A Phase 2 interventional study of Dopamine Agonist and Exercise in Restless Legs Syndrome, End Stage Renal Disease and Hemodialysis, sponsored by University of Thessaly. Completed at 1 site in Greece. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-07-05.
Sponsored by University of Thessaly · Phase 2, Interventional, and Supportive care
Uremic etiology Restless legs syndrome (RLS) has been associated with poorer quality of life (QoL) compared to RLS-free counterparts mainly due to sleep deprivation factors. Exercise training in hemodialysis (HD) patients with RLS has been proven to be a safe approach in temporally ameliorating RLS symptoms similarly to the use of pharmacological treatment with dopamine agonists. However it not known whether the exercise anabolic stimulus and the dopamine agonist treatment could act synergistically for the improvement of physical functioning and muscle performance as well as in the amelioration of augmentation symptoms in hemodialysis patients with RLS.
This is a randomized, placebo-controlled study to evaluate the acute and long term (6 months) effect of exercise training in combination with dopamine agonists in quality of life, muscle function, sleep quality and metabolism in patients with restless legs syndrome (RLS) receiving dialysis therapy.
Objectives - Aims:
788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.
This study's planned enrollment of 46 is below the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →University of Thessaly is the lead sponsor of 188 studies on the registry; 44 are open to participants now.
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Exclusion Criteria:
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.
Other: Dopamine Agonist and Exercise
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.
Other: Dopamine Agonist and Exercise
Dialysis patients will receive dopamine agonist or placebo for 24 weeks following a 24 weeks period of combined treatment with dopamine agonist or placebo and aerobic intradialytic exercise.
IRLS severity scale
Time frame: 24 and 48 wks
Quality of Life Quality of Sleep Functional Capacity Muscle Size and composition Body Composition Glucose Tolerance Heart and respiratory functionality
Time frame: 24 and 48 wks
This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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University of Thessaly