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.
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.).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
112
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.
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.
Sara Reina Gutiérrez
Toledo, Spain
RECRUITINGChange in maximal expiratory pressure
The measurement of maximum static respiratory pressures will consist of performing maximum forced inspiration and expiration manoeuvres against an occluded airway in order to measure the pressure generated in the mouth, using a manometer or a pressure transducer, since, with the glottis open, the pressure in the mouth must be equal to the alveolar pressure.
Time frame: Change after 6 weeks of intervention compared to baseline
Change in maximal inspiratory pressure
The measurement of maximum static respiratory pressures will consist of performing maximum forced inspiration and expiration manoeuvres against an occluded airway in order to measure the pressure generated in the mouth, using a manometer or a pressure transducer, since, with the glottis open, the pressure in the mouth must be equal to the alveolar pressure.
Time frame: Change after 6 weeks of intervention compared to baseline
Change in forced vital capacity (FVC)
Using a spirometer, with the mouthpiece tightly sealed around the lips, the participant is asked, from the residual volume, to perform a rapid but unforced maximal inspiratory manoeuvre. With an apnoea of less than one second at total lung capacity, the participant is asked to exhale maximally, rapidly and forcibly, until the lungs are completely empty. At this point, the participant is strongly encouraged to start the manoeuvre abruptly and to prolong the exhalation long enough to reach RV.
Time frame: Change after 6 weeks of intervention compared to baseline
Change in coughing capacity
Measurement of cough capacity will be performed by determining peak cough flow using a peak expiratory flow meter (Mini Wright flow meter; Clement Clarke International Ltd., Essex, UK).
Time frame: Change after 6 weeks of intervention compared to baseline
Change in elbow flexion strength
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In all subjects, the maximum load they can move in one repetition (1RM) in both limbs will be assessed for elbow flexion with Microfet4 dynamometer; Hoggan Health Industries, West Jordan, Utah.
Time frame: Change after 6 weeks of intervention compared to baseline
Change in shoulder flexion strength
In all subjects, the maximum load they can move in one repetition (1RM) in both limbs will be assessed for shoulder flexion with Microfet4 dynamometer; Hoggan Health Industries, West Jordan, Utah.
Time frame: Change after 6 weeks of intervention compared to baseline
Change in number of people with respiratory complications
Respiratory complications will be assessed by consulting the medical history.
Time frame: Change after 6 weeks of intervention compared to baseline
Change in health-related quality of life assessed by Short-Form 36 questionnaire.
Health-related quality of life will be measured with the Short-Form 36 questionnaire, with values ranging from 0 to 100 (higher scores mean better health-related quality of life).
Time frame: Change after 6 weeks of intervention compared to baseline
Change in forced expiratory volume in the first second (FEV1)
Using a spirometer, with the mouthpiece tightly sealed around the lips, the participant is asked, from the residual volume, to perform a rapid but unforced maximal inspiratory manoeuvre. With an apnoea of less than one second at total lung capacity, the participant is asked to exhale maximally, rapidly and forcibly, until the lungs are completely empty. At this point, the participant is strongly encouraged to start the manoeuvre abruptly and to prolong the exhalation long enough to reach RV.
Time frame: Change after 6 weeks of intervention compared to baseline
Change in cardiorespiratory fitness
Cardiorespiratory fitness will be measured using the 6-minute wheelchair propulsion test (adapted from Bass A et al. 2020). This is a validated test to measure cardiorespiratory fitness through a submaximal exercise test where the patient performs a 25-metre figure-eight run for 6 minutes and the distance covered in that time is recorded.
Time frame: Change after 6 weeks of intervention compared to baseline