Spinal Cord Injury (SCI), Respiratory ComplicationNCT06547606
Effect of Resistive Inspiratory Muscle Training Optimizing Lung Function in Spinal Cord Injury
A study of Spinal Cord Injury (SCI), Respiratory Complication, run by University of Dhaka.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of resistive inspiratory muscle training (RIMT) in optimizing lung function in individuals with spinal cord injury (SCI). It will also learn about the safety and impact of RIMT on health-related quality of life in this population. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury (SCI), Respiratory Complication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Jan 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People with Traumatic Cervical Cord Injury
- Impaired respiratory function
Who cannot join
- Participants who have Progressive diseases, Head injury, A psychiatric condition , Medical instability, Ventilator dependency, and Presence of tracheostomy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Resistive Inspiratory Muscle Training on Optimizing Lung Function in Individuals With Spinal Cord Injury
The goal of this clinical trial is to evaluate the effectiveness of resistive inspiratory muscle training (RIMT) in optimizing lung function in individuals with spinal cord injury (SCI). It will also learn about the safety and impact of RIMT on health-related quality of life in this population. The main questions it aims to answer are:
Does RIMT improve respiratory function in individuals with SCI? What impact does RIMT have on the health-related quality of life of participants? What are the perceived exertion or dyspnoea levels in participants undergoing RIMT? Researchers will compare RIMT to conventional respiratory physiotherapy to see if RIMT works to enhance lung function and improve overall respiratory outcomes in individuals with SCI.
Read more
Participants will:
Perform resistive inspiratory muscle training along with conventional respiratory physiotherapy 5 days a week for 4 weeks.
Read the detailed description
Globally, over 15 million people are living with spinal cord injury (SCI), according to the World Health Organization (WHO) in 2024. SCI disrupts the normal functioning of the spinal cord, leading to significant physical and neurological impairments. One of the major challenges in SCI management is respiratory complications, which contribute significantly to morbidity and mortality. Resistive inspiratory muscle training (RIMT) has emerged as a promising intervention to enhance respiratory muscle strength and function, potentially reducing respiratory complications in SCI.
The primary objective of this clinical trial is to evaluate the effectiveness of RIMT in optimizing lung function in individuals with SCI. The study also aims to assess the safety of RIMT and its impact on the health-related quality of life of participants.
Researchers will compare RIMT to conventional respiratory physiotherapy to see if RIMT works to enhance lung function and improve overall respiratory outcomes in individuals with SCI.
The study population will consist of individuals with cervical spinal cord injury (SCI) who have impaired respiratory function and are admitted for inpatient rehabilitation. The inclusion criteria include individuals aged 18 to 65 years with cervical cord injury and impaired respiratory function. Exclusion criteria include progressive diseases, head injury, psychiatric conditions, medical instability, ventilator dependency, and the presence of a tracheostomy.
The clinical trial will be conducted at the Spinal Cord Injury Unit of the Centre for the Rehabilitation of the Paralyzed (CRP) in Savar, Dhaka. The CRP provides comprehensive rehabilitation services to patients from all over Bangladesh, ensuring that the study population reflects a broad demographic and economic spectrum.
This study is designed as a randomized controlled trial (RCT) with participants randomly allocated to either the intervention group or the control group. The intervention group will receive resistive inspiratory muscle training (RIMT) in addition to conventional respiratory physiotherapy, while the control group will receive only conventional respiratory physiotherapy.
Data collection will involve a range of tools to assess primary and secondary outcomes:
- Incentive Spirometry: Assesses lung function.
- Peak Flow Meter: Measures Peak Expiratory Flow (PEF), assessing expiratory flow rate during forced expiration.
- SF-12 Health Survey: Assesses health-related quality of life (HRQoL) across various physical and mental health aspects.
- Modified Borg Scale: Subjective assessment of perceived exertion and dyspnoea.
- Structured Questionnaire: To gather socio-demographic indicators and additional relevant data.
Data will be analyzed using SPSS version 22. Descriptive statistics will include pie charts, bar charts, and linear line diagrams. Parametric tests such as paired t-tests and unrelated t-tests will be employed to analyze the data. Variables such as mean, mean difference, standard deviations, standard error, degree of freedom, and significance level will be calculated to demonstrate significant differences within and between the experimental and control groups.
By conducting this trial, the study aims to provide robust evidence on the potential benefits of RIMT in improving respiratory function and overall quality of life in individuals with SCI.
- Being tested
- Usual Care
- Keywords
- SCI, Respiratory complication, Lung Function, RIMT, Conventional Physiotherapy
- 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.
Usual CareOther
Participants in the control group will recieve usual care.
| Study group | Role | What they receive |
|---|---|---|
| Resistive Inspiratory Muscle Training | Experimental | Participants in this group will perform resistive inspiratory muscle training, designed to strengthen respiratory muscles and improve lung function. Training involves inhaling through a device that provides resistance, performed five days a week for four weeks. Receives: Other: Usual Care |
| Usual Care | Active comparator | Participants in this group will receive conservative respiratory physiotherapy, which includes standard techniques aimed at maintaining respiratory function and managing symptoms. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function
The spirometer is a medical device used to measure lung function by assessing the volume of air inhaled and exhaled. During a spirometry test, the patient breathes into a mouthpiece connected to the spirometer, which records the amount and rate of air breathed in and out. Key measurements include forced vital capacity (FVC) and forced expiratory volume in one second (FEV1).
Measured: at baseline and after 4 week
Expiratory flow rate during forced expiration
The peak flow meter is a device used to measure how well air moves out of the lungs. It helps assess the peak expiratory flow rate (PEFR), which is the fastest rate at which a person can blow air out of their lungs after taking a deep breath.
Measured: at baseline and after 4 week
Health-Related Quality of Life (HRQoL)
The SF-12 is a validated and reliable health survey that measures health-related quality of life. It comprises 12 questions covering eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Responses are used to calculate summary scores for physical and mental health.
Measured: at baseline and after 4 week
Perceived exertion and dyspnoea
The Modified Borg Scale is a validated tool for measuring perceived exertion during physical activity, ranging from 0 (no exertion) to 10 (maximal exertion). It allows individuals to rate their effort intensity, serving as a subjective measure of physical strain.
Measured: at baseline and after 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injury (SCI), Respiratory ComplicationStudies 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
- Model description
- This study is a double-blinded randomized controlled trial (RCT), where both participants and assessors were blinded. Participants were randomly allocated to either the experimental group, receiving resistive inspiratory muscle training, or the control group, receiving usual care, allocated using a lottery method.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dhaka
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dolan Chapa Lucky, University of Dhaka
- Investigators
- Prof. Dr. Mohammad Anwar Hossain, PhD, Study chair, Professor & Head of Department of Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547606
- Sponsor's protocol ID
- CRP-BHPI/IRB/07/2024/900
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants' demographic details, such as their names and contact information, will be kept confidential by the primary investigator until the publication of the study results. After publication, this information will be discarded.
Publications
Gee CM, Williams AM, Sheel AW, Eves ND, West CR. Respiratory muscle training in athletes with cervical spinal cord injury: effects on cardiopulmonary function and exercise capacity. J Physiol. 2019 Jul;597(14):3673-3685. doi: 10.1113/JP277943. Epub 2019 Jun 11.
PubMed 31115056McDonald T, Stiller K. Inspiratory muscle training is feasible and safe for patients with acute spinal cord injury. J Spinal Cord Med. 2019 Mar;42(2):220-227. doi: 10.1080/10790268.2018.1432307. Epub 2018 Feb 5.
PubMed 29400990de Araujo Morais L, Cipriano G Jr, Martins WR, Chiappa GR, Formiga MF, Cipriano GFB. Inspiratory muscle training on quality of life in individuals with spinal cord injury: A systematic review and meta-analysis. Spinal Cord. 2023 Jul;61(7):359-367. doi: 10.1038/s41393-023-00906-1. Epub 2023 Jul 1.
PubMed 37393409Palermo AE, Butler JE, Boswell-Ruys CL. Comparison of two inspiratory muscle training protocols in people with spinal cord injury: a secondary analysis. Spinal Cord Ser Cases. 2023 Aug 12;9(1):42. doi: 10.1038/s41394-023-00594-2.
PubMed 37573384Postma K, Haisma JA, Hopman MT, Bergen MP, Stam HJ, Bussmann JB. Resistive inspiratory muscle training in people with spinal cord injury during inpatient rehabilitation: a randomized controlled trial. Phys Ther. 2014 Dec;94(12):1709-19. doi: 10.2522/ptj.20140079. Epub 2014 Jul 31.
PubMed 25082923Palermo AE, Cahalin LP, Nash MS. A case for inspiratory muscle training in SCI: potential role as a preventative tool in infectious respiratory diseases like COVID-19. Spinal Cord Ser Cases. 2020 Sep 17;6(1):87. doi: 10.1038/s41394-020-00337-7.
PubMed 32943611
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Resistive Inspiratory Muscle Training on Optimizing Lung Function in Individuals With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06547606
- Acronym / sponsor ID
- CRP-BHPI/IRB/07/2024/900
- Keywords
- SCI, Respiratory complication, Lung Function, RIMT, Conventional Physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of DhakaUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 9 Aug 2024 (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 goal of this clinical trial is to evaluate the effectiveness of resistive inspiratory muscle training (RIMT) in optimizing lung function in individuals with spinal cord injury (SCI). It will also learn about the safety and impact of RIMT on health-related quality of life in this population. The main questions it aims to answer are:
Does RIMT improve respiratory function in individuals with SCI? What impact does RIMT have on the health-related quality of life of participants? What are the perceived exertion or dyspnoea levels in participants undergoing RIMT? Researchers will compare RIMT to conventional respiratory physiotherapy to see if RIMT works to enhance lung function and improve overall respiratory outcomes in individuals with SCI.
Participants will:
Perform resistive inspiratory muscle training along with conventional respiratory physiotherapy 5 days a week for 4 weeks.
Detailed description
Globally, over 15 million people are living with spinal cord injury (SCI), according to the World Health Organization (WHO) in 2024. SCI disrupts the normal functioning of the spinal cord, leading to significant physical and neurological impairments. One of the major challenges in SCI management is respiratory complications, which contribute significantly to morbidity and mortality. Resistive inspiratory muscle training (RIMT) has emerged as a promising intervention to enhance respiratory muscle strength and function, potentially reducing respiratory complications in SCI.
The primary objective of this clinical trial is to evaluate the effectiveness of RIMT in optimizing lung function in individuals with SCI. The study also aims to assess the safety of RIMT and its impact on the health-related quality of life of participants.
Researchers will compare RIMT to conventional respiratory physiotherapy to see if RIMT works to enhance lung function and improve overall respiratory outcomes in individuals with SCI.
The study population will consist of individuals with cervical spinal cord injury (SCI) who have impaired respiratory function and are admitted for inpatient rehabilitation. The inclusion criteria include individuals aged 18 to 65 years with cervical cord injury and impaired respiratory function. Exclusion criteria include progressive diseases, head injury, psychiatric conditions, medical instability, ventilator dependency, and the presence of a tracheostomy.
The clinical trial will be conducted at the Spinal Cord Injury Unit of the Centre for the Rehabilitation of the Paralyzed (CRP) in Savar, Dhaka. The CRP provides comprehensive rehabilitation services to patients from all over Bangladesh, ensuring that the study population reflects a broad demographic and economic spectrum.
This study is designed as a randomized controlled trial (RCT) with participants randomly allocated to either the intervention group or the control group. The intervention group will receive resistive inspiratory muscle training (RIMT) in addition to conventional respiratory physiotherapy, while the control group will receive only conventional respiratory physiotherapy.
Data collection will involve a range of tools to assess primary and secondary outcomes:
- Incentive Spirometry: Assesses lung function.
- Peak Flow Meter: Measures Peak Expiratory Flow (PEF), assessing expiratory flow rate during forced expiration.
- SF-12 Health Survey: Assesses health-related quality of life (HRQoL) across various physical and mental health aspects.
- Modified Borg Scale: Subjective assessment of perceived exertion and dyspnoea.
- Structured Questionnaire: To gather socio-demographic indicators and additional relevant data.
Data will be analyzed using SPSS version 22. Descriptive statistics will include pie charts, bar charts, and linear line diagrams. Parametric tests such as paired t-tests and unrelated t-tests will be employed to analyze the data. Variables such as mean, mean difference, standard deviations, standard error, degree of freedom, and significance level will be calculated to demonstrate significant differences within and between the experimental and control groups.
By conducting this trial, the study aims to provide robust evidence on the potential benefits of RIMT in improving respiratory function and overall quality of life in individuals with SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a double-blinded randomized controlled trial (RCT), where both participants and assessors were blinded. Participants were randomly allocated to either the experimental group, receiving resistive inspiratory muscle training, or the control group, receiving usual care, allocated using a lottery method.
| Arm | Type | Receives |
|---|---|---|
| Resistive Inspiratory Muscle Training | Experimental | Other: Usual CareParticipants in this group will perform resistive inspiratory muscle training, designed to strengthen respiratory muscles and improve lung function. Training involves inhaling through a device that provides resistance, performed five days a week for four weeks. |
| Usual Care | Active comparator | Other: Usual CareParticipants in this group will receive conservative respiratory physiotherapy, which includes standard techniques aimed at maintaining respiratory function and managing symptoms. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- People with Traumatic Cervical Cord Injury
- Impaired respiratory function
Key exclusion criteria (1 listed)
- Participants who have Progressive diseases, Head injury, A psychiatric condition , Medical instability, Ventilator dependency, and Presence of tracheostomy
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 |
|---|---|---|
| Usual CareParticipants in the control group will recieve usual care. | Other | Resistive Inspiratory Muscle Training, Usual Care |
Primary outcome
Lung function
Time frame: at baseline and after 4 week
The spirometer is a medical device used to measure lung function by assessing the volume of air inhaled and exhaled. During a spirometry test, the patient breathes into a mouthpiece connected to the spirometer, which records the amount and rate of air breathed in and out. Key measurements include forced vital capacity (FVC) and forced expiratory volume in one second (FEV1).
Expiratory flow rate during forced expiration
Time frame: at baseline and after 4 week
The peak flow meter is a device used to measure how well air moves out of the lungs. It helps assess the peak expiratory flow rate (PEFR), which is the fastest rate at which a person can blow air out of their lungs after taking a deep breath.
Health-Related Quality of Life (HRQoL)
Time frame: at baseline and after 4 week
The SF-12 is a validated and reliable health survey that measures health-related quality of life. It comprises 12 questions covering eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Responses are used to calculate summary scores for physical and mental health.
Perceived exertion and dyspnoea
Time frame: at baseline and after 4 week
The Modified Borg Scale is a validated tool for measuring perceived exertion during physical activity, ranging from 0 (no exertion) to 10 (maximal exertion). It allows individuals to rate their effort intensity, serving as a subjective measure of physical strain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 31115056Gee CM, Williams AM, Sheel AW, Eves ND, West CR. Respiratory muscle training in athletes with cervical spinal cord injury: effects on cardiopulmonary function and exercise capacity. J Physiol. 2019 Jul;597(14):3673-3685. doi: 10.1113/JP277943. Epub 2019 Jun 11.
- Background: PubMed 29400990McDonald T, Stiller K. Inspiratory muscle training is feasible and safe for patients with acute spinal cord injury. J Spinal Cord Med. 2019 Mar;42(2):220-227. doi: 10.1080/10790268.2018.1432307. Epub 2018 Feb 5.
- Background: PubMed 37393409de Araujo Morais L, Cipriano G Jr, Martins WR, Chiappa GR, Formiga MF, Cipriano GFB. Inspiratory muscle training on quality of life in individuals with spinal cord injury: A systematic review and meta-analysis. Spinal Cord. 2023 Jul;61(7):359-367. doi: 10.1038/s41393-023-00906-1. Epub 2023 Jul 1.
- Results publication: PubMed 37573384Palermo AE, Butler JE, Boswell-Ruys CL. Comparison of two inspiratory muscle training protocols in people with spinal cord injury: a secondary analysis. Spinal Cord Ser Cases. 2023 Aug 12;9(1):42. doi: 10.1038/s41394-023-00594-2.
- Results publication: PubMed 25082923Postma K, Haisma JA, Hopman MT, Bergen MP, Stam HJ, Bussmann JB. Resistive inspiratory muscle training in people with spinal cord injury during inpatient rehabilitation: a randomized controlled trial. Phys Ther. 2014 Dec;94(12):1709-19. doi: 10.2522/ptj.20140079. Epub 2014 Jul 31.
- Results publication: PubMed 32943611Palermo AE, Cahalin LP, Nash MS. A case for inspiratory muscle training in SCI: potential role as a preventative tool in infectious respiratory diseases like COVID-19. Spinal Cord Ser Cases. 2020 Sep 17;6(1):87. doi: 10.1038/s41394-020-00337-7.
- Individual participant dataSharing planned: No. Participants' demographic details, such as their names and contact information, will be kept confidential by the primary investigator until the publication of the study results. After publication, this information will be discarded.
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.
Prof. Dr. Mohammad Anwar Hossain, PhD study chair
Professor & Head of Department of Physiotherapy
Questions about this trial
What is this clinical trial studying?
A study of Spinal Cord Injury (SCI), Respiratory Complication, run by University of Dhaka.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dolan Chapa Lucky, B.Sc(Hons) in Physiotherapy (+8801972304757, dcl.mrs7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function (time frame: at baseline and after 4 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06547606, which also lists 6 linked publications.
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 9 Aug 2024.