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

About this trial

Last updated 2 years ago

Study ID

LahoreGeneralH

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Accepting

18 to 60 Years

All Sexes

Trial Timing

Ended 2 years ago

What is this trial about?

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.

What are the participation requirements?

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.