Respiratoy Muscle Strength in Patients With Multiple System Atrophy

NCT04287270 | Completed

• 1 other identifier: SAG-B-241018-0566
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple System Atrophy

Keywords

Multiple System Atrophy; Respiratory Muscle Strength; Sniff Nasal Inspiratory Pressure

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Forced vital capacity (FVC)

  15 minutes

• Forced expiratory volume in 1 second (FEV1)

  15 minutes

• FEV1/FVC

  15 minutes

• Peak expiratory flow (PEF)

  15 minutes

Study Arms (1)

Assesment of MSA patients and healthy controls

OTHER

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.

Other: Assesment

Interventions

Assesment OTHER

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

Assesment of MSA patients and healthy controls

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Faculty of Health Sciences

Istanbul, Maltepe, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple System Atrophy

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Semra Oguz, PT, PhD

  Marmara University

  STUDY DIRECTOR

• Begum Unlu, PT, MSc

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 27, 2020
• Study Start: February 2, 2019
• Primary Completion: July 1, 2020
• Study Completion: February 26, 2021
• Last Updated: March 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)