Clinical trial NCT06547606: Effect of Resistive Inspiratory Muscle Training Optimizing Lung Function in Spinal Cord Injury
Official title: The Effect of Resistive Inspiratory Muscle Training on Optimizing Lung Function in Individuals With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injury (SCI), Respiratory Complication
Keywords: SCI, Respiratory complication, Lung Function, RIMT, Conventional Physiotherapy
Lead sponsor: University of Dhaka
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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:

1. Incentive Spirometry: Assesses lung function.
2. Peak Flow Meter: Measures Peak Expiratory Flow (PEF), assessing expiratory flow rate during forced expiration.
3. SF-12 Health Survey: Assesses health-related quality of life (HRQoL) across various physical and mental health aspects.
4. Modified Borg Scale: Subjective assessment of perceived exertion and dyspnoea.
5. 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.

Eligibility criteria: Inclusion Criteria:

* People with Traumatic Cervical Cord Injury
* Impaired respiratory function

Exclusion Criteria:

* Participants who have Progressive diseases, Head injury, A psychiatric condition , Medical instability, Ventilator dependency, and Presence of tracheostomy

Primary outcomes:
measure: Lung function
timeFrame: at baseline and after 4 week
measure: Expiratory flow rate during forced expiration
timeFrame: at baseline and after 4 week
measure: Health-Related Quality of Life (HRQoL)
timeFrame: at baseline and after 4 week
measure: Perceived exertion and dyspnoea
timeFrame: at baseline and after 4 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Professor & Head of Department of Physiotherapy
name: Prof. Dr. Mohammad Anwar Hossain, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: McDonald 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.
citation: de 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.
citation: Palermo 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.
citation: Postma 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.
citation: Palermo 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.