- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01930513
Exercise Capacity and Daily Physical Activity in Obese Subjects With Treated Obstructive Sleep Apnea
Obesity is very common worldwide and breathing problems at night (obstructive sleep apnea, OSA) are common in obesity. Despite the best treatment, obesity and OSA are linked to early death from heart problems. They are also associated with lower levels of physical activity. Exercise strategies for weight loss, increasing physical activity and improving fitness are needed for obesity. In Obese individuals with OSA
- The investigators will compare corridor walking tests compared to laboratory exercise tests. The null hypothesis is that the peak oxygen uptake achieved and the cardiopulmonary response during both the six-minute walk test and Incremental Shuttle Walk Test would not be different from that observed during an Incremental Treadmill Test.
- The investigators will investigate whether cycling or walking uses more calories for the same intensity. We hypothesise that cycling (weight supported) will be endured for long.
- The investigators will compare commonly used exercise tests with levels of daily physical activity.
The information from these three projects will help us set up the optimal exercise program for obese individuals.
Descripción general del estudio
Estado
Condiciones
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
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Obstructive Sleep Apnea
- Obesity BMI>30
- Controlled on Continuous Positive Airway Pressure for three months
Exclusion Criteria:
- cardiac co-morbidity e.g ischaemic heart disease, chronic heart failure, valvular heart disease
- pulmonary co-morbidity
- neurological condition limiting the ability to perform walking or cycling
- orthopaedic condition limiting the ability to perform walking or cycling
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Peak oxygen uptake (Peak VO2) measured at the end of the Incremental Shuttle Walk Test (ISWT)
Periodo de tiempo: All outcome measures will be performed within four weeks of each other
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Two Incremental Shuttle Walk tests will be performed within two hours on the same day with expired gas analysis measured by a portable gas analyser.
An ISWT is conducted over a 10m course and the speed is externally paced and increases each minute.
The participant is asked to continue until they are either too breathless or too tired to continue.
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All outcome measures will be performed within four weeks of each other
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Six minute walk test (6MWT)
Periodo de tiempo: Four weeks
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The 6MWT will be performed over a 30 m level, straight course within an enclosed corridor.
The test protocol described by the American Thoracic Society will be modified to include standardized encouragement every 15 seconds to recommence walking if the participant chooses to rest during the test.
Participants will be familiarized with the test prior to participating in the study and, therefore, only one test will be performed.
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Four weeks
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Incremental Treadmill Test (ITM)
Periodo de tiempo: Four weeks
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A maximal treadmill test will be performed once with expired gas analysis.
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Four weeks
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Incremental cycle test (ICE)
Periodo de tiempo: Four weeks
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A maximal symptom limited cardio-pulmonary exercise test on a cycle ergometer.
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Four weeks
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Endurance cycle ergometer
Periodo de tiempo: Four weeks
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Two endurance cycle tests will performed at 60% and 80% of the maximal peak oxygen obtained on either the ICE or ITM
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Four weeks
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Endurance treadmill test
Periodo de tiempo: Four weeks
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Constant speed endurance treadmill test will be performed at 60% and 80% of the peak oxygen uptake achieved on either the ITM or ICE to symptom limitation
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Four weeks
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Daily physical activity
Periodo de tiempo: Four weeks
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A sensewear armband will be worn for 7 days and only taken off for showering/bathing.
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Four weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Roger S Goldstein, MBChB, West Park Healthcare Centre
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RG2010OSA
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