Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS) (HDRLS)
Restless Legs Syndrome, End Stage Renal Disease, Hemodialysis
About this trial
This is an interventional supportive care trial for Restless Legs Syndrome focused on measuring RLS, Muscle, Dialysis, exercise, dopamine agonist, Sleep
Eligibility Criteria
Inclusion Criteria:
- Clinically stable hemodialysis patients with positive diagnosis in IRLSS questionnaire for the RLS will be eligible to participate. Entry criteria included being on chronic hemodialysis for six months, able to perform an exercise training, with dialysis delivery (KT/V) > 1.1.
Exclusion Criteria:
- Patients were excluded from the study if they were diagnosed with neuropathies or reasons for being in a catabolic state (including malignancies, HIV and opportunistic infections, active inflammation), within 3 months prior to the start of the study. In addition patients treated with drugs recommended for the treatment of RLS as well as patients with Parkinson's disease or untreated depression will be also excluded.
Sites / Locations
- University Hospital of Larissa, Nephrology Clinic
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Dopamine Agonist Group
Placebo Group
Dialysis patients will receive dopamine agonist for 24 weeks following a 24 weeks period of combined treatment with dopamine agonist and aerobic intradialytic exercise. Patients will be given evening doses of dopamine agonists, 2 hours before bedtime. The dopamine agonists' dose will be 0.25 mg/dose and remain constant until the end of the study.
Dialysis patients will receive placebo for 24 weeks following a 24 weeks period of combined treatment with placebo and aerobic intradialytic exercise. Patients will be given evening doses of placebo, 2 hours before bedtime.