Respiratoy Muscle Strength in Patients With Multiple System Atrophy

Multiple System Atrophy Clinical Trial

Official title:

Evaluation of Respiratory Muscle Strength in Patients With Multiple System Atrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04287270
• Other study ID #: SAG-B-241018-0566
• Status: Completed
• Phase: N/A
• Start date: February 2, 2019
• Est. completion date: February 26, 2021

Study information

• Verified date: March 2021
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: February 26, 2021
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Multiple System Atrophy
• Shy-Drager Syndrome

Intervention

Other:
• Assesment
Evaluations which explained in the arms section will be made as described.

Locations

Country	Name	City	State
Turkey	Marmara University Faculty of Health Sciences	Istanbul	Maltepe

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal inspiratory mouth pressure (PImax)	Maximum inspiratory pressure (PImax) is the classic volitional test of inspiratory muscle strength. It is measured as the highest mouth pressure (cmH2O) sustained for 1 s during a maximum inspiratory effort against a quasi occlusion. Evaluation is carried out according to American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria.	15 minutes
Primary	Sniff nasal inspiratory pressure (SNIP)	Sniff nasal inspiratory pressure (SNIP) measurement is a volitional noninvasive assessment of inspiratory muscle strength. A maximum of 10 sniffs is generally used. It is a simple procedure consisting of measuring peak nasal pressure (cmH2O) as a result of maximal sniff performance through from the end of expiration with the open nostril while the other one is closed.	10 minutes
Primary	Maximal expiratory mouth pressure (PEmax)	Maximum expiratory pressure (PEmax) is the classic volitional test of expiratory muscle strength. It is measured as the highest mouth pressure (cmH2O) sustained for 1 s during a maximum expiratory effort against a quasi occlusion. Evaluation is carried out according to American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria.	15 minutes
Secondary	Forced vital capacity (FVC)	Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters. FVC is the most basic maneuver in spirometry tests. Pulmonary function test is performed to determine FVC.	15 minutes
Secondary	Forced expiratory volume in 1 second (FEV1)	Forced expiratory volume in 1 second (FEV1) is the volume of air that can forcibly be blown out in first 1 second, after full inspiration. Pulmonary function test is performed to determine FEV1.	15 minutes
Secondary	FEV1/FVC	FEV1/FVC is the ratio of FEV1 to FVC. In healthy adults, this should be approximately 70-80% (declining with age).	15 minutes
Secondary	Peak expiratory flow (PEF)	Peak expiratory flow (PEF) is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration, measured in liters per minute or in liters per second. Pulmonary function test is performed to determine PEF.	15 minutes