Ignite Creation Date:
2024-05-06 @ 8:29 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02757456
Status:
COMPLETED
Last Update Posted:
2017-04-06
First Post:
2012-11-19
Brief Title:
Exercise and Vascular Parameters in Hemodialysis
Sponsor:
Sameena Iqbal
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
Aerobic Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population
Status:
COMPLETED
Status Verified Date:
2016-04
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:
Arterial calcification is very common in the incident hemodialysis population ranging 71-83Given that cardiovascular disease is a major cause of mortality in the hemodialysis population medial arterial calcification may contribute through increased risk of sudden death and congestive heart failure Applanation tonometry is the method of choice to measure pulse wave velocity and pulse wave analysis The primary objective will be to assess the effect of a 16 week exercise program on aortic pulse wave velocity as the vascular parameter and gait speed as the physical functioning parameter The secondary objectives will assess the effect of the exercise program on ultrafiltration rates weight SBP DBP BNP hsTroponin serum calcium phosphate albumin glucose LDL HDL TG glycated hemoglobin hemoglobin CRP micro RNAs 21 126 133 146a 221222 and 210 and hospitalizations
Detailed Description:
The investigators propose a pilot project to assess the effect of a 16 week aerobic exercise program on arterial stiffness and cardiovascular risk in the hemodialysis population The primary objective will be to assess the effect of a 16 week exercise program on aortic pulse wave velocity as the vascular parameter and gait speed as the physical functioning parameter The secondary objectives will assess the effect of the exercise program on ultrafiltration rates weight SBP DBP BNP hsTroponin serum calcium phosphate albumin glucose LDL HDL TG glycated hemoglobin hemoglobin CRP micro RNAs 21 126 133 146a 221222 and 210 and hospitalizations
Study Design
Randomized-controlled study of end stage renal disease patients between the age of 18 and 90 years to assess the effect of exercise on arterial stiffness Our aim is to have 23 patients in both groups The study period will be 24 weeks-4 weeks for recruitment 16 weeks for the intervention and 4 weeks for data collection and analysis The protocol will be submitted to the MUHC Research Ethics Board
The following outcomes are of interest
1 change in gait speed before and after the exercise program
2 change in pulse wave velocity before and after the exercise program
3 change in BNP blood pressure dialysis ultrafiltration hemoglobin micro RNAs before and after the exercise program
Study Design
Randomized-controlled study of end stage renal disease patients between the age of 18 and 90 years to assess the effect of exercise on arterial stiffness Our aim is to have 23 patients in both groups The study period will be 24 weeks-4 weeks for recruitment 16 weeks for the intervention and 4 weeks for data collection and analysis The protocol will be submitted to the MUHC Research Ethics Board
The following outcomes are of interest
1 change in gait speed before and after the exercise program
2 change in pulse wave velocity before and after the exercise program
3 change in BNP blood pressure dialysis ultrafiltration hemoglobin micro RNAs before and after the exercise program
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