Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011336
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2001-02-15
Brief Title:
Determine the Association Between the Level of SCI With Chronic Respiratory Symptoms Measures of Pulmonary Function and Respiratory Illness
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Prospective Cohort Study of Respiratory Function and Illness in Chronic SCI
Status:
COMPLETED
Status Verified Date:
2003-02
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:
This study is using a standardized method to assess respiratory function in SCI in order to determine the association between level of SCI with chronic respiratory symptoms measures of pulmonary function and respiratory illness both cross-sectionally and longitudinally
Detailed Description:
Primary Objectives Determine the association between level of spinal cord injury SCI with chronic respiratory symptoms measures of pulmonary function and respiratory illness both cross-sectionally and longitudinally
Intervention None
Study Abstract This study is using a standardized method to assess respiratory function in SCI in order to determine the association between level of SCI with chronic respiratory symptoms measures of pulmonary function and respiratory illness both cross-sectionally and longitudinally
A community-based mail survey was made of 1147 subjects 42 response rate 2 mailings n485 Additional subjects injured 1 year ago underwent testing at the West Roxbury VAMC FVC FEV1 TLC and subdivisions maximal inspiratory and expiratory pressures MIPMEP and completed a health questionnaire based on the ATS DL-78 respiratory questionnaire Between 1094-998 a cross-sectional cohort of 361 subjects with chronic SCI were tested Multiple logistic regression was used to examine predictors of respiratory symptoms and chest illness determined from the questionnaire
From the community-based mail survey SCI with complete cervical injury CC the odds reporting any wheeze relative to lower SCI levels odds ratio 95CI was 334 175-640 p0001 and for persistent wheeze was 241 111-522 p0023 The odds of reporting chronic cough or phlegm were not increased p040 and 007 respectively Active cigarette smoking was the strongest predictor of respiratory symptoms In a subset of subjects tested at our VAMC the odds of CC SCI of reporting chest illness resulting in time off work indoors at home or in bed over 3 years before questionnaire completion relative to incomplete injury was 300 112-801 p0029 For 1 PPD current smokers the risk of chest illness was 391 171-895 p0001 for subjects who smoked post injury but quit within the previous 10 years the odds was 300 100-897 p005 For other former smokers the odds were not significantly increased Subjects who reported persistent wheeze were nearly 3 times as likely to have reported a chest illness p0036 After using a wheelchair 31 of CC subjects reported breathlessness compared to 15 with complete high thoracic and 11 of lower injuries p004 trend Subjects who were not wheelchair athletes even when lung function and SCI level were noted were twice as likely not to report breathlessness compared to athletes p0032 Subjects with SCI were able to produce reproducible spirometry Analysis of the effect of SCI level on lung function is in progress as are analyses examining predictors of chest illness in the workers tested to date
We have developed a method to assess respiratory function in SCI Using these methods complete cervical SCI have been found to experience more wheeze and breathlessness than others with SCI and are more likely to report a chest illness However active cigarette smoking was the most important predictor of chest illness and respiratory symptoms rather than injury level or completeness Therefore it is likely that SCI based smoking cessation programs would result in significantly reducing respiratory morbidity in this population The introduction of exercise programs might also result in a decreased prevalence of breathlessness in complete cervical SCI
Intervention None
Study Abstract This study is using a standardized method to assess respiratory function in SCI in order to determine the association between level of SCI with chronic respiratory symptoms measures of pulmonary function and respiratory illness both cross-sectionally and longitudinally
A community-based mail survey was made of 1147 subjects 42 response rate 2 mailings n485 Additional subjects injured 1 year ago underwent testing at the West Roxbury VAMC FVC FEV1 TLC and subdivisions maximal inspiratory and expiratory pressures MIPMEP and completed a health questionnaire based on the ATS DL-78 respiratory questionnaire Between 1094-998 a cross-sectional cohort of 361 subjects with chronic SCI were tested Multiple logistic regression was used to examine predictors of respiratory symptoms and chest illness determined from the questionnaire
From the community-based mail survey SCI with complete cervical injury CC the odds reporting any wheeze relative to lower SCI levels odds ratio 95CI was 334 175-640 p0001 and for persistent wheeze was 241 111-522 p0023 The odds of reporting chronic cough or phlegm were not increased p040 and 007 respectively Active cigarette smoking was the strongest predictor of respiratory symptoms In a subset of subjects tested at our VAMC the odds of CC SCI of reporting chest illness resulting in time off work indoors at home or in bed over 3 years before questionnaire completion relative to incomplete injury was 300 112-801 p0029 For 1 PPD current smokers the risk of chest illness was 391 171-895 p0001 for subjects who smoked post injury but quit within the previous 10 years the odds was 300 100-897 p005 For other former smokers the odds were not significantly increased Subjects who reported persistent wheeze were nearly 3 times as likely to have reported a chest illness p0036 After using a wheelchair 31 of CC subjects reported breathlessness compared to 15 with complete high thoracic and 11 of lower injuries p004 trend Subjects who were not wheelchair athletes even when lung function and SCI level were noted were twice as likely not to report breathlessness compared to athletes p0032 Subjects with SCI were able to produce reproducible spirometry Analysis of the effect of SCI level on lung function is in progress as are analyses examining predictors of chest illness in the workers tested to date
We have developed a method to assess respiratory function in SCI Using these methods complete cervical SCI have been found to experience more wheeze and breathlessness than others with SCI and are more likely to report a chest illness However active cigarette smoking was the most important predictor of chest illness and respiratory symptoms rather than injury level or completeness Therefore it is likely that SCI based smoking cessation programs would result in significantly reducing respiratory morbidity in this population The introduction of exercise programs might also result in a decreased prevalence of breathlessness in complete cervical SCI
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: