Clinical trial NCT05904600: Respiratory Muscle Training in Adults With Spinal Cord Injury
Official title: Respiratory Muscle Training to Improve Functional Capacity and Prevent Respiratory Complications in Adults With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Spinal Cord Injuries
Breathing exercises
Respiratory muscle training
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
Collaborators: name: Hospital Nacional de Parapléjicos de Toledo
First posted: 2023-06-15
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in maximal expiratory pressure
timeFrame: Change after 6 weeks of intervention compared to baseline
measure: Change in maximal inspiratory pressure
timeFrame: Change after 6 weeks of intervention compared to baseline
Secondary outcomes:
measure: Change in forced vital capacity (FVC)
timeFrame: Change after 6 weeks of intervention compared to baseline
measure: Change in coughing capacity
timeFrame: Change after 6 weeks of intervention compared to baseline
measure: Change in elbow flexion strength
timeFrame: Change after 6 weeks of intervention compared to baseline
measure: Change in shoulder flexion strength
timeFrame: Change after 6 weeks of intervention compared to baseline
measure: Change in number of people with respiratory complications
timeFrame: Change after 6 weeks of intervention compared to baseline
measure: Change in health-related quality of life assessed by Short-Form 36 questionnaire.
timeFrame: Change after 6 weeks of intervention compared to baseline
measure: Change in forced expiratory volume in the first second (FEV1)
timeFrame: Change after 6 weeks of intervention compared to baseline
measure: Change in cardiorespiratory fitness
timeFrame: Change after 6 weeks of intervention compared to baseline
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Sara Reina Gutiérrez
Study officials:
affiliation: University of Castilla-La Mancha
name: Ana Torres-Costoso
role: PRINCIPAL_INVESTIGATOR
References: