Ignite Creation Date:
2024-05-06 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05300074
Status:
TERMINATED
Last Update Posted:
2024-04-17
First Post:
2022-03-08
Brief Title:
Equivalence Test of Two Different Inspiratory Muscle Training Protocols a Randomised Controlled Trial
Sponsor:
Spinal Cord Injury Centre of Western Denmark
Organization:
Spinal Cord Injury Centre of Western Denmark
Study Overview
Official Title:
Equivalence Test of Two Different Inspiratory Muscle Training Protocols a Randomised Controlled Trial
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
adjustments needed after pilot period and delay because of reduced staff
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to investigate if six weeks of high intensity Inspiratory Muscle Training IMT performed two times a week has the same effect as five times a week in hospitalized patients with first time Spinal Cord Injury SCI
Design methods A Randomised controlled trial RCT including 60 patients with reduced Maximal Inspiration Pressure MIP will be recruited at two specialized SCI centers in Denmark Primary outcome is MIP after six weeks of training Secondary outcome will be reported on Rating Perceived Exertion RPE voice performance Quality Of Life QOLand sleep quality Furthermore long term follow-up at 12 months after start of intervention will also be performed
Design methods A Randomised controlled trial RCT including 60 patients with reduced Maximal Inspiration Pressure MIP will be recruited at two specialized SCI centers in Denmark Primary outcome is MIP after six weeks of training Secondary outcome will be reported on Rating Perceived Exertion RPE voice performance Quality Of Life QOLand sleep quality Furthermore long term follow-up at 12 months after start of intervention will also be performed
Detailed Description:
Background SCI may result in various disabilities including both physical cognitive emotional and social domains Motor function and function of the respiratory muscles are often decreased and may influence the patients activities of daily activities and QOL IMT is training to improve the strength and endurance of diaphragm and the external intercostal muscles Various training protocols of IMT have shown efficient to increase lung function Although a recent meta-analysis suggest that high intensity training may be more efficient it is less clear at what weekly frequency IMT should be performed
Thus the objective of this study is to investigate if six weeks of high intensity IMT performed two times a week has the same effect as five times a week in hospitalized patients with first time SCI
Design methods A Randomised controlled trial RCT including 60 patients with reduced MIP will be recruited at two specialized SCI centers in Denmark Primary outcome is MIP after six weeks of training Secondary outcome will be reported on end of treatment and long term follow-up 12 months after start of intervention in RPE voice performance QOL and sleep quality The two intervention arms will consist of one arm training two times a week and the other arm training five times a week The training protocol in both arms will include five rounds of IMT with 12 repetitions at 60 of MIP MIP will be increased 10 every week if tolerated by the patient until 80 of MIP is reached After six weeks patients are motivated to continue training by themself up to 12 months after start of intervention
Thus the objective of this study is to investigate if six weeks of high intensity IMT performed two times a week has the same effect as five times a week in hospitalized patients with first time SCI
Design methods A Randomised controlled trial RCT including 60 patients with reduced MIP will be recruited at two specialized SCI centers in Denmark Primary outcome is MIP after six weeks of training Secondary outcome will be reported on end of treatment and long term follow-up 12 months after start of intervention in RPE voice performance QOL and sleep quality The two intervention arms will consist of one arm training two times a week and the other arm training five times a week The training protocol in both arms will include five rounds of IMT with 12 repetitions at 60 of MIP MIP will be increased 10 every week if tolerated by the patient until 80 of MIP is reached After six weeks patients are motivated to continue training by themself up to 12 months after start of intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None