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

Tamara del Corral Núñez-Flores

Status: Not yet enrolling

Conditions: Multiple Sclerosis

Treatments: Other: Respiratory muscle training + 1-repetition maximum test; Other: Respiratory muscle training + reference test

Study type: Interventional

Funder types: Other

Identifiers

NCT07269054

24/119-E_BC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Respiratory muscle training + 1-repetition maximum test

Experimental group

Description:

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.

Treatment:

Other: Respiratory muscle training + 1-repetition maximum test

Respiratory muscle training + reference test

Active Comparator group

Description:

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.

Treatment:

Other: Respiratory muscle training + reference test