Effect of Arm Ergometry on Children With Down Syndrome

The Effects of Arm Ergometry Training on Pulmonary Function in Children With Down Syndrome

Cardiopulmonary issues are the major cause of sickness and hospitalisation in children with Down syndrome . Down syndrome children are also more likely to develop chronic lung infections, middle ear infections, and persistent tonsillitis.

Study Overview

• Status: Completed
• Conditions: EFFECT OF ARM ERGOMETRY ON RESPIRATION
• Intervention / Treatment: Other: ARMEROMTERY

Detailed Description

30 Down's syndrome children (boys and girls). randomly separated into two groups of equal size. Both groups received traditional chest physical therapy, with the addition of arm ergometry training in Group B

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Hanaa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• comprehend and follow directions
• AGE 10-14

Exclusion Criteria:

Anomalies of the vasculature.

-Participating in sports of any kind. Moderate to severe asthma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXPERMINTAL GROUP; start with cycle at a pace of 15-25 cycles per minute without resistance and end with cycle 45cycles per minute	Other: ARMEROMTERY; ARMERGOMTERY TRAINING FOR UPPERLIMB
No Intervention: CONTROL GROUP; selected respiratory exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discovery Spirometer	measure forced expiratory volume, the means incresed mean improvement	pre and post treatment for 14 weeks at 3 times per week.
Discovery spirometer	Measure peak volume,the means incresed mean improvement	Pre and post treatment for 14 weeks at 3 times per week

Collaborators and Investigators

• Sponsor: Badr University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): September 10, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: September 24, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 13, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Down Syndrome
• Other Study ID Numbers: HANAA 8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No