Inspiratory Muscle Training in Individuals With Multiple Sclerosis

NCT07672535 | Not Yet Recruiting

• 1 other identifier: ZApaydın-1
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Sclerosis; Inspiratory Muscle Training

Keywords

multiple sclerosis; inspiratory muscle training; respiratory muscle training; respiratory muscle strength

Outcome Measures

Primary Outcomes (7)

• Maximal inspiratory pressure (MIP)

  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.

  From baseline to the end of the intervention at 8 weeks

• Maximal expiratory pressure (MEP)

  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.

  From baseline to the end of the intervention at 8 weeks

• Forced Vital Capacity (FVC)

  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.

  From baseline to the end of the intervention at 8 weeks

• Forced Expiratory Volume (FEV1)

  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.

  From baseline to the end of the intervention at 8 weeks

• Tiffeneau Index (FEV1/FVC)

  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.

  From baseline to the end of the intervention at 8 weeks

• Peak Expiratory Flow (PEF)

  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.

  From baseline to the end of the intervention at 8 weeks

• Cough strength

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

  From baseline to the end of the intervention at 8 weeks

Secondary Outcomes (8)

• 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

• 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

Study Arms (3)

High intensity interval IMT group

EXPERIMENTAL

High-intensity interval IMT and conventional rehabilitation

Behavioral: High intensity interval IMT

Low intensity IMT group

EXPERIMENTAL

Low intensity IMT and conventional rehabilitation

Behavioral: Low intensity IMT

Conventional rehabilitation

ACTIVE COMPARATOR

Conventional rehabilitation

Behavioral: Conventional rehabilitation

Interventions

High intensity interval IMT BEHAVIORAL

Participants with multiple sclerosis (MS) in this group will perform high intensity interval inspiratory muscle training (IMT) for 8 weeks, three times per week (one supervised by a physiotherapist and two home-based sessions). The protocol consists of 7 cycles of 2 minutes of exercise followed by 1 minute of rest, with each session lasting 21 minutes. Training intensity will start at 30% of maximal inspiratory pressure (MIP) and progressively increase to 70% by the third week. From week 4 onward, intensity will be maintained at 70% of MIP and adjusted according to tolerance, based on a Borg scale rating of 3-5. In addition, participants in this group will receive a conventional rehabilitation program for 8 weeks, consisting of three sessions per week: one supervised session conducted by a physiotherapist and two supervised home-based sessions.

High intensity interval IMT group

Low intensity IMT BEHAVIORAL

Participants with multiple sclerosis (MS) in this group will perform low intensity inspiratory muscle training (IMT) for 8 weeks, consisting of five sessions per week: one supervised by a physiotherapist and four home-based supervised sessions. The training will be performed as two daily sessions of 15 minutes each, totaling 30 minutes per day. Low intensity IMT will be conducted at 30% of maximal inspiratory pressure (MIP). Training intensity will be reassessed and adjusted to 30% of MIP every two weeks during supervised sessions, based on repeated MIP measurements. During training, participants will be instructed to maintain a seated position with the upper chest and shoulders in a relaxed posture. In addition, participants in this group will receive a conventional rehabilitation program for 8 weeks, consisting of three sessions per week: one supervised session conducted by a physiotherapist and two supervised home-based sessions.

Low intensity IMT group

Conventional rehabilitation BEHAVIORAL

Participants in this group will undergo a conventional rehabilitation program for 8 weeks, consisting of three sessions per week: one supervised by a physiotherapist and two home-based supervised sessions. Each session will last approximately 40 minutes. The program will include warm-up exercises, aerobic exercises, strengthening exercises, balance exercises, and cool-down exercises.

Conventional rehabilitation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 20, 2026
• First Posted: June 29, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share