Respiratory Muscle Training Program in Patients With Multiple Sclerosis

NCT06405451 | Completed

• 1 other identifier: 23/685-E
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This is a quasi-experimental pre-post trial aimed at investigating the effects of respiratory muscle training (RMT) as trunk stabilization exercise in patients diagnosed with multiple sclerosis (MS)

Conditions

Multiple Sclerosis; Respiration Disorders

Keywords

multiple sclerosis; treatment; trunk disorder; balance; respiratory function

Outcome Measures

Primary Outcomes (6)

• Pulmonary function

  Spirometric functional testing will be conducted according to SEPAR Regulation (2013). Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) will be measured using a pneumotachograph or open system spirometer. Participants' birth date and height will be recorded to compare with population averages. They will sit upright in a chair, wearing loose clothing, with a nasal clip to prevent leaks. Instructions will be given to exhale fully, then inhale deeply, hold briefly, and exhale forcefully. The researcher will correct any errors. Acceptable maneuvers must start quickly, have steady exhalation, and last at least 6 seconds. Three to eight maneuvers will be performed, and the best FVC and FEV1 values will be recorded.

  2 months

• Respiratory muscle strength

  Respiratory muscle strength is assessed using maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP). After measuring FVC and FEV1, participants will rest for 5 minutes before the next maneuver. MEP will be performed first, followed by MIP. Each maneuver will be repeated 6 times with 1 minute of rest in between. The highest MIP and MEP values, measured in cm3 of H2O, will be compared with population norms.

  2 months

• Abdominal and diaphragmatic muscle structure

  Ultrasound measurements of the abdominal wall and diaphragm will be conducted by an expert using the LOGIQ S7 Expert ultrasound system. To ensure accuracy and compliance with RUSI regulations, three measurements will be taken for each parameter, then averaged. 1. Diaphragm Ultrasound: Thickness and excursion during inspiration will be evaluated. Measurements will be taken in the right hemidiaphragm using a 10-12MHz linear probe, perpendicular to the intercostal space. Diaphragm thickness below 2mm is considered atrophy. Diaphragm excursion will be measured using a 2.5 to 3.5 MHz convex probe during tidal and forced inspirations. 2. Abdominal Musculature Ultrasound: Muscle layers and abdominal diastasis will be assessed. Abdominal diastasis will be measured with the participant lying supine, knees bent at 90º, and arms along the body. Muscle thickness will be measured at the navel level. Measurements will be taken at quiet and forced expiration.

  2 months

• Trunk control

  Measured with the TIS Scale. The aim of this scale is to measure the static and dynamic stability of the trunk in sitting position without back support. It consists of 17 items and is scored according to the validated rubric. A higher score indicates better balance, with the highest possible score being 23 points. This scale is validated for patients with multiple sclerosis. This scale will only be administered to those MS patients who are able to walk.

  2 months

• Balance

  It will be measured with the BERG scale. This test is used to assess balance through functional abilities in standing position. It consists of 14 items to be rated from 0 to 4 (higher scores indicate better balance), with a total score of 56. This scale will only be administered to those MS patients who are able to walk.

  2 months

• Gait and transfer capacity

  It will be measured with the Timed Up and Go test (TUG). The objective of this test is to assess activity limitations proposed by the ICF by examining the patient's ability to walk and perform transfers. The test involves rising from a chair, walking ten meters along an indoor flat corridor, turning 180º, and returning to sit back in the same chair, using the usual assistive device. The result of the test will be the total time taken from the command until the second sitting. This scale will only be administered to those MS patients who are able to walk.

  2 months

Secondary Outcomes (1)

• Therapeutic adherence

  2 months

Study Arms (2)

Conventional treatment

ACTIVE COMPARATOR

Conventional treatment to improve trunk control and stability for 30 minutes, twice a day, six times a week.

Other: Conventional treatment

Experimental treatment

EXPERIMENTAL

Respiratory muscle training will be conducted using the Threshold IMT-Philips inspiratory training device and the Threshold PEP expiratory training device, both from Respironics®. Participants will be comfortably seated in a chair with their feet on the ground, without back support, and with the trunk at a 90° angle to the hips. A conventional nasal clip will be used to prevent air leaks. During forced expiratory training, participants will use the ThresholdPEP® with a customized mouthpiece and perform forced expiration through the resistance device. Inspiratory muscle training will follow the same procedure using the Threshold IMT®. Both inspiratory and expiratory training will be repeated 10-15 times, 5 sets for 20 minutes in one session, with a rest time of 30-60 seconds between each set.

Other: Conventional treatment; Other: Experimental treatment

Interventions

Conventional treatment OTHER

Conventional treatment to improve trunk control and stability for 30 minutes, twice a day, and six times per week.

Conventional treatment; Experimental treatment

Experimental treatment OTHER

Respiratory muscle training will be conducted using the Threshold IMT-Philips inspiratory training device and the Threshold PEP expiratory training device, both from Respironics®. Participants will be comfortably seated in a chair with their feet on the ground, without back support, and with the trunk at a 90° angle to the hips. A conventional nasal clip will be used to prevent air leaks. During forced expiratory training, participants will use the ThresholdPEP® with a customized mouthpiece and perform forced expiration through the resistance device. Inspiratory muscle training will follow the same procedure using the Threshold IMT® (45). Both inspiratory and expiratory trainings will be repeated 10-15 times, 5 sets for 20 minutes in one session, with a rest time of 30-60 seconds between each set.

Experimental treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of Multiple Sclerosis based on McDonald criteria, with a disease duration of more than two years (relapsing or progressive) (McDonald et al., 2001).
• All multiple sclerosis patients are included according to the Kurtzke Disability Status Scale (EDSS) ANEX II (Kurtzke 1983, Tollár 2020).\*
• Stable medical treatment for at least the six months prior to the intervention (Tollár, 2020).
• Absence of cognitive impairment, with the ability to understand instructions and achieve a score equal to or greater than 24 on the Mini-Mental State Examination (Folstein, Folstein \& McHugh, 1975, Tollár 2020).

You may not qualify if:

• Diagnosis of another neurological disease or musculoskeletal alteration other than MS.
• Diagnosis of any cardiovascular, respiratory, or metabolic disease, or other conditions that may interfere with this study.
• Experienced exacerbation or hospitalization within the last 3 months prior to initiating the assessment protocol, nor during the therapeutic intervention process.
• Received a cycle of steroids, intravenously or orally, 6 months prior to the start of the assessment protocol and within the study intervention period.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead
• Fundación Madrid contra la Esclerosis Múltiple (FEMM): collaborator
• Sanitas: collaborator

Study Sites (1)

Universidad Europea de Madrid

Villaviciosa de Odón, Madrid, 28670, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis; Respiration Disorders; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding will involve the evaluators, who will be unaware of which intervention group each subject belongs to
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a quasi-experimental pre-post trial. The research will be conducted in accordance with the Helsinki Declaration and the Personal Data Protection and Guarantee of Digital Rights Act (Organic Law 3/2018). The design of this project will adhere to the standard protocol elements of a clinical trial: SPIRIT statement.

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: May 8, 2024
• Study Start: April 9, 2024
• Primary Completion: July 1, 2024
• Study Completion: December 31, 2024
• Last Updated: June 10, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)