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

NCT ID: NCT04767412

Last Updated: 2021-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-03
• Study Completion Date: 2021-01-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

aerobic exercise

Group Type: ACTIVE_COMPARATOR

aerobic exercise training, inspiratory muscle training

Intervention Type: 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 and inspiratory muscle training

Group Type: ACTIVE_COMPARATOR

aerobic exercise training, inspiratory muscle training

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Reham Saeed Alsakhawi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reham Alsakhawi, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor, Faculty of Physical Therapy, Cairo University

Locations

Faculty of Physical Therapy

Giza, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 35533737 (View on PubMed)

Other Identifiers

P.T.REC/ 012/001922

Identifier Type: -

Identifier Source: org_study_id