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| Name | Class |
|---|---|
| Colegio de Fisioterapeutas de la Comunidad de Madrid | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asociación Mostoleña de Esclerosis Múltiple | Móstoles | Madrid | Spain |
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| 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. |
|
| Pre -intervention and at the end of the respiratory muscle training (8 weeks) |
| Fatigue | 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. | Pre -intervention and at the end of the respiratory muscle training (8 weeks) |
| Fragility | 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. | Pre -intervention and at the end of the respiratory muscle training (8 weeks) |
| Degree of disability | 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. | Pre -intervention and at the end of the respiratory muscle training (8 weeks) |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
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