Back to resultsEffect of Arm Ergometry on Children With Down Syndrome
Primary Purpose
EFFECT OF ARM ERGOMETRY ON RESPIRATION
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ARMEROMTERY
Sponsored by
About this trial
This is an interventional treatment trial for EFFECT OF ARM ERGOMETRY ON RESPIRATION
Eligibility Criteria
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
Sites / Locations
- Hanaa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
EXPERMINTAL GROUP
CONTROL GROUP
Arm Description
start with cycle at a pace of 15-25 cycles per minute without resistance and end with cycle 45cycles per minute
selected respiratory exercise program
Outcomes
Primary Outcome Measures
Discovery Spirometer
measure forced expiratory volume, the means incresed mean improvement
Discovery spirometer
Measure peak volume,the means incresed mean improvement
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05068570
Brief Title
Effect of Arm Ergometry on Children With Down Syndrome
Official Title
The Effects of Arm Ergometry Training on Pulmonary Function in Children With Down Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
September 10, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Badr University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
EFFECT OF ARM ERGOMETRY ON RESPIRATION
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EXPERMINTAL GROUP
Arm Type
Experimental
Arm Description
start with cycle at a pace of 15-25 cycles per minute without resistance and end with cycle 45cycles per minute
Arm Title
CONTROL GROUP
Arm Type
No Intervention
Arm Description
selected respiratory exercise program
Intervention Type
Other
Intervention Name(s)
ARMEROMTERY
Intervention Description
ARMERGOMTERY TRAINING FOR UPPERLIMB
Primary Outcome Measure Information:
Title
Discovery Spirometer
Description
measure forced expiratory volume, the means incresed mean improvement
Time Frame
pre and post treatment for 14 weeks at 3 times per week.
Title
Discovery spirometer
Description
Measure peak volume,the means incresed mean improvement
Time Frame
Pre and post treatment for 14 weeks at 3 times per week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hanaa
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Arm Ergometry on Children With Down Syndrome
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