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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00942253
Study type	Interventional
Source	University of Thessaly
Contact
Status	Completed
Phase	Phase 2
Start date	September 2006
Completion date	July 2010

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04076488` - Feasibility of an Interactive Tablet-based Exercise Program for People With Chronical Diseases	N/A
Completed	`NCT03289650` - Extended Release Tacrolimus vs. Twice-Daily Tacrolimus	Phase 3
Completed	`NCT04042324` - A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients	Phase 1/Phase 2
Completed	`NCT01242904` - Use of a Bimodal Solution for Peritoneal Dialysis	Phase 2
Active, not recruiting	`NCT03183245` - Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis	Phase 3
Completed	`NCT03257410` - Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients	N/A
Completed	`NCT03627299` - Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors	Phase 4
Recruiting	`NCT05917795` - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates	N/A
Terminated	`NCT03539861` - Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients	N/A
Withdrawn	`NCT02130817` - Belatacept in Kidney Transplantation of Moderately Sensitized Patients	Phase 4
Completed	`NCT05540457` - Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis)	N/A
Not yet recruiting	`NCT04900610` - The Effect of Vitamin K2 Supplementation on Arterial Stifness and Cardiovascular Events in PEritonial DIAlysis	N/A
Recruiting	`NCT02176434` - Pilot Feasibility Study of Combined Kidney and Hematopoietic Stem Cell Transplantation to Cure End-stage Renal Disease	N/A
Active, not recruiting	`NCT02581449` - Effect of Omega-3 Fatty Acids on Oxidative Stress and Dyslipidemia in Pediatric Patients Undergoing Hemodialysis	Phase 2
Completed	`NCT02830490` - Reliability of Functional Measures in Hemodialysis Patient.	N/A
Completed	`NCT02832466` - Quantifying the Deterioration of Physical Function in Renal Patients	N/A
Completed	`NCT02134314` - C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI	Phase 1/Phase 2
Completed	`NCT02215655` - Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence	N/A
Completed	`NCT02832440` - Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis	N/A
Recruiting	`NCT01912001` - Virtual Ward for Home Dialysis	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms