title: 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.
abstract: BACKGROUND
  Restless Legs Syndrome is very common in hemodialysis patients however there are no comparative studies assessing the effectiveness of a non-pharmacological treatment to a classical treatment on parameters related to syndromes' severity and quality of life.
  
  
  METHODS
  In this randomized, partially double blind, placebo controlled trial, thirty two hemodialysis patients with restless legs syndrome were randomly assigned into three groups: 1) the exercise training group (N = 16), 2) the dopamine agonists group (ropinirole 0.25 mg/d) (N = 8) and 3) the placebo group (N = 8). The intervention programs lasted 6 months. Restless Legs Syndrome severity was assessed using the international severity scale, physical performance by a battery of tests, muscle size and composition by computed tomography, body composition by Dual Energy X Ray Absorptiometry, while depression score, sleep quality, daily sleepiness and quality of life were assessed through questionnaires.
  
  
  RESULTS
  Exercise training and dopamine agonists were effective in reducing syndrome's symptoms by 46% (P = 0.009) and 54% (P = 0.001) respectively. Within group changes revealed that both approaches significantly improved quality of life (P < 0.05), however, only the dopamine agonists significantly improved sleep quality (P = 0.009). Within group changes showed a tendency for lean body mass improvements with dopamine agonists, this reached statistical significance only with the exercise training (P = 0.014), which also reduced fat infiltration in muscles (P = 0.044) and improved physical performance (P > 0.05) in various tests. Between group changes detect significant improvements with both exercise and dopamine agonists in depression score (P = 0.003), while only the dopamine agonist treatment was able to significantly improve sleep quality, compared to exercise and placebo (P = 0.016).
  
  
  CONCLUSIONS
  A 6-month exercise training regime was as effective as a 6-month low dosage dopamine agonist treatment in reducing restless legs syndrome symptoms and improving depression score in uremic patients. Further research is needed in order to show whether a combination treatment could be more beneficial for the amelioration of RLS.
  
  
  BACKGROUND
  NCT00942253.
authors.affiliation: Department of Nephrology, School of Medicine, University of Thessaly, Larissa, Greece. gsakkas@med.uth.gr.
authors.forename: Christoforos D
authors.initials: CD
authors.lastname: Giannaki
authors.forename: Giorgos K
authors.initials: GK
authors.lastname: Sakkas
authors.forename: Christina
authors.initials: C
authors.lastname: Karatzaferi
authors.forename: Georgios M
authors.initials: GM
authors.lastname: Hadjigeorgiou
authors.forename: Eleftherios
authors.initials: E
authors.lastname: Lavdas
authors.forename: Theodoros
authors.initials: T
authors.lastname: Kyriakides
authors.forename: Yiannis
authors.initials: Y
authors.lastname: Koutedakis
authors.forename: Ioannis
authors.initials: I
authors.lastname: Stefanidis
mesh_terms: D003131:Combined Modality Therapy / Q000379:methods; D018491:Dopamine Agonists / Q000627:therapeutic use*; D004311:Double-Blind Method; D005081:Exercise Therapy; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D015990:Placebo Effect; D011788:Quality of Life / Q000523:psychology; D006435:Renal Dialysis / Q000009:adverse effects*; D012148:Restless Legs Syndrome / Q000209:etiology* / Q000517:prevention & control* / Q000523:psychology; D016896:Treatment Outcome; D014511:Uremia / Q000150:complications* / Q000523:psychology / Q000628:therapy
chemical_list: D018491:Dopamine Agonists
references.citation: Diabetes Obes Metab. 2004 Jul;6(4):239-48
references.pmid: 15171747
references.citation: Hemodial Int. 2008 Jan;12(1):6-15
references.pmid: 18271834
references.citation: Cereb Cortex. 2008 Nov;18(11):2523-31
references.pmid: 18296435
references.citation: Clin J Am Soc Nephrol. 2006 May;1(3):349-52
references.pmid: 17699229
references.citation: Nephrol Dial Transplant. 2008 Aug;23(8):2461-6
references.pmid: 18390566
references.citation: Sports Med. 2005;35(6):485-99
references.pmid: 15974634
references.citation: J Clin Endocrinol Metab. 2003 Apr;88(4):1785-91
references.pmid: 12679474
references.citation: Sleep Med. 2004 May;5(3):309-15
references.pmid: 15165541
references.citation: Brain. 2005 Apr;128(Pt 4):906-17
references.pmid: 15728657
references.citation: Arch Gen Psychiatry. 1965 Jan;12:63-70
references.pmid: 14221692
references.citation: Sleep. 1995 Oct;18(8):681-8
references.pmid: 8560135
references.citation: Semin Dial. 2000 Jan-Feb;13(1):4-8
references.pmid: 10740665
references.citation: Brain. 2008 Apr;131(Pt 4):902-17
references.pmid: 17932100
references.citation: J Neurol Sci. 2009 Apr 15;279(1-2):62-5
references.pmid: 19167016
references.citation: Adv Chronic Kidney Dis. 2009 Nov;16(6):501-10
references.pmid: 19801138
references.citation: Nephrol Dial Transplant. 2003 Oct;18(10):2074-81
references.pmid: 13679483
references.citation: Am J Kidney Dis. 2006 May;47(5):862-9
references.pmid: 16632026
references.citation: Sleep Med. 2003 Mar;4(2):101-19
references.pmid: 14592341
references.citation: Clin Infect Dis. 2004 Sep 1;39(5):732-5
references.pmid: 15356790
references.citation: ASAIO J. 2010 Nov-Dec;56(6):538-42
references.pmid: 21245801
references.citation: J Am Board Fam Med. 2006 Sep-Oct;19(5):487-93
references.pmid: 16951298
references.citation: Mov Disord. 2007;22 Suppl 18:S476-84
references.pmid: 17580331
references.citation: J Am Soc Nephrol. 2006 Aug;17(8):2307-14
references.pmid: 16825332
references.citation: J Appl Physiol (1985). 2005 Sep;99(3):1220-5
references.pmid: 15860689
references.citation: ASAIO J. 2008 Mar-Apr;54(2):185-90
references.pmid: 18356653
references.citation: Sleep Med. 2003 Mar;4(2):121-32
references.pmid: 14592342
references.citation: Med Sci Sports Exerc. 2009 Jan;41(1):237-42
references.pmid: 19092683
references.citation: Am J Physiol Regul Integr Comp Physiol. 2008 Dec;295(6):R1721-9
references.pmid: 18832089
references.citation: Clin Nephrol. 2006 Dec;66(6):440-6
references.pmid: 17176916
references.citation: J Am Soc Nephrol. 2001 Dec;12(12):2797-2806
references.pmid: 11729250
references.citation: Lancet. 1998 Mar 21;351(9106):867-70
references.pmid: 9525364
references.citation: PLoS One. 2011;6(10):e25180
references.pmid: 21984901
references.citation: Nephrol Dial Transplant. 1998 Aug;13(8):2023-6
references.pmid: 9719158
references.citation: Adv Chronic Kidney Dis. 2009 Nov;16(6):410-9
references.pmid: 19801131
references.citation: Mov Disord. 2003 Oct;18(10):1108-14
references.pmid: 14534913
references.citation: Clin Neuropharmacol. 2004 Jul-Aug;27(4):178-81
references.pmid: 15319704
references.citation: Adv Chronic Kidney Dis. 2007 Jan;14(1):82-99
references.pmid: 17200048
references.citation: Mov Disord. 2001 Nov;16(6):1105-9
references.pmid: 11748742
references.citation: Mov Disord. 2008 Dec 15;23(16):2267-302
references.pmid: 18925578
references.citation: J Psychopharmacol. 2006 Nov;20(6):756-70
references.pmid: 16401653
references.citation: Sleep Med. 2011 Jan;12(1):34-40
references.pmid: 20965780
references.citation: J Am Soc Nephrol. 1993 Nov;4(5):1205-13
references.pmid: 8305648
references.citation: Sleep. 1991 Dec;14(6):540-5
references.pmid: 1798888
references.citation: Mov Disord. 2006 Oct;21(10):1627-35
references.pmid: 16874755
references.citation: Nephrol Dial Transplant. 2003 Sep;18(9):1854-61
references.pmid: 12937235