Spinal Cord InjuriesNCT05904600
Respiratory Muscle Training in Adults With Spinal Cord Injury
A study testing Respiratory muscle training in people with Spinal Cord Injuries, run by University of Castilla-La Mancha at 1 site in Spain.
Trial 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 (C4-T6) in acute phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Respiratory muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 30 Aug 2022to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 C4 and T6 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Combined Inspiratory and Expiratory Muscle Training in People With Spinal Cord Injury: an Exploratory Randomized Clinical Trial
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 (C4-T6) in acute phase.
Read the 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.).
Deviation from protocol: The initial recruitment estimates were overly optimistic. The planned sample size was 112 participants, including 56 with cervical spinal cord injury and 56 with thoracic spinal cord injury. However, the actual recruitment rate was lower than anticipated, making it unfeasible to achieve the target sample size within the planned study period. As the study was conducted at a single centre, the pool of eligible participants was limited. Furthermore, extending the recruitment period further threatened the continuity and stability of the research team. Therefore, the study was redefined as an exploratory study, and this change is reflected in the revised title and the analytical approach.
- Conditions
- Spinal Cord Injuries
- Being tested
- Respiratory muscle training, Control group
- Keywords
- Spinal Cord Injuries, Breathing exercises, Respiratory muscle training
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory muscle trainingDevice
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 groupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory muscle training | Experimental | 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. Receives: Device: Respiratory muscle training |
| Control group | Sham comparator | Simulated training with the Orygen-Dual Valve (Forumed S.L. ESP), without load. Receives: Device: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change 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.
Measured: 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.
Measured: Change after 6 weeks of intervention compared to baseline
Secondary outcomes (8)
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.
Measured: 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).
Measured: Change after 6 weeks of intervention compared to baseline
Change in elbow flexion strength
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Change after 6 weeks of intervention compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start30 Aug 2022
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo
- Responsible party
- Sponsor
- Investigators
- Ana Torres-Costoso, Principal investigator, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904600
- Sponsor's protocol ID
- FFEHNP
- Status last verified
- Apr 2026
- First submitted
- 11 May 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the research team, and the health authorities, who have a duty of confidentiality, will have access to all data collected by the study. Information that cannot be identified may be passed on to third parties.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Inspiratory and Expiratory Muscle Training in People With Spinal Cord Injury: an Exploratory Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05904600
- Acronym / sponsor ID
- FFEHNP
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injuries, Breathing exercises, Respiratory muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (C4-T6) 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.).
Deviation from protocol: The initial recruitment estimates were overly optimistic. The planned sample size was 112 participants, including 56 with cervical spinal cord injury and 56 with thoracic spinal cord injury. However, the actual recruitment rate was lower than anticipated, making it unfeasible to achieve the target sample size within the planned study period. As the study was conducted at a single centre, the pool of eligible participants was limited. Furthermore, extending the recruitment period further threatened the continuity and stability of the research team. Therefore, the study was redefined as an exploratory study, and this change is reflected in the revised title and the analytical approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respiratory muscle training | Experimental | Device: Respiratory muscle trainingRespiratory muscle training with the Orygen-Dual Valve (Forumed S.L. ESP) and an initial load of 30% of their maximum inspiratory and expiratory pressures. |
| Control group | Sham comparator | Device: Control groupSimulated training with the Orygen-Dual Valve (Forumed S.L. ESP), without load. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 C4 and T6 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory muscle trainingThe 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 | Respiratory muscle training |
| Control groupIn 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. | Device | Control group |
Primary outcome
Change in maximal expiratory pressure
Time frame: Change after 6 weeks of intervention compared to baseline
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.
Change in maximal inspiratory pressure
Time frame: Change after 6 weeks of intervention compared to baseline
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.
8 secondary outcomes
Change in forced vital capacity (FVC)
Time frame: Change after 6 weeks of intervention compared to baseline
Change in coughing capacity
Time frame: Change after 6 weeks of intervention compared to baseline
Change in elbow flexion strength
Time frame: Change after 6 weeks of intervention compared to baseline
Change in shoulder flexion strength
Time frame: Change after 6 weeks of intervention compared to baseline
Change in number of people with respiratory complications
Time frame: Change after 6 weeks of intervention compared to baseline
Change in health-related quality of life assessed by Short-Form 36 questionnaire.
Time frame: Change after 6 weeks of intervention compared to baseline
Change in forced expiratory volume in the first second (FEV1)
Time frame: Change after 6 weeks of intervention compared to baseline
Change in cardiorespiratory fitness
Time frame: Change after 6 weeks of intervention compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No. Only the research team, and the health authorities, who have a duty of confidentiality, will have access to all data collected by the study. Information that cannot be identified may be passed on to third parties.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Torres-Costoso principal investigator
University of Castilla-La Mancha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory muscle training in people with Spinal Cord Injuries, run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximal expiratory pressure (time frame: Change after 6 weeks of intervention compared to baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.