Inspiratory Muscle Training and Physical Fitness in Children With Down Syndrome Randomized Control Trial

Not Applicable

Completed

• Conditions: Down Syndrome
• Interventions: Device: aerobic exercise training, inspiratory muscle training

• Registration Number: NCT04767412
• Lead Sponsor: Cairo University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-03
• Primary Completion: 2020-12-10
• Study Completion: 2021-01-21
• Status Verified: 2021-02
• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-23
• Last Update Submitted: 2021-02-26
• Last Update Posted: 2021-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aerobic exercise	aerobic exercise training, inspiratory muscle training	-
aerobic exercise and inspiratory muscle training	aerobic exercise training, inspiratory muscle training	-

Primary Outcome Measures

Name	Time	Method
maximal inspiratory pressure	2 months

Secondary Outcome Measures

Name	Time	Method
maximal expiratory pressure	2 months
aerobic capacity	2 months
endurance	2 months	using the 6MWT

Trial Locations

Locations (1)

Faculty of Physical Therapy; 🇪🇬 Giza, Egypt