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NCT Number: NCT04767412

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

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

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Key information

Conditions

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

Age range

10 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy

Giza, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. maximal inspiratory pressure

    Time frame: 2 months

Secondary outcomes

  1. maximal expiratory pressure

    Time frame: 2 months

  2. aerobic capacity

    Time frame: 2 months

  3. endurance

    Time frame: 2 months

    using the 6MWT

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Improvement of Physical Fitness by Inspiratory Muscle Training in Children With Down Syndrome

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Feb 23, 2021
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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