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Determine the Association Between the Level of SCI With Chronic Respiratory Symptoms, Measures of Pulmonary Function, and Respiratory Illness.

20 de enero de 2009 actualizado por: US Department of Veterans Affairs

Prospective Cohort Study of Respiratory Function and Illness in Chronic SCI

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.

Descripción general del estudio

Estado

Terminado

Descripción detallada

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, n=485). Additional subjects injured >1 year ago underwent testing at the West Roxbury VAMC (FVC, FEV1, TLC and subdivisions, maximal inspiratory and expiratory pressures (MIP/MEP), and completed a health questionnaire based on the ATS DL-78 respiratory questionnaire. Between 10/94-9/98, 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 (95%CI)) was 3.34 (1.75-6.40), p<0.001, and for ?persistent wheeze? was 2.41 (1.11-5.22), p=0.023. The odds of reporting chronic cough or phlegm were not increased (p=0.40 and 0.07 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 3.00 (1.12-8.01), p=0.029. For 1 PPD current smokers the risk of chest illness was 3.91 (1.71-8.95), p=0.001, for subjects who smoked post injury but quit within the previous 10 years the odds was 3.00 (1.00-8.97), p=0.05. 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 (p=0.036). After using a wheelchair, 31% of CC subjects reported breathlessness, compared to 15% with complete high thoracic, and 11% of lower injuries (p=0.04 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 (p=0.032). 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.

Tipo de estudio

De observación

Inscripción

400

Contactos y Ubicaciones

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Ubicaciones de estudio

    • Massachusetts
      • West Roxbury, Massachusetts, Estados Unidos, 02132
        • Boston VA Health Care System

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Spinal cord injury of >= 1 year in duration, and no other neuromuscular diseases

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Director de estudio: Robert Brown, MD
  • Director de estudio: Carlos Tur, MD

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 1998

Finalización del estudio

1 de junio de 2002

Fechas de registro del estudio

Enviado por primera vez

15 de febrero de 2001

Primero enviado que cumplió con los criterios de control de calidad

16 de febrero de 2001

Publicado por primera vez (Estimar)

19 de febrero de 2001

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

21 de enero de 2009

Última actualización enviada que cumplió con los criterios de control de calidad

20 de enero de 2009

Última verificación

1 de febrero de 2003

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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