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Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS) (HDRLS)

Primary Purpose

Restless Legs Syndrome, End Stage Renal Disease, Hemodialysis

Status
Completed
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Dopamine Agonist and Exercise
Sponsored by
University of Thessaly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Restless Legs Syndrome focused on measuring RLS, Muscle, Dialysis, exercise, dopamine agonist, Sleep

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital of Larissa, Nephrology Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dopamine Agonist Group

Placebo Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

IRLS severity scale

Secondary Outcome Measures

Quality of Life Quality of Sleep Functional Capacity Muscle Size and composition Body Composition Glucose Tolerance Heart and respiratory functionality

Full Information

First Posted
July 17, 2009
Last Updated
July 2, 2010
Sponsor
University of Thessaly
Collaborators
Center for Research and Technology Thessaly - CERETETH, European Social Fund
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1. Study Identification

Unique Protocol Identification Number
NCT00942253
Brief Title
Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS)
Acronym
HDRLS
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

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Thessaly
Collaborators
Center for Research and Technology Thessaly - CERETETH, European Social Fund

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome, End Stage Renal Disease, Hemodialysis, Muscle Cachexia, Sleep Disorders
Keywords
RLS, Muscle, Dialysis, exercise, dopamine agonist, Sleep

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dopamine Agonist Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Dopamine Agonist and Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
IRLS severity scale
Time Frame
24 and 48 wks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giorgos K Sakkas, PhD
Organizational Affiliation
UTH - CERETETH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ioannis Stefanidis, MD PhD
Organizational Affiliation
UTH
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital of Larissa, Nephrology Clinic
City
Larissa
State/Province
Thessaly
ZIP/Postal Code
41110
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
35018639
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.
Results Reference
derived
PubMed Identifier
26262586
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.
Results Reference
derived
PubMed Identifier
24024727
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.
Results Reference
derived
PubMed Identifier
23929523
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.
Results Reference
derived

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Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS)

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