NCT00942253

Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS)

The Effects of Exercise Training in Combination With Dopamine Agonist to Physical Fitness Parameters and Quality of Life in Dialysis Patients With the Restless Legs Syndrome.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: University of Thessaly · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: 1. To investigate whether a single bout of intradialytic exercise session could have an effect in motor restlessness often seen during hemodialysis session in patients with RLS 2. To investigate whether a 24 weeks therapy with dopamine agonist or placebo will have an effect in sleep quality, functional capacity and metabolic profile of the hemodialysis patients with RLS 3. To examine whether dopamine agonists or placebo and aerobic intradialytic exercise act synergistically for the improvement of physical functioning and muscle performance as well as it could reduce the signs of augmentation in hemodialysis patients with RLS

Conditions

• Restless Legs Syndrome
• End Stage Renal Disease
• Hemodialysis
• Muscle Cachexia
• Sleep Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-09-01
• Primary completion: 2010-04-01
• Completion: 2010-07-01
• First posted: 2009-07-20
• Last updated: 2010-07-05

Locations

1 site across 1 country: Greece