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The Effects of Respiratory Muscle Strength in Parkinson Disease

25 de agosto de 2021 actualizado por: Emel Mete, Istanbul Medeniyet University

The Effects of Respiratory Muscle Strength on Exercise Capacity, Fatigue and Physical Activity Level in Patients With Parkinson Disease

The aim of this study was to compare respiratory muscle strength, motor performance, fatigue and physical activity levels between patients with Parkinson disease and the healthy people and the other aim is to investigate the effects of respiratory muscle strength on exercise capasity, fatigue and physical activity levels in patients with Parkinson's disease.

There will be two groups in this study. One of the groups will consist of 30 patients aged between 40-75 years and 1-3 according to Hoehn-Yahr stage. The other group will consist of 30 healthy individuals between the ages of 40-75 and without any neurological disorders. Respiratory muscle strength, exercise capacity, fatigue and physical activity levels will be assessed.

Descripción general del estudio

Estado

Terminado

Descripción detallada

Assessment methods will include: Mouth pressure measuring for assessment of respiratory muscle strength, timed up and go (TUG) and ten meter walk test (10MWT) to assess exercise capasity, fatigue impact scale (FIS) and fatigue severity scale (FSS) to assess fatigue and the international physical activity questionnaire (IPAQ) will be used to assess physical activity levels of participants.

There will be two groups in this study. One of the groups will consist of 30 parkinson's patients aged between 40-75 years and 1-3 according to Hoehn-Yahr stage. The other group will consist of 30 healthy individuals between the ages of 40-75 and without any neurological disorders.

Including criterias:

For patients with Parkinson disease

  • diagnosed with Parkinson disease
  • Aged between 45-75 years
  • 1-3 according to Hoehn-Yahr scale For health group
  • Aged between 45-75 years
  • Without any neurological disorder

Evaluation of Respiratory Muscle Strength: Maximum inspiratory (MIP) and expiratory pressures (MEP) are measurements of pressures against the closed airway to assess the strength of respiratory muscles. MIP and MEP pressures are noninvasive tests that show indirect respiratory muscle strength. Spirometry device (Carefusion /Micro RPM) will be used to assess MIP and MEP. The maximum inspiratory and expiratory valve (shutter) that closes the airway during the maximum oral pressure measured during the maximum breath.

Evaluation of Exercise Capacity: Exerise capacity of participants will assess with TUG and 10MWT tests.

Time up and go test (TUG) assesses mobility, balance, walking ability and risk of falling. The test is performed by the person getting up from a chair, walking 3 meters, turning around himself, walking back to the chair and sitting again.

Ten meter walk test (10MWT): In the test, the person is asked to walk at his / her normal speed within a pre-measured area of 10 meters. Two measurements are taken and the best value is recorded in meters per second (m / sec).

Evaluation of Fatigue: Fatigue impact scale (FIS) and Fatigue severity scale (FSS) will be used.

Fatigue impact scale (FIS) consists of forty questions. The first 10 items assess cognitive status, the second 10 items evaluate physical status, and the third 20 items evaluate psychological status. Each question is scored between 0 (no problem) and 4 (maximum problem). The highest score is 160. Higher scores show more fatigue.

Fatigue severity scale (FSS) consists of 9 questions. Each question is evaluated with a scale of 1 to 7 points. 1 = Strongly disagree, 7 = Strongly agree. Minimum score 9, maximum score 63.High scores indicate fatigue.

Evaluation of Physical Activity Level: International Physical Activiy Questionnaire (IPAQ) will be used.

The long form of the IPAQ questionnaire is used to gather information about recreational activities such as home and field activities, occupational transport, sedentary activities. The calculation of the total score for the IPAQ long form includes the sum of time (minutes) and frequency (days) for all types of activity in all areas. Scoring is done according to activity (walking, moderate activity, severe activity). From these calculations, a score in MET-minutes is obtained. A MET-minute is calculated by multiplying the minute of activity performed by the MET score. MET-min x (person's body weight kg / 60 kg).

Tipo de estudio

De observación

Inscripción (Actual)

60

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

      • Istanbul, Pavo, 34000
        • Emel Mete

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

45 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Persons who meet the inclusion criteria and who volunteered to participate in the study, who applied to the Neurology outpatient clinic of the Medical Faculty Hospital will be included in the study.

Descripción

Inclusion Criteria:

For patients with Parkinson disease

  • diagnosed with Parkinson disease
  • Aged between 45-75 years
  • 1-3 according to Hoehn-Yahr scale For health group
  • Aged between 45-75 years
  • Without any neurological disorder

Exclusion Criteria:

For patients with Parkinson disease

  • not diagnosed with Parkinson disease
  • 4-5 according to Hoehn-Yahr scale For health group
  • With a neurological disorder

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
parkinson group
parkinson's patients aged between 40-75 years and 1-3 according to Hoehn-Yahr stage.
There will be two groups in this study. One of the groups will consist of 30 parkinson's patients aged between 40-75 years and 1-3 according to Hoehn-Yahr stage. The other group will consist of 30 healthy individuals between the ages of 40-75 and without any neurological disorders. Participants' respiratory muscle strength, exercise capasity, fatigue and physical activity levels will be assessed. All asessements will done for only one time.
Control group
healthy individuals between the ages of 40-75 and without any neurological disorders.
There will be two groups in this study. One of the groups will consist of 30 parkinson's patients aged between 40-75 years and 1-3 according to Hoehn-Yahr stage. The other group will consist of 30 healthy individuals between the ages of 40-75 and without any neurological disorders. Participants' respiratory muscle strength, exercise capasity, fatigue and physical activity levels will be assessed. All asessements will done for only one time.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Evaluation of Respiratory Muscle Strength
Periodo de tiempo: baseline
Maximum inspiratory (MIP) and expiratory pressures (MEP) are measurements of pressures against the closed airway to assess the strength of respiratory muscles. MIP and MEP pressures are noninvasive tests that show indirect respiratory muscle strength. Spirometry device (Carefusion /Micro RPM) will be used to assess MIP and MEP. The maximum inspiratory and expiratory valve (shutter) that closes the airway during the maximum oral pressure measured during the maximum breath.
baseline
Evaluation of Exercise Capacity
Periodo de tiempo: baseline

Exerise capacity of participants will assess with TUG and 10MWT tests. Time up and go test (TUG) assesses mobility, balance, walking ability and risk of falling. The test is performed by the person getting up from a chair, walking 3 meters, turning around himself, walking back to the chair and sitting again.

Ten meter walk test (10MWT): In the test, the person is asked to walk at his / her normal speed within a pre-measured area of 10 meters. Two measurements are taken and the best value is recorded in meters per second (m / sec).

baseline
Evaluation of Fatigue
Periodo de tiempo: baseline

Fatigue impact scale (FIS) and Fatigue severity scale (FSS) will be used. Fatigue impact scale (FIS) consists of forty questions. The first 10 items assess cognitive status, the second 10 items evaluate physical status, and the third 20 items evaluate psychological status. Each question is scored between 0 (no problem) and 4 (maximum problem). The highest score is 160. Higher scores show more fatigue.

Fatigue severity scale (FSS) consists of 9 questions. Each question is evaluated with a scale of 1 to 7 points. 1 = Strongly disagree, 7 = Strongly agree. Minimum score 9, maximum score 63.High scores indicate fatigue.

baseline
Evaluation of Physical Activity Level
Periodo de tiempo: baseline

International Physical Activiy Questionnaire (IPAQ) will be used. The long form of the IPAQ questionnaire is used to gather information about recreational activities such as home and field activities, occupational transport, sedentary activities. The calculation of the total score for the IPAQ long form includes the sum of time (minutes) and frequency (days) for all types of activity in all areas. Scoring is done according to activity (walking, moderate activity, severe activity). From these calculations, a score in MET-minutes is obtained. A MET-minute is calculated by multiplying the minute of activity performed by the MET score. MET-min x (person's body weight kg / 60 kg). The following values are used for the analysis of IPAQ data.

- Walking = 3.3 MET - Moderate physical activity = 4.0 MET - Severe physical activity = 8.0 MET

baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este 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 (Actual)

25 de julio de 2019

Finalización primaria (Actual)

20 de octubre de 2020

Finalización del estudio (Actual)

5 de diciembre de 2020

Fechas de registro del estudio

Enviado por primera vez

29 de julio de 2019

Primero enviado que cumplió con los criterios de control de calidad

1 de agosto de 2019

Publicado por primera vez (Actual)

2 de agosto de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de agosto de 2021

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

25 de agosto de 2021

Última verificación

1 de agosto de 2021

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

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. .

Ensayos clínicos sobre Enfermedad de Parkinson

Ensayos clínicos sobre observational study

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