Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04660383
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-11-22
First Post:
2020-12-01
Brief Title:
Intradialytic Inspiratory Muscle Training at Different Intensities and Functional Capacity
Sponsor:
Hospital de Clinicas de Porto Alegre
Organization:
Hospital de Clinicas de Porto Alegre
Study Overview
Official Title:
Effects of Intradialytic Inspiratory Muscle Training at Different Intensities on Diaphragm Hypertrophy and Functional Capacity in Patients Undergoing Hemodialysis a Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Investigate the effects of Inspiratory Muscle Training IMT performed during hemodialysis HD procedures in patients with end stage kidney disease ESKD With intervention of thirty-six IMT sessions performed three times a week at an intensity of 50 30 and 10 sham of the maximum inspiratory pressure MIP
Detailed Description:
Introduction Chronic kidney disease CKD especially in its final stage ESKD is associated with an increased risk of cardiovascular complications and mortality Part of this risk can be attributed to the fact that patients with ESKD adopt sedentary behavior
Objectives To investigate the effects of Inspiratory Muscle Training IMT performed during hemodialysis HD procedures in patients with ESKD
Methodology Randomized double-blind clinical trial controlled by sham Location Nephrology Sector Hospital de Clínicas de Porto Alegre HCPA Participants three groups of 12 patients with ESKD on HD randomized to three IMT intensities
Intervention Thirty-six IMT sessions performed three times a week at an intensity of 50 30 and 10 sham of the maximum inspiratory pressure Pimax
Main outcomes Functional capacity diaphragm hypertrophy respiratory muscle strength lung volume blood pressure and quality of life
Statistical Analysis Presentation of data in absolute and relative numbers and through means and standard deviations To compare the groups ANOVA will be used with significance less than 005
Objectives To investigate the effects of Inspiratory Muscle Training IMT performed during hemodialysis HD procedures in patients with ESKD
Methodology Randomized double-blind clinical trial controlled by sham Location Nephrology Sector Hospital de Clínicas de Porto Alegre HCPA Participants three groups of 12 patients with ESKD on HD randomized to three IMT intensities
Intervention Thirty-six IMT sessions performed three times a week at an intensity of 50 30 and 10 sham of the maximum inspiratory pressure Pimax
Main outcomes Functional capacity diaphragm hypertrophy respiratory muscle strength lung volume blood pressure and quality of life
Statistical Analysis Presentation of data in absolute and relative numbers and through means and standard deviations To compare the groups ANOVA will be used with significance less than 005
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