Respiratoy Muscle Strength in Patients With Multiple System Atrophy

NCT ID: NCT04287270

Last Updated: 2021-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-02
• Study Completion Date: 2021-02-26

Brief Summary

The purpose of this study is; compare respiratory function parameters and respiratory muscle strength in patients with MSA compare to healthy controls, and to evaluate the results of SNIP and PImax in measuring inspiratory muscle strength in MSA patients.

Detailed Description

Multiple system atrophy (MSA) is a sporadic, neurodegenerative disease that begins in adulthood, progressive, unexplained. Brain stem degeneration is thought to play a role in respiratory symptoms such as stridor, sleep-related respiratory disturbances and respiratory failure in MSA patients. Respiratory disorders were emphasized and evaluated in MSA during the studies. However, the pattern of pulmonary anomalies or the performance of the inspiratory muscles is not well defined in the MSA.

Inspiratory muscle strength is assessed by voluntary or involuntary tests. The most commonly used reference values are the known maximal inspiratory mouth pressure (PImax) measurement for ease of use. In people with neuromuscular disease, the influence of the orofacial muscles can cause air leakage from the mouth. As a result, low values may be due to air escape which caused by true respiratory muscle weakness, submaximal effort or weakness of the facial muscles.

The purpose of this study is; compare respiratory function parameters and respiratory muscle strength in patients with MSA compare to healthy controls, and to evaluate the results of SNIP and MIP in measuring inspiratory muscle strength in MSA patients.

For this purpose; demographic information (sex, age, occupation, height, body weight ...), clinical and medical status, diagnosis date and Mini Mental Status Scale data of all participants will be recorded at the visit. Inspiratory muscle strength will be evaluated with sniff nasal inspiratory pressure and maximal inspiratory mouth pressure. Expiratory muscle strength will be evaluated with maximal expiratory mouth pressure (PEmax).

Conditions

Multiple System Atrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Assesment of MSA patients and healthy controls

Demographic information (sex, age, occupation, height, bodyweight ...), clinical and medical status, diagnosis date and Mini-Mental Status Scale data of all participants will be recorded at the first visit. Inspiratory muscle strength will be evaluated with sniff nasal inspiratory pressure and maximal inspiratory mouth pressure, expiratory muscle strength will be evaluated with expiratory mouth pressure. Also, the pulmonary function test will be applied.

Group Type: OTHER

Assesment

Intervention Type: OTHER

Evaluations which explained in the arms section will be made as described.

Interventions

Assesment

Evaluations which explained in the arms section will be made as described.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Being between 40-80 years old
• Have been diagnosed with MSA
• Being under drug treatment
• Being enlightened to participate in the study and filling in the consent form
• Respiratory disease or no history of occupational exposure to affect the respiratory system
• The absence of any physical or mental disability that will prevent the implementation of the tests
• Mini Mental Test score> 24

Exclusion Criteria

• Any history of neuromuscular disease other than MSA
• Having a diagnosis of psychiatric illness
• Chronic obstructive pulmonary disease (COPD) diagnosis
• The patient is not cooperative
• dementia
• Nasal congestion

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Semra Oguz, PT, PhD

Role: STUDY_DIRECTOR

Marmara University

Begum Unlu, PT, MSc

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Locations

Marmara University Faculty of Health Sciences

Istanbul, Maltepe, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SAG-B-241018-0566

Identifier Type: -

Identifier Source: org_study_id