- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04042675
The Effects of Respiratory Muscle Strength in Parkinson Disease
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
Condiciones
Intervención / Tratamiento
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
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Istanbul, Pavo, 34000
- Emel Mete
-
-
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:
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
¿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
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
- 25.07.2019/87
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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-
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