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

NCT ID: NCT07269054

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2026-06-01

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.

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Respiratory muscle training + 1-repetition maximum test

Intervention Type: 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 + 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.

Group Type: ACTIVE_COMPARATOR

Respiratory muscle training + reference test

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ilustre Colegio Oficial de Fisioterapeutas de la Comunidad de Madrid

UNKNOWN

Sponsor Role: collaborator

Tamara del Corral Núñez-Flores

OTHER

Sponsor Role: lead

Responsible Party

Tamara del Corral Núñez-Flores

Tenure-track professor with a PhD in the Department of Physiotherapy

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Asociación Mostoleña de Esclerosis Múltiple

Móstoles, Madrid, Spain

Countries

Spain

Central Contacts

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

Role: CONTACT

tamdelco@ucm.es

+34 91 394 1517

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

Role: CONTACT

ibai.lope@ucm.es

+34 91 394 1517 ext. 1517

Facility Contacts

Vanesa Mellado Rubio

Role: primary

asociacion@amdem.org

0034 91 664 38 80

Other Identifiers

24/119-E_BC

Identifier Type: -

Identifier Source: org_study_id