2 using Electronic weight and height scale to include BMI ≥ 29 Kg/ m2 to exclude the obese children. Also using Six Minute Walk Test (6MWT) for measuring the aerobic capacity and Pulse Oxymeter for measuring pulse rate and Oxygen saturation. In addition, The Gio Digital pressure gauge will be used to assess Respiratory Muscle Strength of children by determining the Maximal Inspiratory (MIP) and Expiratory Pressure (MEP) which used to detect the inspiratory training intensity and reflect the improvement in respiratory muscle strength after training program. Brockport Physical Fitness Test (BPFT) will be used to measure physical fitness of the participated children. The participated children will be assessed before and after three successive months .
The obtained results of this study will measure Maximal Inspiratory (MIP) and Expiratory Pressure (MEP), Aerobic capacity, Musculoskeletal Function and Maximum Heart Rate (HR Max.) to determine the significant improvement of participated children
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aerobic exercise
Arm Type
Active Comparator
Arm Title
aerobic exercise and inspiratory muscle training
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
aerobic exercise training, inspiratory muscle training
Intervention Description
All participants received 30 min of aerobic exercise training thrice per week for a period of 12 weeks, whereas the group B received an additional 30 min of IMT before each aerobic exercise session.
Primary Outcome Measure Information:
Title
maximal inspiratory pressure
Time Frame
2 months
Secondary Outcome Measure Information:
Title
maximal expiratory pressure
Time Frame
2 months
Title
aerobic capacity
Time Frame
2 months
Title
endurance
Description
using the 6MWT
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children with a body mass index (BMI) ≥ 25 kg/m2, and
children with the ability to understand and follow verbal commands and instructions used during training and tests
Exclusion Criteria:
with neurological, visual, or auditory defect,
with asthma or any chronic chest diseases,
with significant tightness or deformities in the lower limbs,
with obesity, or
who performed regular physical activity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reham Alsakhawi, Ph.D
Organizational Affiliation
Assistant Professor, Faculty of Physical Therapy, Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Giza
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Inspiratory Muscle Training and Physical Fitness in Children With Down Syndrome Randomized Control Trial
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