The Effects of Respiratory Muscle Strength in Parkinson Disease

NCT04042675 | Completed

• 1 other identifier: 25.07.2019/87
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

parkinson disease; respiratuary muscle strength; physical activity level; fatigue; exercise capacity

Outcome Measures

Primary Outcomes (4)

• 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.

  baseline

• 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).

  baseline

• 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.

  baseline

• 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). 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

Study Arms (2)

parkinson group

parkinson's patients aged between 40-75 years and 1-3 according to Hoehn-Yahr stage.

Diagnostic Test: observational study

Control group

healthy individuals between the ages of 40-75 and without any neurological disorders.

Diagnostic Test: observational study

Interventions

observational study DIAGNOSTIC_TEST

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; parkinson group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Emel Mete

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease; Fatigue

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 2, 2019
• Study Start: July 25, 2019
• Primary Completion: October 20, 2020
• Study Completion: December 5, 2020
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)