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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
ENTER - EU Social Fund - General Secretariat for Research and Technology
Information provided by:
University of Thessaly
ClinicalTrials.gov Identifier:
NCT00942253
First received: July 17, 2009
Last updated: July 2, 2010
Last verified: July 2010
History of Changes

July 17, 2009
July 2, 2010
September 2006
April 2010   (final data collection date for primary outcome measure)
IRLS severity scale [ Time Frame: 24 and 48 wks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00942253 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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.

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:

  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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
  • Restless Legs Syndrome
  • End Stage Renal Disease
  • Hemodialysis
  • Muscle Cachexia
  • Sleep Disorders
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.
  • 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.

    Intervention: Other: Dopamine Agonist and 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.

    Intervention: Other: Dopamine Agonist and Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
July 2010
April 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT00942253
3745/EPE/2006, 04EP-07/8.3/04EP-Greece
No
Dr. Giorgos K. Sakkas, University of Thessaly
University of Thessaly
  • Center for Research and Technology Thessaly - CERETETH
  • ENTER - EU Social Fund - General Secretariat for Research and Technology
Principal Investigator: Giorgos K Sakkas, PhD UTH - CERETETH
Study Chair: Ioannis Stefanidis, MD PhD UTH
University of Thessaly
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP