NCT06468371

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Lahore General Hospital · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Hemodialysis
• Restless Legs Syndrome
• ESRD (End Stage Renal Disease)
• Diabetes Complications

Interventions

Type	Name	Description
DRUG	Dopamine Agonist (Ropinirole)	Ropinirole administration will start at 0.25 mg orally once daily, two hours before bedtime. The dose will be adjusted weekly based on symptoms, increasing by 0.5 mg increments, up to a maximum of 2.0 mg, which will be maintained for the remaining 12 weeks.
OTHER	Excercise training	Exercise sessions will involve using a pedal bicycle twice a week for 12 weeks, integrated into the patients' hemodialysis schedule. Each session will last 20 minutes, scheduled between the second and third hours of dialysis. The first 5 minutes will be for warm-up with slow pedaling, followed by 10 minutes of intense pedaling, and concluding with a 5-minute cool-down period of slow pedaling to gradually reduce the heart rate.

Timeline

• Start date: 2022-01-02
• Primary completion: 2023-12-31
• Completion: 2024-02-01
• First posted: 2024-06-21
• Last updated: 2024-06-21

Locations

1 site across 1 country: Pakistan