Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS) (HDRLS)
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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. |
- IRLS severity scale [ Time Frame: 24 and 48 wks ] [ Designated as safety issue: Yes ]
- 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:
- 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
- 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
- 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 |
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| Greece | |
| University Hospital of Larissa, Nephrology Clinic | |
| Larissa, Thessaly, Greece, 41110 | |
| Principal Investigator: | Giorgos K Sakkas, PhD | UTH - CERETETH |
| Study Chair: | Ioannis Stefanidis, MD PhD | UTH |
More Information
No publications provided
| 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:
|
Cachexia Kidney Diseases Kidney Failure, Chronic Restless Legs Syndrome Sleep Disorders Parasomnias Psychomotor Agitation Emaciation Weight Loss Body Weight Changes Body Weight Signs and Symptoms Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |
Sleep Disorders, Intrinsic Dyssomnias Nervous System Diseases Mental Disorders Neurologic Manifestations Dyskinesias Psychomotor Disorders Neurobehavioral Manifestations Dopamine Dopamine Agents Dopamine Agonists Cardiotonic Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013