NCT05904600

Respiratory Muscle Training in Adults With Spinal Cord Injury

Respiratory Muscle Training to Improve Functional Capacity and Prevent Respiratory Complications in Adults With Spinal Cord Injury

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: University of Castilla-La Mancha · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.).

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2022-08-30
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2023-06-15
• Last updated: 2023-06-15

Locations

1 site across 1 country: Spain