Clinical trial NCT00942253: Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Restless Legs Syndrome
End Stage Renal Disease
Hemodialysis
Muscle Cachexia
Sleep Disorders
Keywords: RLS
Muscle
Dialysis
exercise
dopamine agonist
Sleep
Lead sponsor: University of Thessaly
Sponsor class: OTHER
Collaborators: name: Center for Research and Technology Thessaly - CERETETH
name: European Social Fund
First posted: 2009-07-20
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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.

Primary outcomes:
measure: IRLS severity scale
timeFrame: 24 and 48 wks
Secondary outcomes:
measure: Quality of Life Quality of Sleep Functional Capacity Muscle Size and composition Body Composition Glucose Tolerance Heart and respiratory functionality
timeFrame: 24 and 48 wks
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University Hospital of Larissa, Nephrology Clinic
state: Thessaly
Study officials:
affiliation: UTH - CERETETH
name: Giorgos K Sakkas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UTH
name: Ioannis Stefanidis, MD PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.