Clinical trial NCT04287270: Respiratoy Muscle Strength in Patients With Multiple System Atrophy
Official title: Evaluation of Respiratory Muscle Strength in Patients With Multiple System Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple System Atrophy
Keywords: Multiple System Atrophy
Respiratory Muscle Strength
Sniff Nasal Inspiratory Pressure
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 19
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multiple system atrophy patients; Inspiratory muscle strength will be evaluated with sniff nasal inspiratory pressure (SNIP) and maximal inspiratory mouth pressure (PImax). Expiratory muscle strength will be evaluated maximal expiratory mouth pressure (PEmax). Pulmonary function test will be performed.

Healthy Controls: Inspiratory muscle strength will be evaluated with sniff nasal inspiratory pressure (SNIP) and maximal inspiratory mouth pressure (PImax). Expiratory muscle strength will be evaluated maximal expiratory mouth pressure (PEmax). Pulmonary function test will be performed.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: Maximal inspiratory mouth pressure (PImax)
timeFrame: 15 minutes
measure: Sniff nasal inspiratory pressure (SNIP)
timeFrame: 10 minutes
measure: Maximal expiratory mouth pressure (PEmax)
timeFrame: 15 minutes
Secondary outcomes:
measure: Forced vital capacity (FVC)
timeFrame: 15 minutes
measure: Forced expiratory volume in 1 second (FEV1)
timeFrame: 15 minutes
measure: FEV1/FVC
timeFrame: 15 minutes
measure: Peak expiratory flow (PEF)
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Faculty of Health Sciences
state: Maltepe
Study officials:
affiliation: Marmara University
name: Semra Oguz, PT, PhD
role: STUDY_DIRECTOR
affiliation: Marmara University
name: Begum Unlu, PT, MSc
role: PRINCIPAL_INVESTIGATOR
References: