Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442715
Status:
COMPLETED
Last Update Posted:
2007-03-06
First Post:
2007-03-01
Brief Title:
Exercise Challenge Test in 3-6 Years Old Asthmatic Children
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
Exercise Challenge Test in 3-6 Years Old Asthmatic Children
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Vigorous exercise is known to cause transient bronchoconstriction in school children with asthma many of whom initially have normal lung function at rest The presence and extent of this phenomena in early childhood is difficult to recognize because exercise induced bronchoconstriction EIB may not limit the childs performance and the child may fail to notice the symptoms until taking part in organized or competitive sport Conversely as children do participate in vigorous activities all day long severe EIB may provoke a crucial disabling condition in the child
In school children the exercise challenge test ECT is a well standardized test and is used to make a diagnosis of asthma because it is able to discriminate between asthma and other chronic breathing illnesses of childhood and is also used to determine the effectiveness and optimal dosages of medications prescribed to prevent EIB
The test includes is a controlled run on a motor-driven treadmill followed by scheduled multiple spirometry maneuvers This procedure was never been tested and may not be suitable for the preschool age
In this study we assumed that a free-run test which combined with measurements of duplicate spirometry-sets would be the most convenient way to test young children
The aims of this study are a to examine the feasibility of a free-run protocol according to the ATSERS recomendations followed by duplicate spirometry measurements in early childhood
b to explore the existence of exercise induced bronchoconstriction in young children age 3-6 years old with respiratory symptoms
In school children the exercise challenge test ECT is a well standardized test and is used to make a diagnosis of asthma because it is able to discriminate between asthma and other chronic breathing illnesses of childhood and is also used to determine the effectiveness and optimal dosages of medications prescribed to prevent EIB
The test includes is a controlled run on a motor-driven treadmill followed by scheduled multiple spirometry maneuvers This procedure was never been tested and may not be suitable for the preschool age
In this study we assumed that a free-run test which combined with measurements of duplicate spirometry-sets would be the most convenient way to test young children
The aims of this study are a to examine the feasibility of a free-run protocol according to the ATSERS recomendations followed by duplicate spirometry measurements in early childhood
b to explore the existence of exercise induced bronchoconstriction in young children age 3-6 years old with respiratory symptoms
Detailed Description:
Method
The children are to come in comfortable clothes and running shoes having consumed no more than a light meal and having had pulmonary medications withdrawn as described above A parent a pediatric pulmonary physician and a technician is present throughout the test Each child undergoes a physical examination to exclude evidence of wheeze and baseline spirometry was performed The children are asked to run freely back and forth without a nose-clip in a 50m long corridor next to the pulmonary laboratory The target is to achieve 6 minutes of free run to increase hart-rate to 80 in the maximum for at least 4 minutes according to ATSERS recommendations for exercise challenge test in older children 1 An adult parenttechnician physician will run with the child to encourage himher to continue running Heart-rate and O2-saturation is monitored continuously throughout the run using a portable mobile pulse-oximeter monitor Nonin medical INC model 2500 Minneapolis USA
Spirometry is measured according to the recommendations for preschool children 2 with a commercial ZAN100 Spirometer situated in the pediatric pulmonary laboratory by a skilled technician Measurements are performed in the standing position without nose-clip for comfort of the child until two consecutive technically acceptable curves are achieved After the free-run spiroetmry is measured in duplicate sets at 1 3 5 10 and 20 minutes post-exercise 1 The better of the two curves is selected as the representative value at each interval but differences between the two values of FEV1 has to be 5 The following signs are monitored by the pulmonologist wheeze and prolonged expiration on auscultation over the trachea and two zones of both lungs upper front and lower back Cough shortness of breath or perceived breathlessness within 20 minutes after the run were noted
Analysis Technically acceptable spirometry maneuvers are analyzed Baseline values are first compared to the spirometry values with relation to height derived from the indices in 109 healthy children in our previous study 3
Following exercise best spirometry values for each interval are compared to baseline values Exercise response was defined as the greatest decrease in FEV1 expressed as a percentage of the baseline values A bronchoconstriction response to exercise is considered as positive when the FEV1 decrease from baseline was greater than 13 4 Students paired t-test is used for comparison of data between each spirometry index and the calculated values for healthy children A value of p005 was considered significant
References
1 Guidelines for Methacholine and Exercise Challenge Testing 1999 The official statements of the American Thoracic Society adopted by the ATS board of directors 1999 Am J Respir Crit Care Med 2000161309-329
2 Aurora P Stocks J Oliver C Saunders C Castle R Chaziparasidis G Bush A London Cystic Fibrosis Collaboration Quality control for spirometry in preschool children with and without lung disease Am J Respir Crit Care Med 2004 1691152-1159
3 Vilozni D Barak A Efrati O Augarten A Springer C Yahav Y Bentur L The role of computer games in measuring spirometry in healthy and asthmatic preschool children Chest 2005 1281146-115
4 Godfrey S Springer C Bar-Yishay E Avital A Cut-off points defining normal and asthmatic bronchial reactivity to exercise and inhalation challenges in children and young adults Eur Respir J 1999 14659-66
The children are to come in comfortable clothes and running shoes having consumed no more than a light meal and having had pulmonary medications withdrawn as described above A parent a pediatric pulmonary physician and a technician is present throughout the test Each child undergoes a physical examination to exclude evidence of wheeze and baseline spirometry was performed The children are asked to run freely back and forth without a nose-clip in a 50m long corridor next to the pulmonary laboratory The target is to achieve 6 minutes of free run to increase hart-rate to 80 in the maximum for at least 4 minutes according to ATSERS recommendations for exercise challenge test in older children 1 An adult parenttechnician physician will run with the child to encourage himher to continue running Heart-rate and O2-saturation is monitored continuously throughout the run using a portable mobile pulse-oximeter monitor Nonin medical INC model 2500 Minneapolis USA
Spirometry is measured according to the recommendations for preschool children 2 with a commercial ZAN100 Spirometer situated in the pediatric pulmonary laboratory by a skilled technician Measurements are performed in the standing position without nose-clip for comfort of the child until two consecutive technically acceptable curves are achieved After the free-run spiroetmry is measured in duplicate sets at 1 3 5 10 and 20 minutes post-exercise 1 The better of the two curves is selected as the representative value at each interval but differences between the two values of FEV1 has to be 5 The following signs are monitored by the pulmonologist wheeze and prolonged expiration on auscultation over the trachea and two zones of both lungs upper front and lower back Cough shortness of breath or perceived breathlessness within 20 minutes after the run were noted
Analysis Technically acceptable spirometry maneuvers are analyzed Baseline values are first compared to the spirometry values with relation to height derived from the indices in 109 healthy children in our previous study 3
Following exercise best spirometry values for each interval are compared to baseline values Exercise response was defined as the greatest decrease in FEV1 expressed as a percentage of the baseline values A bronchoconstriction response to exercise is considered as positive when the FEV1 decrease from baseline was greater than 13 4 Students paired t-test is used for comparison of data between each spirometry index and the calculated values for healthy children A value of p005 was considered significant
References
1 Guidelines for Methacholine and Exercise Challenge Testing 1999 The official statements of the American Thoracic Society adopted by the ATS board of directors 1999 Am J Respir Crit Care Med 2000161309-329
2 Aurora P Stocks J Oliver C Saunders C Castle R Chaziparasidis G Bush A London Cystic Fibrosis Collaboration Quality control for spirometry in preschool children with and without lung disease Am J Respir Crit Care Med 2004 1691152-1159
3 Vilozni D Barak A Efrati O Augarten A Springer C Yahav Y Bentur L The role of computer games in measuring spirometry in healthy and asthmatic preschool children Chest 2005 1281146-115
4 Godfrey S Springer C Bar-Yishay E Avital A Cut-off points defining normal and asthmatic bronchial reactivity to exercise and inhalation challenges in children and young adults Eur Respir J 1999 14659-66
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None