Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448598
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2024-06-04
Brief Title:
Exercise as an Adjunctive Therapy for Patients on Maintenance Hemodiafiltration
Sponsor:
Federal University of São Paulo
Organization:
Federal University of São Paulo
Study Overview
Official Title:
Exercise as an Adjunctive Therapy for Patients on Maintenance Hemodiafiltration A 6- Month Analysis
Status:
COMPLETED
Status Verified Date:
2024-06
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:
Patients with chronic kidney disease suffer from uremic toxin accumulation Treatments with hemodiafiltration demonstrate the highest capacity for removing solutes as well as improving mortality While exercise has been proven as an adjunct therapy in patients on maintenance hemodialysis little is known about the exercise influence in maintenance hemodiafiltration programs
Methods A retrospective observational study of chronic kidney disease patients at Fenix Nephrology group from 2021 until 2023 Patients were assessed at the start of the exercise program and after six months of rehabilitation Physical tests included a step-test for endurance handgrip and one-repetition maximum for muscle strength The Kidney Disease Quality of Life Short Form evaluated patient-reported outcomes KtV urea and urea reduction ratio were surrogates for hemodiafiltration adequacy Patients carried out twice weekly aerobic exercises at 70 of the maximum heart rate during the step test and resistance exercises at 60 of one-repetition maximum
Methods A retrospective observational study of chronic kidney disease patients at Fenix Nephrology group from 2021 until 2023 Patients were assessed at the start of the exercise program and after six months of rehabilitation Physical tests included a step-test for endurance handgrip and one-repetition maximum for muscle strength The Kidney Disease Quality of Life Short Form evaluated patient-reported outcomes KtV urea and urea reduction ratio were surrogates for hemodiafiltration adequacy Patients carried out twice weekly aerobic exercises at 70 of the maximum heart rate during the step test and resistance exercises at 60 of one-repetition maximum
Detailed Description:
The objectives of this study were twofold first to understand if hemodiafiltration HDF combined with exercise is a safe and effective treatment for patients with end-stage renal disease ESRDCKD 5D and second to explore the efficacy of exercise performed during dialysis sessions intradialytic versus between sessions interdialytic
The study employed a retrospective observational design analyzing data from CKD 5D patients undergoing maintenance HDF at the Fenix Nephrology group between 2021 and 2023 Inclusion criteria stipulated that participants were aged 18 years or older on HDF with optimized medication and agreed to participate in the exercise program with at least 80 adherence Assessments were conducted at baseline and after six months of rehabilitation including a step-test for endurance handgrip strength measurement one-repetition maximum 1RM test for muscle strength and the Kidney Disease Quality of Life Short Form KDQOL-SF questionnaire KtV and urea reduction ratio URR were used as surrogates for HDF adequacy
The exercise protocol involved twice-weekly sessions with aerobic exercises performed at 70 of the maximum heart rate achieved during the step test and resistance exercises at 60 of 1RM Participants self-selected their exercise timing either intradialytic during HDF sessions or interdialytic on non-dialysis days For the intradialytic group exercise was seamlessly integrated into the HDF session excluding the initial and final two hours of dialysis
The study employed a retrospective observational design analyzing data from CKD 5D patients undergoing maintenance HDF at the Fenix Nephrology group between 2021 and 2023 Inclusion criteria stipulated that participants were aged 18 years or older on HDF with optimized medication and agreed to participate in the exercise program with at least 80 adherence Assessments were conducted at baseline and after six months of rehabilitation including a step-test for endurance handgrip strength measurement one-repetition maximum 1RM test for muscle strength and the Kidney Disease Quality of Life Short Form KDQOL-SF questionnaire KtV and urea reduction ratio URR were used as surrogates for HDF adequacy
The exercise protocol involved twice-weekly sessions with aerobic exercises performed at 70 of the maximum heart rate achieved during the step test and resistance exercises at 60 of 1RM Participants self-selected their exercise timing either intradialytic during HDF sessions or interdialytic on non-dialysis days For the intradialytic group exercise was seamlessly integrated into the HDF session excluding the initial and final two hours of dialysis
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