Respiratory Muscle Training in Adults With Spinal Cord Injury
NCT ID: NCT05904600
Last Updated: 2023-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
112 participants
INTERVENTIONAL
2022-08-30
2023-12-30
Brief Summary
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Detailed Description
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The size of the sample will be 56 participants with cervical spinal cord injury and 56 with dorsal spinal cord injury. They will be randomized in two groups: experimental or control. The experimental group will perform combined inspiratory and expiratory muscle training as part of their rehabilitation programme during 6 weeks. The control group will continue their usual treatment.
Measurements will be taken at baseline, and post-intervention.
The statistical analysis will be an intention-to-treat analysis, and the data processing and analysis will be carried out with the Statistical Package for the Social Sciences (SPSS) version 24.0 for Windows (Armonk, NY: IBM Corp.).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Masking of the participants: the control group will have a training of the respiratory muscles simulated with the same device as the intervention group. They will use the device without load and with an opaque adhesive tape surrounding the device to mask the valve position.
Study Groups
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Respiratory muscle training
Respiratory muscle training with the Orygen-Dual Valve (Forumed S.L. ESP) and an initial load of 30% of their maximum inspiratory and expiratory pressures.
Respiratory muscle training
The training of the intervention group will have an initial workload of 30% of maximal inspiratory and expiratory pressures, which will be increased weekly by 10% according to tolerance, if not tolerated by 5%. In addition, patients will be instructed to maintain a normal respiratory rate (12-16 breaths per minute). Moreover, they will continue their usual treatment.
Control group
Simulated training with the Orygen-Dual Valve (Forumed S.L. ESP), without load.
Control group
In the control group, the respiratory muscle training will be simulated by using the device without load throughout the study period using an opaque adhesive tape surrounding the device to mask the valve position.
Interventions
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Respiratory muscle training
The training of the intervention group will have an initial workload of 30% of maximal inspiratory and expiratory pressures, which will be increased weekly by 10% according to tolerance, if not tolerated by 5%. In addition, patients will be instructed to maintain a normal respiratory rate (12-16 breaths per minute). Moreover, they will continue their usual treatment.
Control group
In the control group, the respiratory muscle training will be simulated by using the device without load throughout the study period using an opaque adhesive tape surrounding the device to mask the valve position.
Eligibility Criteria
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Inclusion Criteria
* Over 18 years of age.
* Time of evolution less than 6 months and at least 4 weeks after the date of injury.
* Level of lesion between C5 and D5 and degree of involvement A or B. In case of involvement A with partial preservation zone this should not include abdominal musculature according to the international standardised classification of the American Spinal Injury Association.
Exclusion Criteria
* Mechanically ventilated.
* Pregnant women.
* Any medical or psychiatric condition that could affect the ability to complete the study.
* Carrying a tracheostomy tube that does not tolerate occlusion.
* People who can not sit upright.
18 Years
ALL
No
Sponsors
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Hospital Nacional de Parapléjicos de Toledo
OTHER
University of Castilla-La Mancha
OTHER
Responsible Party
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Principal Investigators
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Ana Torres-Costoso
Role: PRINCIPAL_INVESTIGATOR
University of Castilla-La Mancha
Locations
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Sara Reina Gutiérrez
Toledo, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FFEHNP
Identifier Type: -
Identifier Source: org_study_id
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