Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05722496
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2023-01-23
Brief Title:
Difference Between Interval and Continous Intradialytic Exercise on Functional Capacity in Hemodialysis Patient
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Interval Versus Continous Intradialytic Training on Muscla Quality Index and Functional Capacity in Hemodialysis Patients
Status:
COMPLETED
Status Verified Date:
2023-09
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:
The goal of this study is to find out the effect of interval versus continous intradialytic training on muscle quality index and functional capacity in Hemodialysis patients The main question it aims to answer is
Does interval versus continous intradialytic training have an effect on muscle quality index and functional capacity in hemodialysis patients Patients will be assigned randomly by computerized block randomization into two groupsGroup A 30 patients will participate in 8 weeks of aerobic exercise in the form of high intensity interval training HIIT intradialytic pedaling exercise plus hemodialysis 3 sessions per weekGroup B 30 patients will participate in 8 weeks of aerobic exercise in the form of moderate intensity continous training MICT intradialytic pedaling exercise plus hemodialysis 3 sessions per week primary and secondary variables will be measured before starting treatment and after completion after 2 months
Does interval versus continous intradialytic training have an effect on muscle quality index and functional capacity in hemodialysis patients Patients will be assigned randomly by computerized block randomization into two groupsGroup A 30 patients will participate in 8 weeks of aerobic exercise in the form of high intensity interval training HIIT intradialytic pedaling exercise plus hemodialysis 3 sessions per weekGroup B 30 patients will participate in 8 weeks of aerobic exercise in the form of moderate intensity continous training MICT intradialytic pedaling exercise plus hemodialysis 3 sessions per week primary and secondary variables will be measured before starting treatment and after completion after 2 months
Detailed Description:
Individuals with CKD both predialysis and ESRD may be at greater risk of sarcopenia given the combined reductions in physical function skeletal muscle performance and skeletal muscle mass
Study include sixty male patients on hemodialysis for 1-3 years aged from 45 to 55 years old selected from hemodialysis unit at National Institute of Urology and Nephrology Before starting treatment patients will fill consent form and the study aims and procedure will be explained to each patient study include Sixty male patients on hemodialysis for 1-3 years aged from 45 to 55 years old selected from hemodialysis unit at National Institute of Urology and Nephrology Patients will be assigned randomly by computerized block randomization into two groupsGroup A 30 patients will participate in 8 weeks of aerobic exercise in the form of high intensity interval training HIIT intradialytic pedaling exercise plus hemodialysis 3 sessions per weekGroup B 30 patients will participate in 8 weeks of aerobic exercise in the form of moderate intensity continous training MICT intradialytic pedaling exercise plus hemodialysis 3 sessions per week Karvonen formula will be used to calculate training heart rate THR RHR HRmax - RHR 65-80 AS HRmax 220-Age patients of HIIT will perform aerobic exercise in the form of leg pedaling exercise in semi-supine position using leg ergometer at high intensity 85-95 of HRpeak with 4 min of active breaks at an intensity of 60-70 of HRpeak Exercise will be done at the first 2 hours of dialysis to avoid dialysis hypotension episodes
patients of MICT will perform aerobic exercise in the form of leg pedaling exercise in semi-supine position using leg ergometer at moderate intensity 50-60 of HRpeak Exercise will be done at the first 2 hours of dialysis to avoid dialysis hypotension episodes
primary and secondary variables will be measured before starting treatment and after completion after 2 months
Study include sixty male patients on hemodialysis for 1-3 years aged from 45 to 55 years old selected from hemodialysis unit at National Institute of Urology and Nephrology Before starting treatment patients will fill consent form and the study aims and procedure will be explained to each patient study include Sixty male patients on hemodialysis for 1-3 years aged from 45 to 55 years old selected from hemodialysis unit at National Institute of Urology and Nephrology Patients will be assigned randomly by computerized block randomization into two groupsGroup A 30 patients will participate in 8 weeks of aerobic exercise in the form of high intensity interval training HIIT intradialytic pedaling exercise plus hemodialysis 3 sessions per weekGroup B 30 patients will participate in 8 weeks of aerobic exercise in the form of moderate intensity continous training MICT intradialytic pedaling exercise plus hemodialysis 3 sessions per week Karvonen formula will be used to calculate training heart rate THR RHR HRmax - RHR 65-80 AS HRmax 220-Age patients of HIIT will perform aerobic exercise in the form of leg pedaling exercise in semi-supine position using leg ergometer at high intensity 85-95 of HRpeak with 4 min of active breaks at an intensity of 60-70 of HRpeak Exercise will be done at the first 2 hours of dialysis to avoid dialysis hypotension episodes
patients of MICT will perform aerobic exercise in the form of leg pedaling exercise in semi-supine position using leg ergometer at moderate intensity 50-60 of HRpeak Exercise will be done at the first 2 hours of dialysis to avoid dialysis hypotension episodes
primary and secondary variables will be measured before starting treatment and after completion after 2 months
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