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

NCT04767412 | Completed

• 1 other identifier: P.T.REC/ 012/001922
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Down Syndrome

Outcome Measures

Primary Outcomes (1)

• maximal inspiratory pressure

  2 months

Secondary Outcomes (3)

• maximal expiratory pressure

  2 months

• aerobic capacity

  2 months

• endurance

  2 months

Study Arms (2)

aerobic exercise

ACTIVE COMPARATOR

Device: aerobic exercise training, inspiratory muscle training

aerobic exercise and inspiratory muscle training

ACTIVE COMPARATOR

Device: aerobic exercise training, inspiratory muscle training

Interventions

aerobic exercise training, inspiratory muscle training DEVICE

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.

aerobic exercise; aerobic exercise and inspiratory muscle training

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, Egypt

Location

Related Publications (1)

• Elshafey MA, Alsakhawi RS. Inspiratory Muscle Training and Physical Fitness in Children With Down Syndrome: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2022 Dec;103(12):2279-2287. doi: 10.1016/j.apmr.2022.04.005. Epub 2022 May 6.

  PMID: 35533737 DERIVED

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Reham Alsakhawi, Ph.D

  Assistant Professor, Faculty of Physical Therapy, Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 23, 2021
• Study Start: September 3, 2020
• Primary Completion: December 10, 2020
• Study Completion: January 21, 2021
• Last Updated: March 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)