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

This study has been completed.
Sponsor:
Collaborators:
Center for Research and Technology Thessaly - CERETETH
European Social Fund
Information provided by:
University of Thessaly
ClinicalTrials.gov Identifier:
NCT00942253
First received: July 17, 2009
Last updated: July 2, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Restless Legs Syndrome
End Stage Renal Disease
Hemodialysis
Muscle Cachexia
Sleep Disorders
Other: Dopamine Agonist and Exercise
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by University of Thessaly:

Primary Outcome Measures:
  • IRLS severity scale [ Time Frame: 24 and 48 wks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: September 2006
Study Completion Date: July 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dopamine Agonist 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.

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.
Placebo Comparator: Placebo Group

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.

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00942253

Locations
Greece
University Hospital of Larissa, Nephrology Clinic
Larissa, Thessaly, Greece, 41110
Sponsors and Collaborators
University of Thessaly
Center for Research and Technology Thessaly - CERETETH
European Social Fund
Investigators
Principal Investigator: Giorgos K Sakkas, PhD UTH - CERETETH
Study Chair: Ioannis Stefanidis, MD PhD UTH
  More Information

No publications provided by University of Thessaly

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Giorgos K. Sakkas, University of Thessaly
ClinicalTrials.gov Identifier: NCT00942253     History of Changes
Other Study ID Numbers: 3745/EPE/2006, 04EP-07/8.3/04EP-Greece
Study First Received: July 17, 2009
Last Updated: July 2, 2010
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by University of Thessaly:
RLS
Muscle
Dialysis
exercise
dopamine agonist
Sleep

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Parasomnias
Psychomotor Agitation
Restless Legs Syndrome
Sleep Disorders
Syndrome
Disease
Dyskinesias
Dyssomnias
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes
Psychomotor Disorders
Renal Insufficiency
Renal Insufficiency, Chronic
Signs and Symptoms
Sleep Disorders, Intrinsic
Urologic Diseases
Dopamine
Dopamine Agents
Dopamine Agonists
Autonomic Agents
Cardiotonic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 23, 2014