Clinical Trials Directory

Trials / Completed

CompletedNCT04042675

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

Status
Completed
Phase
Study type
Observational
Enrollment
60 (actual)
Sponsor
Istanbul Medeniyet University · Academic / Other
Sex
All
Age
45 Years – 75 Years
Healthy volunteers
Accepted

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).

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTobservational studyThere 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.

Timeline

Start date
2019-07-25
Primary completion
2020-10-20
Completion
2020-12-05
First posted
2019-08-02
Last updated
2021-08-26

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04042675. Inclusion in this directory is not an endorsement.