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临床试验/NCT07672535
NCT07672535尚未招募不适用

Comparison of the Effects of High-Intensity and Low-Intensity Inspiratory Muscle Training in Individuals With Multiple Sclerosis

Istanbul University - Cerrahpasa0 个研究点目标入组 48 人开始时间: 2026年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
48
主要终点
Maximal inspiratory pressure (MIP)

研究概览

简要总结

Multiple sclerosis (MS) is a chronic disease affecting the central nervous system, characterized by inflammation, demyelination, and axonal degeneration, and primarily affects young adults. Muscle weakness, sensory disturbances, spasticity, pain, visual impairment, ataxia, fatigue, cognitive dysfunction, and respiratory complications are among the most commonly reported symptoms in individuals with MS. Although inspiratory muscle training has been shown to have beneficial effects in individuals with MS, the effects of different inspiratory muscle training intensities on respiratory muscle strength and pulmonary function have not been sufficiently investigated.

The primary aim of this study is to investigate the effectiveness and clinical feasibility of high-intensity interval inspiratory muscle training in individuals with MS. The secondary aim is to compare the effects of high-intensity interval inspiratory muscle training, low-intensity inspiratory muscle training, and conventional rehabilitation on respiratory muscle strength, pulmonary function, cough effectiveness, exercise capacity, lower extremity functional muscle strength, balance, fatigue, dysphagia severity, sleep quality, and quality of life in individuals with MS.

Participants will be randomly assigned to one of three groups: a high-intensity interval inspiratory muscle training group, a low-intensity inspiratory muscle training group, or a conventional rehabilitation group. All three groups will receive conventional rehabilitation, while the inspiratory muscle training groups will additionally receive their respective inspiratory muscle training programs. This study aims to be the first randomized controlled trial to evaluate the effects of high-intensity interval inspiratory muscle training in individuals with MS.

详细描述

Multiple sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system. Although the pathogenesis of the disease is not fully understood, genetic and environmental factors are thought to contribute to its development. Demyelinating plaques, the primary pathological hallmark of MS, are most commonly found in the optic nerves, brainstem, spinal cord, and periventricular white matter. The clinical manifestations of the disease vary depending on the regions of the central nervous system affected and the extent of inflammation and axonal demyelination. Respiratory function and respiratory muscle strength have been shown to be lower in individuals with MS compared with healthy individuals. The risk of death due to respiratory complications is approximately 12 times higher in the MS population than in the general population, and 47% of MS-related deaths are attributed to respiratory complications. These findings highlight the critical importance of early interventions targeting respiratory function.

Although inspiratory muscle training (IMT) has been shown to improve respiratory function, its effects on functional outcomes in individuals with MS have not been sufficiently investigated. However, these functional outcomes are important for improving quality of life and optimizing rehabilitation in individuals with MS. Furthermore, because studies investigating IMT in individuals with MS are limited, the optimal training protocol in terms of training frequency, intensity, and duration has not yet been clearly established. Recent studies have demonstrated that high-intensity interval IMT is effective in improving respiratory function, respiratory muscle strength, and functional capacity in individuals with chronic obstructive pulmonary disease, bronchiectasis, and heart failure, and that it is well tolerated by patients. To the best of our knowledge, no study has investigated the effects of this approach in individuals with MS.

This study is designed as a randomized controlled trial. A total of 48 individuals diagnosed with MS will be randomly assigned to one of three groups: high-intensity interval IMT, low-intensity IMT, or conventional rehabilitation. The intervention period will last 8 weeks. All three groups will receive conventional rehabilitation consisting of aerobic and resistance exercises. In addition, the IMT groups will receive either high-intensity interval IMT or low-intensity IMT. The primary outcome measures of the study are respiratory muscle strength, pulmonary function, and cough strength. Secondary outcome measures include exercise capacity, lower extremity functional muscle strength, balance, fatigue, dysphagia severity, sleep quality, and quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of multiple sclerosis (MS) according to the 2024 McDonald criteria
  • Expanded Disability Status Scale (EDSS) score ≥2 and <6
  • Age between 18 and 65 years
  • Mini-Mental State Examination (MMSE) score >24
  • Willingness to participate in the study

排除标准

  • Experiencing an MS relapse within the past three months
  • Presence of chronic cardiac or pulmonary diseases that may affect respiratory muscle strength and function, such as COPD, asthma, interstitial lung disease, or heart failure
  • Presence of pulmonary infection
  • Presence of orthopedic problems
  • Presence of psychiatric disorders
  • Pregnancy

研究组 & 干预措施

High intensity interval IMT group

Experimental

High-intensity interval IMT and conventional rehabilitation

干预措施: High intensity interval IMT (Behavioral)

Low intensity IMT group

Experimental

Low intensity IMT and conventional rehabilitation

干预措施: Low intensity IMT (Behavioral)

Conventional rehabilitation

Active Comparator

Conventional rehabilitation

干预措施: Conventional rehabilitation (Behavioral)

结局指标

主要结局

Maximal inspiratory pressure (MIP)

时间窗: From baseline to the end of the intervention at 8 weeks

In our study, respiratory muscle strength will be assessed using an electronic mouth pressure measurement device (MicroRPM Respiratory Pressure Meter). For maximal inspiratory pressure (MIP) measurement, participants will be asked to wear a nose clip and perform a maximal inspiratory effort lasting at least 1.5 seconds through a mouthpiece after maximal expiration. Measurements will be performed in a seated position with rest intervals between attempts. The highest value obtained from three consecutive trials will be recorded in cmH₂O. The best value will also be expressed as a percentage of predicted normal values according to age and sex.

Maximal expiratory pressure (MEP)

时间窗: From baseline to the end of the intervention at 8 weeks

In our study, respiratory muscle strength will be assessed using an electronic mouth pressure measurement device (MicroRPM Respiratory Pressure Meter). For maximal expiratory pressure (MEP) measurement, participants will be asked to wear a nose clip and perform a maximal expiratory effort lasting at least 1.5 seconds through a mouthpiece after maximal inspiration. Measurements will be performed in a seated position with rest intervals between attempts. The highest value obtained from three consecutive trials will be recorded in cmH₂O. The best value will also be expressed as a percentage of predicted normal values according to age and sex.

Forced Vital Capacity (FVC)

时间窗: From baseline to the end of the intervention at 8 weeks

The pulmonary function test will be performed using the COSMED Pony FX device in accordance with the American Thoracic Society and European Respiratory Society guidelines.

Forced Expiratory Volume (FEV1)

时间窗: From baseline to the end of the intervention at 8 weeks

The pulmonary function test will be performed using the COSMED Pony FX device in accordance with the American Thoracic Society and European Respiratory Society guidelines.

Tiffeneau Index (FEV1/FVC)

时间窗: From baseline to the end of the intervention at 8 weeks

The pulmonary function test will be performed using the COSMED Pony FX device in accordance with the American Thoracic Society and European Respiratory Society guidelines.

Peak Expiratory Flow (PEF)

时间窗: From baseline to the end of the intervention at 8 weeks

The pulmonary function test will be performed using the COSMED Pony FX device in accordance with the American Thoracic Society and European Respiratory Society guidelines.

Cough strength

时间窗: From baseline to the end of the intervention at 8 weeks

For assessment of cough strength, peak cough flow (PCF) will be measured using a peak flow meter (ExpiRite® Peak Flow Meter, China).

次要结局

  • Exercise capacity(From baseline to the end of the intervention at 8 weeks)
  • Lower Extremity Functional Capacity(From baseline to the end of the intervention at 8 weeks)
  • Balance(From baseline to the end of the intervention at 8 weeks)
  • Fatigue level(From baseline to the end of the intervention at 8 weeks)
  • Dysphagia severity(From baseline to the end of the intervention at 8 weeks)
  • Sleep quality(From baseline to the end of the intervention at 8 weeks)
  • The Multiple Sclerosis Quality of Life-54 (MSQOL-54)(From baseline to the end of the intervention at 8 weeks)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zelal Apaydın

Principal Investigator

Istanbul University - Cerrahpasa

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