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Completed

NCT Number: NCT07269054

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asociación Mostoleña de Esclerosis Múltiple

Móstoles, Madrid, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 + 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.

Primary outcomes

  1. Respiratory muscle strength

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

    Maximal inspiratory preassure and Maximal expiratory preassure

  2. Inspiratory muscle endurance

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

    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.

Secondary outcomes

  1. Health related quality of life

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

    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.

  2. Fatigue

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

    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.

  3. Fragility

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

    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.

  4. Degree of disability

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

    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.

Sponsors and collaborators

Lead sponsor

Tamara del Corral Núñez-Flores

Other

Collaborators

  • Colegio de Fisioterapeutas de la Comunidad de Madrid

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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