Exercise Training Versus Ropinirole in Treating Restless Legs Syndrome Among Hemodialysis Patients

Hemodialysis Clinical Trial

Official title: Comparative Efficacy of Exercise Training Versus Dopamine Agonists in Treating Restless Legs Syndrome Among Hemodialysis Patients

Status Completed

Clinical Trial 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.

Clinical Trial 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 Department's 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 (0.25 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 Fisher's exact test for categorical variables and independent t-tests for continuous variables, with a significance level set at p<0.05. ;

Related Conditions & MeSH terms

• Diabetes Complications
• Hemodialysis
• Kidney Diseases
• Kidney Failure, Chronic
• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

• NCT number: NCT06468371
• Study type: Interventional
• Source: Lahore General Hospital
• Status: Completed
• Phase: N/A
• Start date: January 2, 2022
• Completion date: February 1, 2024