- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02979379
Pain in Individuals With COPD During Pulmonary Rehabilitation
Does Pulmonary Rehabilitation Aggravate or Relieve Symptoms of Pain in Individuals With COPD
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Chronic obstructive pulmonary disease (COPD) is a systemic disease associated with dyspnea, fatigue, and poor health-related quality of life. COPD is further complicated by the presence of pain which may be attributed to common comorbidities such as musculoskeletal conditions (osteoarthritis, osteoporosis), cardiac disease or diabetes. Pulmonary rehabilitation (PR) is the cornerstone of treatment for COPD however the impact of pain on PR has not been explored. It is unclear whether those experiencing chronic pain achieve a similar, lesser or greater degree of benefit compared to those without pain, or whether exercise training exacerbates symptoms. Gaining a greater understanding of the effects of an outpatient PR program on pain will provide direction into future specific treatment options which may necessary for managing chronic pain as part of PR.
Individuals with COPD who are beginning an out-patient PR program will be enrolled in the study. Those who report the presence of chronic pain will be classed as the pain group; those who report the absence of chronic pain will be classed as the comparator group. All participants will complete a 6-minute walk test and a Chronic Respiratory Disease Questionnaire (CRDQ) at the beginning of the PR program. These measures will be repeated at the end of the 8-week PR program for all participants. All participants will be asked to report their level of pain using a visual analogue scale every two weeks during the PR program.
Participants reporting chronic pain will also complete a series of questionnaires regarding their pain and coping strategies. These include; the Brief Pain Inventory (BPI), Coping Strategies Questionnaire (CSQ), Fear Avoidance Behavior Questionnaire (FABQ), Hospital Anxiety and Depression Scale (HADS) and Centre for Epidemiological Studies for Depression Survey (CES-D).
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá, M6M 2J5
- West Park Healthcare Centre
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- individuals with moderate to severe COPD based on international (GOLD) criteria
- clinically stable
- no history of acute exacerbation in the past 6 weeks
- able to provide their own informed consent
- referred to out-patient pulmonary rehabilitation at West Park Healthcare Centre
Exclusion Criteria:
- primary diagnosis other than COPD
- known cognitive impairment that would interfere with completing surveys
- cardiac, neurological or orthopedic conditions which prevent the ability to undertake exercise safely
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Control de caso
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Pain
Individuals with COPD who experience chronic pain (episodes of daily pain for a duration greater than three months)
|
|
No Pain
Individuals with COPD who do not experience pain on a regular basis.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change in qualities of pain (intensity, location, interference)
Periodo de tiempo: Change from Baseline to end of 8-Week PR program
|
Change from Baseline to end of 8-Week PR program
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change in coping ability specific to pain and fear avoidance
Periodo de tiempo: Change from Baseline to end of 8-Week PR program
|
Change from Baseline to end of 8-Week PR program
|
Relationship between depression and other psychological factors influencing chronic pain, including coping ability and fear avoidance behaviour
Periodo de tiempo: Change from Baseline to end of 8-Week PR program
|
Change from Baseline to end of 8-Week PR program
|
Change in functional exercise capacity and health related quality of life between those with chronic pain and those without pain
Periodo de tiempo: Change from Baseline to end of 8-Week PR program
|
Change from Baseline to end of 8-Week PR program
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 16-001-WP
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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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