Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547606
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Effect of Resistive Inspiratory Muscle Training Optimizing Lung Function in Spinal Cord Injury
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Resistive Inspiratory Muscle Training on Optimizing Lung Function in Individuals With Spinal Cord Injury
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None