Respiratory Muscle Training in Adults With Spinal Cord Injury

University of Castilla-La Mancha

Status: Enrolling

Conditions: Spinal Cord Injuries

Treatments: Device: Respiratory muscle training; Device: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT05904600

FFEHNP

Details and patient eligibility

About

The purpose of this study is to investigate the effectiveness of a programme based on inspiratory and expiratory muscle training to improve respiratory muscle strength, functional capacity and avoid pulmonary complications in adults with cervical or high dorsal spinal cord injury (C5-D5) in acute phase.

Full description

The design of the study is a randomised, triple-blind clinical trial with a control group.

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.).

Enrollment: 112 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• People diagnosed with spinal cord injury.
• 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

• People with chest trauma.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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112 participants in 2 patient groups

Respiratory muscle training

Experimental group

Description:

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.

Treatment:

Device: Respiratory muscle training

Control group

Sham Comparator group

Description:

Simulated training with the Orygen-Dual Valve (Forumed S.L. ESP), without load.

Treatment:

Device: Control group