Multiple Sclerosis
Conditions
Keywords
multiple sclerosis, Muscle Strength, Patient Outcome Assessment, Maximal Respiratory Pressures
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.
Interventions
OTHERRespiratory 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.
OTHERRespiratory 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.
Sponsors
Tamara del Corral Núñez-Flores
Colegio de Fisioterapeutas de la Comunidad de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory muscle strength | Pre -intervention and at the end of the respiratory muscle training (8 weeks) | Maximal inspiratory preassure and Maximal expiratory preassure |
| Inspiratory muscle endurance | 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
| Measure | Time frame | Description |
|---|---|---|
| Health related quality of life | 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. |
| Fatigue | 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. |
| Fragility | 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. |
| Degree of disability | 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. |
Countries
Spain
Outcome results
None listed