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

NCT ID: NCT06468371

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-02
• Study Completion Date: 2024-02-01

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Dopamine Agonist (Ropinirole)

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Excercise training

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Ropinirole; Physiotherapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lahore General Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Muhammad Irfan Jamil

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammad Irfan Jamil, MBBS, FCPS

Role: PRINCIPAL_INVESTIGATOR

Lahore General Hospital, Lahore

Locations

Lahore General Hospital, Lahore

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

LahoreGeneralH

Identifier Type: -

Identifier Source: org_study_id