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

NCT00942253 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2010-07-05

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Center for Research and Technology Thessaly - CERETETH

    collaborator UNKNOWN

  • European Social Fund

    collaborator OTHER

  • University of Thessaly

    lead OTHER

Principal Investigators

  • Giorgos K Sakkas, PhD · UTH - CERETETH

  • Ioannis Stefanidis, MD PhD · UTH

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2010-04-30
Completion
2010-07-31

Countries

  • Greece

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00942253 on ClinicalTrials.gov