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

NCT07269054 | Not Yet Recruiting

• 1 other identifier: 24/119-E_BC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; Muscle Strength; Patient Outcome Assessment; Maximal Respiratory Pressures

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Health related quality of life

  Pre -intervention and at the end of the respiratory muscle training (8 weeks)

• Fatigue

  Pre -intervention and at the end of the respiratory muscle training (8 weeks)

• Fragility

  Pre -intervention and at the end of the respiratory muscle training (8 weeks)

• Degree of disability

  Pre -intervention and at the end of the respiratory muscle training (8 weeks)

Study Arms (2)

Respiratory muscle training + 1-repetition maximum test

EXPERIMENTAL

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

Respiratory muscle training + reference test

ACTIVE COMPARATOR

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

Interventions

Respiratory muscle training + reference test OTHER

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.

Respiratory muscle training + reference test

Respiratory muscle training + 1-repetition maximum test OTHER

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.

Respiratory muscle training + 1-repetition maximum test

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Asociación Mostoleña de Esclerosis Múltiple

Móstoles, Madrid, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Central Study Contacts

Tamara del Corral Núñez-Flores del Corral Núñez-Flores, PhD

CONTACT

+34 91 394 1517; tamdelco@ucm.es

Ibai López de Uralde Villanueva Ibai López de Uralde Villanueva, PhD, PhD

CONTACT

+34 91 394 1517; ibai.lope@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Tenure-track professor with a PhD in the Department of Physiotherapy

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 8, 2025
• Study Start: December 15, 2025
• Primary Completion: December 15, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)