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The Effects of Respiratory Muscle Strength in Parkinson Disease

Completed
Conditions
Parkinson Disease
Interventions
Diagnostic Test: observational study
Registration Number
NCT04042675
Lead Sponsor
Istanbul Medeniyet University
Brief Summary

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.

Detailed Description

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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Control groupobservational studyhealthy individuals between the ages of 40-75 and without any neurological disorders.
parkinson groupobservational studyparkinson's patients aged between 40-75 years and 1-3 according to Hoehn-Yahr stage.
Primary Outcome Measures
NameTimeMethod
Evaluation of Respiratory Muscle Strengthbaseline

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 Physical Activity Levelbaseline

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

Evaluation of Exercise Capacitybaseline

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 Fatiguebaseline

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Emel Mete

🇹🇷

Istanbul, Turkey

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