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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02757157
Comparison of Walking in Water and on Land in People With Chronic Obstructive Pulmonary Disease (COPD)
Determining the Metabolic Load of Walking in Water Compared to Walking on Land in People With COPD, Who Are Normal Weight and Obese, Compared to Peak Exercise Metabolic Response: a Prospective, Randomised Cross-over Pilot Trial
The purpose of this study is to evaluate the metabolic load during a single session of moderate intensity walking in water compared to walking on land (over-ground) in people with chronic obstructive pulmonary disease (COPD) who are normal weight and obese, compared with peak exercise metabolic response.
The hypothesis is that the metabolic load of walking at a moderate intensity in water will be greater than walking on land.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Horn, Países Bajos
- Centre of intergrated rehabilitation for chronic organ failure
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- diagnosis of COPD (FEV1/FVC <0.7) in a clinically stable state (no acute exacerbation of COPD within the previous 4 weeks)
- accepting of walking in water
- BMI >/= 21 kg/m2
Exclusion Criteria:
- long-term oxygen therapy
- contraindications to entering a hydrotherapy pool
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: COPD (normal weight)
People with COPD (BMI 21 kg/m2 to 29 kg/m2)
|
Participants will walk in the water for 15 minutes at an intensity rating of five on the modified Borg scale for dyspnoea or perceived exertion, whichever is the highest. Walking intensity will be measured every three minutes during each walking session. If the intensity level is reported as below five, participants will be encouraged to increase the intensity by increasing their walking speed. During walking in water, VO2 and VE will be measured breath-by-breath using the Oxycon mobile. Every three minutes during the walking, heart rate, oxygen saturation, dyspnoea and exertion will be measured. Participants will walk on land for 15 minutes at an intensity rating of five on the modified Borg scale for dyspnoea or perceived exertion, whichever is the highest. Walking intensity will be measured every three minutes during each walking session. If the intensity level is reported as below five, participants will be encouraged to increase the intensity by increasing their walking speed. During walking on land, VO2 and VE will be measured breath-by-breath using the Oxycon mobile. Every three minutes during the walking, heart rate, oxygen saturation, dyspnoea and exertion will be measured. |
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Experimental: COPD (obese)
People with COPD (BMI >/= 30 kg/m2)
|
Participants will walk in the water for 15 minutes at an intensity rating of five on the modified Borg scale for dyspnoea or perceived exertion, whichever is the highest. Walking intensity will be measured every three minutes during each walking session. If the intensity level is reported as below five, participants will be encouraged to increase the intensity by increasing their walking speed. During walking in water, VO2 and VE will be measured breath-by-breath using the Oxycon mobile. Every three minutes during the walking, heart rate, oxygen saturation, dyspnoea and exertion will be measured. Participants will walk on land for 15 minutes at an intensity rating of five on the modified Borg scale for dyspnoea or perceived exertion, whichever is the highest. Walking intensity will be measured every three minutes during each walking session. If the intensity level is reported as below five, participants will be encouraged to increase the intensity by increasing their walking speed. During walking on land, VO2 and VE will be measured breath-by-breath using the Oxycon mobile. Every three minutes during the walking, heart rate, oxygen saturation, dyspnoea and exertion will be measured. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Breath-by-breath oxygen consumption (VO2)
Periodo de tiempo: Day of assessment during study measurement period (15 minutes)
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Day of assessment during study measurement period (15 minutes)
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Minute ventilation (VE)
Periodo de tiempo: Day of assessment during study measurement period (15 minutes)
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Day of assessment during study measurement period (15 minutes)
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Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
|---|---|
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Dyspnoea, measured by the modified Borg 0-10 category ratio scale
Periodo de tiempo: Day of assessment during study measurement period (15 minutes)
|
Day of assessment during study measurement period (15 minutes)
|
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Exertion, measured by the modified Borg 0-10 category ratio scale
Periodo de tiempo: Day of assessment during study measurement period (15 minutes)
|
Day of assessment during study measurement period (15 minutes)
|
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Oxygen saturation
Periodo de tiempo: Day of assessment during study measurement period (15 minutes)
|
Day of assessment during study measurement period (15 minutes)
|
|
Heart rate
Periodo de tiempo: Day of assessment during study measurement period (15 minutes)
|
Day of assessment during study measurement period (15 minutes)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Martijn A Spruit, PhD, Centre of integrated rehabilitation for chronic organ failure
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 (Actual)
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
- ERS STRTF 2015 - 9368
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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