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

• ClinicalTrials.gov Identifier: NCT04767412
• Recruitment Status: Completed
• First Posted: February 23, 2021
• Last Update Posted: March 2, 2021
• Sponsor: Cairo University
• Information provided by (Responsible Party): Reham Saeed Alsakhawi, Cairo University

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Egypt

Faculty of Physical Therapy

Giza, Egypt

Sponsors and Collaborators

Cairo University

Investigators

• Principal Investigator: Reham Alsakhawi, Ph.D; Assistant Professor, Faculty of Physical Therapy, Cairo University

More Information

• 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
• 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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Down Syndrome; Syndrome; Disease; Pathologic Processes; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn