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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06468371
• Other study ID #: LahoreGeneralH
• Status: Completed
• Phase: N/A
• Start date: January 2, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: June 2024
• Source: Lahore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Adult patients aged 18-60 years.

• Both male and female.

• Diagnosed with end-stage kidney disease (ESKD) and currently undergoing twice weekly maintenance hemodialysis for at least 3 months.

• Diagnosed with restless legs syndromeas defined by the International Restless Legs Syndrome Scale (IRLSS) criteria, with an IRLSSscore of 10 or higher at baseline.

• Able to participate in physical exercise as assessed by a healthcare professional.

• Patients must exhibit normal serum electrolyte levels, including potassium (3.5-5.0 mmol/L), calcium (8.5-10.2 mg/dL), phosphate (2.5-4.5 mg/dL), magnesium (1.7-2.2 mg/dL), and intact parathyroid hormone (iPTH) (150 to 600 pg/mL), as confirmed by recent laboratory tests.

Exclusion Criteria:

• Presence of other medical conditions that significantly impair mobility (e.g., severe arthritis, recent fractures, or amputations).

• Patients diagnosed with other neuropathies as assessed by neurologists.

• Patients in catabolic state with active infection, inflammation (C-reactive protein blood levels above 5.0 mg/l) or malignancy.

• Patients with diagnosed iron deficiency, defined by transferrin saturation less than 20%.

• Patients diagnosed with myocardial infarction or unstable angina over the last twelve months, existing heart failure or liver disease, poorly controlled diabetes (RBS = 250 mg/dl) and uncontrolled hypertension with systolic blood pressure=200 mmHg and /or diastolic blood pressure=120 mmHg on two separate occasions.

• Patients requiring =13 mL/kg/hour ultrafiltration routinely as assessed by dialysis records.

• History of allergic reactions or contraindications to dopamine agonists if assigned to the pharmacological treatment group.

• Cognitive impairments or psychiatric conditions that may hinder understanding of the study requirements or compliance with the protocol.

• Patients refused to participate in the study.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Lahore General Hospital, Lahore	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Lahore General Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the International Restless Legs Syndrome Study Group (IRLSSG) score	The IRLSS score is a validated instrument used to assess the severity of Restless Legs Syndrome (RLS). It comprises ten questions that evaluate the intensity of symptoms, their impact on sleep and daily life, and the frequency of symptom occurrence. Each question is rated on a scale from 0 (no symptoms) to 4 (severe symptoms). The overall score ranges from 0 to 40.	From baseline to 3 months of interval.