Ignite Creation Date:
2024-07-17 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468371
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2024-05-17
Brief Title:
Exercise Training Versus Ropinirole in Treating Restless Legs Syndrome Among Hemodialysis Patients
Sponsor:
Lahore General Hospital
Organization:
Lahore General Hospital
Study Overview
Official Title:
Comparative Efficacy of Exercise Training Versus Dopamine Agonists in Treating Restless Legs Syndrome Among Hemodialysis Patients
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:
This research aims to compare the efficacy of these two interventions thereby addressing a critical gap in current therapeutic approaches The rationale for this study is rooted in the existing evidence supporting non-pharmacological and pharmacological interventions for RLS yet the comparative efficacy remains underexplored
Detailed Description:
The prevalence of end-stage kidney disease ESKD and its accompanying symptom burden particularly restless legs syndrome RLS signified an urgent need for effective treatment strategies RLS with its higher prevalence in hemodialysis patients posed significant challenges to their quality of life and overall health Our hypothesis posited that there would be a significant difference in the effectiveness of exercise training versus dopamine agonist therapy in improving International Restless Legs Syndrome scores among hemodialysis patients This research aimed to compare the efficacy of these two interventions thereby addressing a critical gap in current therapeutic approaches The rationale for this study was rooted in the existing evidence supporting non-pharmacological and pharmacological interventions for RLS yet the comparative efficacy remained underexplored The objective was to conduct a prospective comparative study within the Nephrology Departments Dialysis Unit at Sheikh Zayed Hospital Rahim Yar Khan with a sample size of 48 comprising 24 patients in each group Adult patients both male and female diagnosed with ESKD and undergoing maintenance hemodialysis who also met the criteria for RLS were included Group A received the dopamine agonist ropinirole starting at a low dose 025 mg and titrated according to symptomatology while Group B underwent a structured exercise regimen on a pedal bicycle during their dialysis sessions The outcome of this study was the change in IRLSS scores from baseline to 3 months post-intervention Follow-up assessments were meticulously conducted to monitor these changes with data recorded on a proforma designed for accuracy and consistency Our data analysis plan involved chi-square or Fishers exact test for categorical variables and independent t-tests for continuous variables with a significance level set at p005
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?:
False
Is an FDA AA801 Violation?:
None