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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04767412
Recruitment Status : Completed
First Posted : February 23, 2021
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Reham Saeed Alsakhawi, 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


Condition or disease Intervention/treatment Phase
Down Syndrome Device: aerobic exercise training, inspiratory muscle training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improvement of Physical Fitness by Inspiratory Muscle Training in Children With Down Syndrome
Actual Study Start Date : September 3, 2020
Actual Primary Completion Date : December 10, 2020
Actual Study Completion Date : January 21, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: aerobic exercise 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.

Active Comparator: aerobic exercise and inspiratory muscle training 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.




Primary Outcome Measures :
  1. maximal inspiratory pressure [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. maximal expiratory pressure [ Time Frame: 2 months ]
  2. aerobic capacity [ Time Frame: 2 months ]
  3. endurance [ Time Frame: 2 months ]
    using the 6MWT



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04767412


Locations
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Egypt
Faculty of Physical Therapy
Giza, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Reham Alsakhawi, Ph.D Assistant Professor, Faculty of Physical Therapy, Cairo University
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Responsible Party: Reham Saeed Alsakhawi, Assistant Professor, Cairo University
ClinicalTrials.gov Identifier: NCT04767412    
Other Study ID Numbers: P.T.REC/ 012/001922
First Posted: February 23, 2021    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Down Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn