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

University of Thessaly

Status and phase: Completed; Phase 2

Conditions: Sleep Disorders; Hemodialysis; End Stage Renal Disease; Restless Legs Syndrome; Muscle Cachexia

Treatments: Other: Dopamine Agonist and Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT00942253

3745/EPE/2006

04EP-07/8.3/04EP-Greece

Details and patient eligibility

About

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.

Full 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

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 2 patient groups, including a placebo group

Dopamine Agonist Group

Experimental group

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.

Treatment:

Other: Dopamine Agonist and Exercise

Placebo Group

Placebo Comparator group

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.

Treatment:

Other: Dopamine Agonist and Exercise