NCT07269054

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tamara del Corral Núñez-Flores · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2025-12-15
• Primary completion: 2025-12-15
• Completion: 2026-06-01
• First posted: 2025-12-08
• Last updated: 2025-12-08

Locations

1 site across 1 country: Spain