Clinical trial NCT06468371: Exercise Training Versus Ropinirole in Treating Restless Legs Syndrome Among Hemodialysis Patients
Official title: Comparative Efficacy of Exercise Training Versus Dopamine Agonists in Treating Restless Legs Syndrome Among Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Restless Legs Syndrome
ESRD (End Stage Renal Disease)
Diabetes Complications
Keywords: ESRD (End Stage Renal Disease)
Restless Legs Syndrome
Lead sponsor: Lahore General Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-21
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in the International Restless Legs Syndrome Study Group (IRLSSG) score
timeFrame: From baseline to 3 months of interval.
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Lahore General Hospital, Lahore
state: Punjab
Study officials:
affiliation: Lahore General Hospital, Lahore
name: Muhammad Irfan Jamil, MBBS, FCPS
role: PRINCIPAL_INVESTIGATOR
References: