Does Pulmonary Rehabilitation Improve Balance in People With Respiratory Disease?
26 de agosto de 2014 actualizado por: Ms. Elizabeth Harvey, University of Manitoba
Does a Pulmonary Rehabilitation Program Improve Balance in Individuals With Respiratory Disease?
The purpose of this study is to determine whether participation in pulmonary rehabilitation improves balance in people with respiratory disease.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Falls and chronic respiratory are two major health concerns affecting morbidity and mortality in older adults.
Several factors that predispose falls, such as reduced balance, have been documented in people with respiratory disease.
Pulmonary rehabilitation programs, which involve customized exercise prescription, are recommended to improve quality of life and disease management in people with chronic obstructive pulmonary disease (COPD).
There are many documented benefits to participation in such programs; however, the impact on balance and other falls risk factors has not previously been investigated.
Therefore, the aim of this study is to investigate the effect of a pulmonary rehabilitation program on balance and falls risk factors in individuals with respiratory disease.
This study will enhance the current management of respiratory disease by improving our understanding of the effects of pulmonary rehabilitation.
Tipo de estudio
Intervencionista
Inscripción (Actual)
14
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Manitoba
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Winnipeg, Manitoba, Canadá, R3E 0T6
- The University of Manitoba
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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
Inclusion Criteria:
- Clinical diagnosis of lung disease
- Committed to regular attendance at pulmonary rehabilitation program
- A forced expiratory volume in 1 second (FEV1) < 80% of predicted
- No change in medications for the past 2 months
Exclusion Criteria:
- Unstable cardiac disease
- Neurological conditions
- Musculoskeletal conditions that prevent participation in exercise sessions.
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?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Pulmonary rehabilitation
People with respiratory disease
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Pulmonary rehabilitation involves the prescription of customized exercise programs and education on disease management.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Standing Balance - Sway Path
Periodo de tiempo: Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
|
Standing balance was measured using a force plate (AMTI, Watertown, MA, USA) from which centre of pressure (COP) trajectories were derived at a sampling frequency of 100Hz.
Participants stood on the force plate during the following two conditions: normal stance (feet hip-width apart) with eyes open and eyes closed.
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Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
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Dynamic Balance
Periodo de tiempo: Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
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Dynamic balance was measured using the timed up and go (TUG) and Four Square Step Test (FSST).
For the TUG, the time taken for the subject to stand from a chair, walk 3 m, turn around and return to the chair was recorded {Podsiadlo, 1991 #31}.
Subjects were asked to do this as quickly and safely as possible.
High test-retest reliability of the TUG has been reported in older community-dwelling individuals {Steffen, 2002 #34}.
In the FSST, subjects were asked to step to four corners of a square in a clockwise and then counter-clockwise direction as quickly as possible {Dite, 2002 #1181}.
The time taken to complete this circuit was recorded.
This test has been shown to have high inter-rater and test-retest reliability {Dite, 2002 #1181}.
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Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
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Standing Balance - Critical Point in Time
Periodo de tiempo: Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
|
Standing balance was measured using a force plate (AMTI, Watertown, MA, USA) from which centre of pressure (COP) trajectories were derived at a sampling frequency of 100Hz.
Participants stood on the force plate during the following two conditions: normal stance (feet hip-width apart) with eyes open and eyes closed.
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Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
|
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Standing Balance - Critical Point in Distance
Periodo de tiempo: Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
|
Standing balance was measured using a force plate (AMTI, Watertown, MA, USA) from which centre of pressure (COP) trajectories were derived at a sampling frequency of 100Hz.
Participants stood on the force plate during the following two conditions: normal stance (feet hip-width apart) with eyes open and eyes closed.
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Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Balance Confidence
Periodo de tiempo: Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
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Activity-Specific Balance Confidence (ABC) scale measures balance confidence during sixteen activities of progressive difficulty, such as going up and down stairs, reaching for objects and walking in crowded areas {Powell, 1995 #5}.
It asks subjects to rate their level of confidence in performing an activity without losing balance on an 11-point scale ranging from 0% (no confidence) to 100% (completely confident).
The score is calculated as the average score for each item.
This questionnaire has been shown to be sensitive to detect changes in function following rehabilitation {Myers, 1998 #6} and has proven internal consistency and test-retest reliability {Powell, 1995 #5}.
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Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
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Fear of Falling
Periodo de tiempo: Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
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The Falls Efficacy Scale International (FESI) assesses fear of falling during a range of physical and social activities {Yardley, 2005 #1}.
It asks about an individual's concern about the possibility of following during participation in sixteen common activities, such as cleaning the house, ascending and descending stairs and walking in various environmental conditions.
Answers range from 1, "not at all" concerned, to 4, "very" concerned, on a 4-point scale, and score is calculated as the average response.
This questionnaire has been shown to have excellent internal and test-retest reliability {Yardley, 2005 #1}.
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Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
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Confidence in Disease Management
Periodo de tiempo: Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
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The COPD Self-Efficacy Scale evaluates level of confidence in ability to manage or avoid breathing difficulty during a range of situations such as feeling frustrated and lifting heavy objects {Wigal, 1991 #3}.
Possible answers range from "very confident" (5 points) to "not at all confident" (1 point) and the average score per question is calculated.
This scale has been shown to have excellent internal consistency and good test-retest reliability.
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Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michelle D Smith, PhD, The University of Queensland
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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 abril de 2009
Finalización primaria (Actual)
1 de junio de 2009
Finalización del estudio (Actual)
1 de diciembre de 2009
Fechas de registro del estudio
Enviado por primera vez
17 de marzo de 2009
Primero enviado que cumplió con los criterios de control de calidad
17 de marzo de 2009
Publicado por primera vez (Estimar)
18 de marzo de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
5 de septiembre de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
26 de agosto de 2014
Última verificación
1 de agosto de 2014
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- B2009:007
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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