Effects of Home-based Respiratory Muscle Training With New Load Adjustment Test in People With Multiple Sclerosis

Validation of the New Protocol Based on the Principles of the 1-repetition Maximum Test for Evaluating Maximum Respiratory Pressures in Individuals With Multiple Sclerosis.

The main objective of the present study is to verify whether respiratory muscle training programme (IMT+EMT; included both inspriratory and expiratory muscles with load adjustment based on the principles of the 1-repetition maximum (RM) test), applied by telerehabilitation, is an effective intervention (versus a respiratory muscle training programme (IMT+EMT; included both inspriratory and expiratory muscles with convetional load adjustment) in improving fragility, quality of life and physical function in people with Multiple Sclerosis.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Respiratory muscle training + 1-repetition maximum test; Other: Respiratory muscle training + reference test

Detailed Description

It is a single-blind randomized clinical trial study. Each participant will be randomly assigned to one of the following groups: 1) Inspiratory muscle training + Expiratory muscle training with load adjustment based on the principles of the 1-repetition maximum (RM) test , 2) Inspiratory muscle training + Expiratory muscle training with convetional load adjustment.

Each exercise training program will be applied twice (morning inspiratory muscle training session and evening expiratory muscle training session) per day 5 sessions per week during 8 weeks by a threshold device. The sessions will be supervised by a physiotherapist through a virtual platform.

Participants received baseline assessments at the beginning of the intervention, at the end of the 4th week (only the group 2), and post-intervention assessments at the end of the 8th week.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tamara del Corral Núñez-Flores del Corral Núñez-Flores, PhD; Phone Number: +34 91 394 1517; Email: tamdelco@ucm.es
• Study Contact Backup: Name: Ibai López de Uralde Villanueva Ibai López de Uralde Villanueva, PhD, PhD; Phone Number: 1517 +34 91 394 1517; Email: ibai.lope@ucm.es

Study Locations

• Spain
  • Madrid
    • Móstoles, Madrid, Spain
      • Asociación Mostoleña de Esclerosis Múltiple
      • Contact: Vanesa Mellado Rubio; Phone Number: 0034 91 664 38 80; Email: asociacion@amdem.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Presence of Multiple Sclerosis disease
• Age 18 years or older
• Clinical stability

Exclusion Criteria:

• Any condition that contraindicate respiratory muscle training
• Inability to close the lips to hold the training device's mouthpiece (e.g., facial paralysis)
• Pregnancy
• Inability to adhere to remote monitoring

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Respiratory muscle training + 1-repetition maximum test; Participants will perform an inspiratory and expiratory muscle training program by a threshold device at home, twice a day (morning inspiratory muscle training session and evening expiratory muscle training session) for 8 weeks supervised by a physiotherapist through a virtual platform. The load adjustment will be based on the principles of the 1-repetition maximum (RM) test.	Other: Respiratory muscle training + 1-repetition maximum test; Participants will engage in respiratory muscle training programme at home using a respiratory muscle training threshold device . This training will be conducted twice daily, five days a week, for eight weeks, with physiotherapist supervision provided by telerehabilitation. The load adjustment will be based on the principles of the 1-repetition maximum (RM) test.
Active Comparator: Respiratory muscle training + reference test; Participants will perform an inspiratory and expiratory muscle training program by a threshold device at home, twice a day (morning inspiratory muscle training session and evening expiratory muscle training session) for 8 weeks supervised by a physiotherapist through a virtual platform. The load adjustment will be based on the conventional test to be performed during the 4th week.	Other: Respiratory muscle training + reference test; Participants will perform an inspiratory and expiratory muscle training program by a threshold device at home, twice a day (morning inspiratory muscle training session and evening expiratory muscle training session) for 8 weeks supervised by a physiotherapist through a virtual platform. The load adjustment will be based on the conventional test to be performed during the 4th week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory muscle strength	Maximal inspiratory preassure and Maximal expiratory preassure	Pre -intervention and at the end of the respiratory muscle training (8 weeks)
Inspiratory muscle endurance	Inspiratory muscle endurance will be assed by an incremental load test that required subjects to breathe against inspiratory threshold loads that were increased each minute by 10% of baseline PI,max until voluntary task failure muscle endurance test. Inspiratory muscle endurance was defined as the PI,max sustained for a minimum of 1 min.	Pre -intervention and at the end of the respiratory muscle training (8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life	To evaluate the health-related quality of life of the participants a valid, reliable and generic questionnaire will be used. EuroQol-five-dimensional Questionnaire a numerical value represented Health state as EQ-5D 'index values' or 'index scores' reflecting how good or bad a health state is. It consisted of five dimensions (Mobility, Self-care, Usual activities, Pain & discomfort, Anxiety & depression), each of which has five severity levels that are described by statements appropriate to that dimension.	Pre -intervention and at the end of the respiratory muscle training (8 weeks)
Fatigue	Modified Fatigue Impact Scale (MFIS). The MFIS is a valid and reliable instrument for assessing fatigue severity. It consists in 21 items. Higher scores mean a worse fatigue.	Pre -intervention and at the end of the respiratory muscle training (8 weeks)
Fragility	Frailty indexes (FI) and the Comprehensive GeriatricAssessment (CGA) are multidimensional tools. FI serve to quantitatively measure frailty levels. They have shown to have an excellent correlation with mortality.	Pre -intervention and at the end of the respiratory muscle training (8 weeks)
Degree of disability	The Barthel index (BI) is a 10-item activities of daily living ordinal scale used primarily for disability measurement. The values assigned to each item are based on the time and amount of physical assistance required for a patient to perform a common daily activity.	Pre -intervention and at the end of the respiratory muscle training (8 weeks)

Collaborators and Investigators

• Sponsor: Tamara del Corral Núñez-Flores
• Collaborators: Ilustre Colegio Oficial de Fisioterapeutas de la Comunidad de Madrid

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2025
• Primary Completion (Estimated): December 15, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: multiple sclerosis; Muscle Strength; Patient Outcome Assessment; Maximal Respiratory Pressures
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Therapeutics; Mind-Body Therapies; Complementary Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Breathing Exercises
• Other Study ID Numbers: 24/119-E_BC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No