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Respiratoy Muscle Strength in Patients With Multiple System Atrophy

Primary Purpose

Multiple System Atrophy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Assesment
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Multiple System Atrophy focused on measuring Multiple System Atrophy, Respiratory Muscle Strength, Sniff Nasal Inspiratory Pressure

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Marmara University Faculty of Health Sciences

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Assesment of MSA patients and healthy controls

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
FEV1/FVC
FEV1/FVC is the ratio of FEV1 to FVC. In healthy adults, this should be approximately 70-80% (declining with age).
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.

Full Information

First Posted
February 25, 2020
Last Updated
March 25, 2021
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT04287270
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 2, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
February 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple System Atrophy
Keywords
Multiple System Atrophy, Respiratory Muscle Strength, Sniff Nasal Inspiratory Pressure

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Assesment of MSA patients and healthy controls
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Assesment
Intervention Description
Evaluations which explained in the arms section will be made as described.
Primary Outcome Measure Information:
Title
Maximal inspiratory mouth pressure (PImax)
Description
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.
Time Frame
15 minutes
Title
Sniff nasal inspiratory pressure (SNIP)
Description
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.
Time Frame
10 minutes
Title
Maximal expiratory mouth pressure (PEmax)
Description
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.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Forced vital capacity (FVC)
Description
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.
Time Frame
15 minutes
Title
Forced expiratory volume in 1 second (FEV1)
Description
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.
Time Frame
15 minutes
Title
FEV1/FVC
Description
FEV1/FVC is the ratio of FEV1 to FVC. In healthy adults, this should be approximately 70-80% (declining with age).
Time Frame
15 minutes
Title
Peak expiratory flow (PEF)
Description
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.
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Semra Oguz, PT, PhD
Organizational Affiliation
Marmara University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Begum Unlu, PT, MSc
Organizational Affiliation
Marmara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University Faculty of Health Sciences
City
Istanbul
State/Province
Maltepe
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Respiratoy Muscle Strength in Patients With Multiple System Atrophy

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