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Comparison of Walking in Water and on Land in People With Chronic Obstructive Pulmonary Disease (COPD)

19 de agosto de 2021 actualizado por: Renae McNamara, European Respiratory Society

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

Tipo de estudio

Intervencionista

Inscripción (Actual)

14

Fase

  • No aplica

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

      • Horn, Países Bajos
        • Centre of intergrated rehabilitation for chronic organ failure

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

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

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: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.

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)
Day of assessment during study measurement period (15 minutes)

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Minute ventilation (VE)
Periodo de tiempo: Day of assessment during study measurement period (15 minutes)
Day of assessment during study measurement period (15 minutes)

Otras medidas de resultado

Medida de resultado
Periodo de tiempo
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)
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)
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

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

Investigadores

  • Director de estudio: Martijn A Spruit, PhD, Centre of integrated rehabilitation for chronic organ failure

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 octubre de 2016

Finalización primaria (Actual)

1 de enero de 2020

Finalización del estudio (Actual)

1 de enero de 2020

Fechas de registro del estudio

Enviado por primera vez

7 de abril de 2016

Primero enviado que cumplió con los criterios de control de calidad

27 de abril de 2016

Publicado por primera vez (Estimar)

29 de abril de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de agosto de 2021

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

19 de agosto de 2021

Última verificación

1 de agosto de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • ERS STRTF 2015 - 9368

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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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