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临床试验/NCT05697523
NCT05697523已完成不适用

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

Nigde Omer Halisdemir University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Pulmonary Function Tests- MVV

研究概览

简要总结

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.

详细描述

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.

Forty individuals diagnosed with RRMS between the ages of 18-60 and 40 healthy individuals with similar demographic characteristics were included in the study.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Having a definitive diagnosis of RRMS according to the 2017 McDonald criteria
  • Being between the ages of 18-
  • To be willing to participate in the study.
  • EDSS score between 0-
  • Healthy group - Inclusion Criteria:
  • Being between the ages of 18-
  • To be willing to participate in the study.
  • Patient group -

排除标准

  • 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 - Exclusion Criteria:
  • Have neurological, orthopedic and systemic problems

结局指标

主要结局

Pulmonary Function Tests- MVV

时间窗: 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.

International Physical Activity Questionnaire - Short Form

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

Functional Capacity

时间窗: 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.

次要结局

  • Expanded Disability Status Scale(Baseline)

研究者

发起方
Nigde Omer Halisdemir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gürkan Demirtas

Lecturer

Nigde Omer Halisdemir University

研究点 (1)

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