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NCT06468371Completed

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

Source: ClinicalTrials.gov · Last updated 21 Jun 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
84 (actual)
First submitted
17 May 2024
Start date
2 Jan 2022
Primary completion date
31 Dec 2023
Lead sponsor
Lahore General Hospital
NCT number
NCT06468371

What you commit to

  • Study type: Interventional
  • Participants enrolled: 84
  • From 2 Jan 2022 to the primary completion date, 31 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Presence of other medical conditions that significantly impair mobility (e.g., severe arthritis, recent fractures, or amputations).
  • Patients in catabolic state with active infection, inflammation (C-reactive protein blood levels above 5.0 mg/l) or malignancy.
  • 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.

Lab values

  • 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.

Other

  • Patients diagnosed with other neuropathies as assessed by neurologists.
  • Patients with diagnosed iron deficiency, defined by transferrin saturation less than 20%.
  • Patients requiring ≥13 mL/kg/hour ultrafiltration routinely as assessed by dialysis records.
  • Patients refused to participate in the study.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Lahore General Hospital, Lahore
Coordinator of this site? Confirm its status
LahorePakistanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.