Effect of Arm Ergometry on Children With Down Syndrome

• Sponsor: Badr University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05068570
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 4
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
EFFECT OF ARM ERGOMETRY ON RESPIRATION	Other: ARMEROMTERY	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Effects of Arm Ergometry Training on Pulmonary Function in Children With Down Syndrome
• Actual Study Start Date: Jun 1, 2021
• Actual Primary Completion Date: Sep 10, 2021
• Actual Study Completion Date: Sep 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Discovery Spirometer [pre and post treatment for 14 weeks at 3 times per week.]

   measure forced expiratory volume, the means incresed mean improvement

2. Discovery spirometer [Pre and post treatment for 14 weeks at 3 times per week]

   Measure peak volume,the means incresed mean improvement

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hanaa	Cairo		Egypt

Sponsors and Collaborators

• Badr University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: hanaa mohsen, lecturer in the deparment of pediatrics and peditaric surgery , faculty of phyical therapy, Badr University
• ClinicalTrials.gov Identifier: NCT05068570
• Other Study ID Numbers: HANAA 8
• First Posted: Oct 6, 2021
• Last Update Posted: Feb 15, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Down Syndrome

Study Results

No Results Posted as of Feb 15, 2022