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

NCT06468371 | Completed DMC

• 1 other identifier: LahoreGeneralH
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

ESRD (End Stage Renal Disease); Restless Legs Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Dopamine agonist

ACTIVE COMPARATOR

* 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)

Excercise training

EXPERIMENTAL

* 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

Interventions

Dopamine Agonist (Ropinirole) 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.

Also known as: Ropinirole

Dopamine agonist

Excercise training 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.

Also known as: Physiotherapy

Excercise training

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lahore General Hospital: lead

Study Sites (1)

Lahore General Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Restless Legs Syndrome; Renal Insufficiency, Chronic; Diabetes Complications

Interventions

Dopamine Agonists; ropinirole; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Therapeutics; Rehabilitation

Study Officials

• Muhammad Irfan Jamil, MBBS, FCPS

  Lahore General Hospital, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: June 21, 2024
• Study Start: January 2, 2022
• Primary Completion: December 31, 2023
• Study Completion: February 1, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

PA (1)