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| ID | Type | Description | Link |
|---|---|---|---|
| 04EP-07/8.3/04EP-Greece |
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| Name | Class |
|---|---|
| Center for Research and Technology Thessaly - CERETETH | UNKNOWN |
| European Social Fund | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dopamine Agonist Group | Experimental | 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. |
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| Placebo Group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dopamine Agonist and Exercise | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| IRLS severity scale | 24 and 48 wks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Quality of Sleep Functional Capacity Muscle Size and composition Body Composition Glucose Tolerance Heart and respiratory functionality | 24 and 48 wks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giorgos K Sakkas, PhD | UTH - CERETETH | Principal Investigator |
| Ioannis Stefanidis, MD PhD | UTH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Larissa, Nephrology Clinic | Larissa | Thessaly | 41110 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35018639 | Derived | Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653. | |
| 26262586 | Derived | Giannaki CD, Sakkas GK, Karatzaferi C, Maridaki MD, Koutedakis Y, Hadjigeorgiou GM, Stefanidis I. Combination of Exercise Training and Dopamine Agonists in Patients with RLS on Dialysis: A Randomized, Double-Blind Placebo-Controlled Study. ASAIO J. 2015 Nov-Dec;61(6):738-41. doi: 10.1097/MAT.0000000000000271. |
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| D007676 | Kidney Failure, Chronic |
| D012893 | Sleep Wake Disorders |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D020447 | Parasomnias |
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| ID | Term |
|---|---|
| D018491 | Dopamine Agonists |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D015259 | Dopamine Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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| 24024727 | Derived | Giannaki CD, Sakkas GK, Karatzaferi C, Hadjigeorgiou GM, Lavdas E, Kyriakides T, Koutedakis Y, Stefanidis I. Effect of exercise training and dopamine agonists in patients with uremic restless legs syndrome: a six-month randomized, partially double-blind, placebo-controlled comparative study. BMC Nephrol. 2013 Sep 11;14:194. doi: 10.1186/1471-2369-14-194. |
| 23929523 | Derived | Giannaki CD, Hadjigeorgiou GM, Karatzaferi C, Maridaki MD, Koutedakis Y, Founta P, Tsianas N, Stefanidis I, Sakkas GK. A single-blind randomized controlled trial to evaluate the effect of 6 months of progressive aerobic exercise training in patients with uraemic restless legs syndrome. Nephrol Dial Transplant. 2013 Nov;28(11):2834-40. doi: 10.1093/ndt/gft288. Epub 2013 Aug 8. |
| D001523 |
| Mental Disorders |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |