Clinical trial NCT04042675: The Effects of Respiratory Muscle Strength in Parkinson Disease
Official title: The Effects of Respiratory Muscle Strength on Exercise Capacity, Fatigue and Physical Activity Level in Patients With Parkinson Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: parkinson disease
respiratuary muscle strength
physical activity level
fatigue
exercise capacity
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of Respiratory Muscle Strength
timeFrame: baseline
measure: Evaluation of Exercise Capacity
timeFrame: baseline
measure: Evaluation of Fatigue
timeFrame: baseline
measure: Evaluation of Physical Activity Level
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Emel Mete
Study officials:
References: