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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Complications; Restless Legs Syndrome; Hemodialysis; ESRD (End Stage Renal Disease)
• Intervention / Treatment: Drug: Dopamine Agonist (Ropinirole); Other: Excercise training

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Lahore General Hospital, Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dopamine agonist; Ropinirole administration was begun with a dose of 0.25 mg, taken orally once daily, two hours before bedtime.; The dose was adjusted based on symptomatology at weekly intervals, with an increment of 0.5 mg, targeting a maximum dose of 2.0 mg, which was maintained for the remaining duration of the 12 weeks	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 Names: Ropinirole
Experimental: Excercise training; Exercise sessions involved using a pedal bicycle twice a week for 12 weeks, integrated into the patient's hemodialysis schedule.; Each exercise session lasted 20 minutes, scheduled between the second and third hours of dialysis.; The first 5 minutes were served as a warm-up, consisting of slow pedaling.; This was followed by 10 minutes of more intense pedaling.; After the initial 15 minutes, the pace was slow again for another 5 minutes for a cool-down period, helping to gradually reduce the heart rate.	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.; Other Names: Physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Lahore General Hospital
• Investigators: Principal Investigator: Muhammad Irfan Jamil, MBBS, FCPS, Lahore General Hospital, Lahore

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: June 15, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 15, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Restless Legs Syndrome; ESRD (End Stage Renal Disease)
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Urologic Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Endocrine System Diseases; Disease Attributes; Disease; Diabetes Mellitus; Renal Insufficiency; Dyskinesias; Psychomotor Disorders; Parasomnias; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Aberrant Motor Behavior in Dementia; Syndrome; Kidney Diseases; Psychomotor Agitation; Restless Legs Syndrome; Kidney Failure, Chronic; Diabetes Complications; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Cardiotonic Agents; Dopamine Agents; Sympathomimetics; Antiparkinson Agents; Anti-Dyskinesia Agents; Dopamine; Ropinirole; Dopamine Agonists
• Other Study ID Numbers: LahoreGeneralH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No