Multiple Sclerosis and Respiratory and Functional Capacity

Comparison of Respiratory, Physical Activity and Functional Capacities of Patients wıth Mild Relapsing Remitting Multiple Sclerosis and Healthy Controls

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05697523

Enrollment

Registered

2023-01-26

Start date

2020-01-01

Completion date

2021-01-01

Last updated

2023-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

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

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.

Detailed description

Interventions

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

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

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

Patient group - Inclusion Criteria: * 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. Healthy group - Inclusion Criteria: * Being between the ages of 18-60. * To be willing to participate in the study. Patient group -

Exclusion criteria

* 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 Healthy group -

Design outcomes

Primary

Measure	Time frame	Description
International Physical Activity Questionnaire - Short Form	Baseline	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.
Pulmonary Function Tests- FEV1/FVC	Baseline	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.
Pulmonary Function Tests- FVC	Baseline	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.
Pulmonary Function Tests- FEV1	Baseline	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.
Pulmonary Function Tests- PEF	Baseline	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.
Pulmonary Function Tests- MVV	Baseline	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.
Functional Capacity	Baseline	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.

Secondary

Measure	Time frame	Description
Expanded Disability Status Scale	Baseline	The Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The scale is based on a neurological examination by a clinician. It has steps from 0 to 10. The higher scores indicate higher neurological disability.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026