Multiple Sclerosis and Respiratory and Functional Capacity

NCT05697523 | Completed

• 1 other identifier: 60116787-020/92286
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

It is known that respiratory functions, physical activities and functional capacities of Multiple Sclerosis (MS) patients decrease with the progression of the disease. However, there is not enough information about the severity of the effects of these parameters in mild Relapsing-Remitting Multiple Sclerosis (RRMS) patients. Our aim in this study is to compare the respiratory functions, physical activities and functional capacities of mild RRMS patients with healthy controls and to examine the relationship between them.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; functional capacity; physical activity; respiratory system; Relapsing-Remitting

Outcome Measures

Primary Outcomes (7)

• Pulmonary Function Tests- FEV1/FVC

  Evaluation of FEV1/FVC ratio MicroQuark® computer-based USB spirometer will be used to assess the respiratory function of the participants. The person will be asked to take a few normal breaths followed by as deep a breath as possible and instructed to exhale forcefully and quickly without waiting. The test will be terminated by instructing the participant to take a deep breath after exhaling for at least six seconds.

  Baseline

• Pulmonary Function Tests- FVC

  Evaluation of Forced Vital Capacity (FVC) MicroQuark® computer-based USB spirometer will be used for FVC evaluation. The person will be asked to take a few normal breaths, then take as deep a breath as possible, and then exhale forcefully and quickly without waiting. The test will be terminated by instructing the participant to take a deep breath after exhaling for at least six seconds.

  Baseline

• Pulmonary Function Tests- FEV1

  Evaluation of Forced Expiratory Volume in 1 second (FEV1) MicroQuark® computer-based USB spirometer will be used for FEV1 evaluation. The person will be asked to take a few normal breaths, then take as deep a breath as possible, and then exhale forcefully and quickly without waiting. The test will be terminated by instructing the participant to take a deep breath after exhaling for at least six seconds.

  Baseline

• Pulmonary Function Tests- PEF

  Evaluation of Peak Expiratory Flow (PEF) MicroQuark® computer-based USB spirometer will be used for PEF evaluation. The person will be asked to take a few normal breaths, then take as deep a breath as possible, and then exhale forcefully and quickly without waiting. The test will be terminated by instructing the participant to take a deep breath after exhaling for at least six seconds.

  Baseline

• Pulmonary Function Tests- MVV

  Maximum voluntary ventilation (MVV) MicroQuark® computer-based USB spirometer will be used for MVV evaluation. Then the participant will take the disposable bacteria filter mouthpiece between his lips and holds it tightly. The person will be asked to deeply and rapidly breaths for 10 to 15 seconds.

  Baseline

• Functional Capacity

  The 6-minute walk test (6MWT) was used to measure functional capacity. In the test, the participant was asked to walk for 6 minutes as fast as possible in a 30-meter corridor, and the total distance in meters was recorded. Standard encouragement was given to the participant every 60 seconds during the test. Estimated values of participants For men; (7.57 x height(cm)) - (5.02 x age) - (1.76 x kg) - 309, for women; Calculated with the formula (2.11 x height(cm)) - (2.29 x kg) - (5.78 x age) + 667.

  Baseline

• International Physical Activity Questionnaire - Short Form

  The International Physical Activity Questionnaire-Short Form (IPAQ-SF) was used to evaluate physical activity. It was developed to evaluate the physical activities of people between the ages of 15-60 in their daily lives. It consists of seven questions in total and questions the time spent in vigorous, moderate-to-severe and walking activities. In addition, the sitting time is considered as a separate question. The Metabolic Equivalent (MET-minute) score is determined at the end of the calculation made by multiplying the MET value of the activities performed by the minute. Classification is based on the numerical data obtained. Accordingly, there are 3 activity levels: Inactive, minimal active and very active. The lowest level of physical activity is inactive and the highest level of physical activity is very active. The IPAQ is a valid and reliable test in MS patients.

  Baseline

Secondary Outcomes (1)

• Expanded Disability Status Scale

  Baseline

Study Arms (2)

Patient group

people with mild RRMS

Other: Expanded Disability Status Scale, pulmonary function test, International Physical Activity Questionnaire - Short Form, 6 minute walk test

Healthy group

healthy people

Other: Expanded Disability Status Scale, pulmonary function test, International Physical Activity Questionnaire - Short Form, 6 minute walk test

Interventions

Expanded Disability Status Scale, pulmonary function test, International Physical Activity Questionnaire - Short Form, 6 minute walk test OTHER

Expanded Disability Status Scale, pulmonary function test, International Physical Activity Questionnaire - Short Form, 6 minute walk test

Healthy group; Patient group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Multiple Sclerosis patients who applied to Pamukkale University Hospital Neurology Clinic were included in this study.

You may qualify if:

• Having a definitive diagnosis of RRMS according to the 2017 McDonald criteria
• Being between the ages of 18-60.
• To be willing to participate in the study.
• EDSS score between 0-3.
• Being between the ages of 18-60.
• To be willing to participate in the study.

You may not qualify if:

• Have other neurological, orthopedic and systemic problems
• Having a relapse 30 days before or during the study
• Changes in medication use in the past 30 days
• Have neurological, orthopedic and systemic problems

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead
• Pamukkale University: collaborator

Study Sites (1)

Pamukkale University

Denizli, 20200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Interventions

Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 26, 2023
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)