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

Full Title of Study: “Improvement of Physical Fitness by Inspiratory Muscle Training in Children With Down Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 10, 2020


  • Device: aerobic exercise training, inspiratory muscle training
    • 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.

Arms, Groups and Cohorts

  • Active Comparator: Group A
  • Active Comparator: Group B

Clinical Trial Outcome Measures

Primary Measures

  • maximal inspiratory pressure
    • Time Frame: 2 months

Secondary Measures

  • maximal expiratory pressure
    • Time Frame: 2 months
  • aerobic capacity
    • Time Frame: 2 months
  • endurance
    • Time Frame: 2 months
    • using the 6MWT

Participating in This Clinical Trial

Inclusion Criteria

  • i) children with a body mass index (BMI) ≥ 25 kg/m2, and ii) children with the ability to understand and follow verbal commands and instructions used during training and tests Exclusion Criteria:

  • Children i) with neurological, visual, or auditory defect, ii) with asthma or any chronic chest diseases, iii) with significant tightness or deformities in the lower limbs, iv) with obesity, or v) who performed regular physical activity

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: 13 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Reham Saeed Alsakhawi, Assistant Professor – Cairo University
  • Overall Official(s)
    • Reham Alsakhawi, Ph.D, Principal Investigator, Assistant Professor, Faculty of Physical Therapy, Cairo University

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