Dopamine Transporter Density Profiles in Patients With Periodic Limb Movements

Study Overview
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Brief Summary
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Restless legs syndrome and periodic limb movement (PLM)are sleep-related movement disorders and studies have shown changes in striatal dopaminergic activity in patients with these disorders. Physical exercise has been shown to improve the symptoms of restless legs syndrome and PLM, as has treatment with dopamine agonists. However, the mechanism by which physical exercise acts as a non-pharmacological treatment in improving symptoms of restless legs syndrome and PLM remains unknown. The investigators evaluated dopamine transporter density profiles in 16 sedentary patients (control and experimental - with PLM, groups) and the influence of acute physical exercise on its concentration after a maximal exercise test. Each patient underwent baseline polysomnography to evaluate sleep patterns and PLM index values. After obtaining the polysomnography baseline, the single photon emission computer tomography baseline was determined. Subsequently, the volunteers performed a maximal exercise test in the morning, followed by a single photon emission computer tomography two hours later and polysomnography that night, to assess the effect of acute physical exercise on dopamine transporter and sleep patterns. The results showed significant lower dopamine transporter baseline densities in the striatum region for the experimental group. The results also showed a significant reduction in the periodic leg movement rate in the experimental group and a significant increased percentage of stage-1 non-REM sleep in both groups after maximal exercise test. Significant differences between the groups were only observed for Stage 2 sleep and slow wave sleep. Our results show that patients with PLM had a lower dopamine transporter density in the left putamen region compared to the control group and an acute physical exercise (maximal exercise test) did not alter this profile, providing evidence that this improvement is the result of chronic physical exercise.

Detailed Description
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Experimental Design Each volunteer (in both control and experimental groups) underwent Polysomnography (PSG) adaptation. After one week, a baseline cerebral SPECT was performed (1-3pm) and a baseline PSG was performed that night to evaluate the sleep pattern and the PLM index. Subsequently (after one week), each subject underwent a maximal exercise test (MET) in the morning (11am to 1pm) after which SPECT examination was performed in the afternoon (1-3 pm). A PSG was then performed that night to evaluate the effect of acute exercise on DAT density and sleep pattern (Figure 1).

Official Title
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Dopamine Transporter Density Profiles Assessed by Tc-TRODAT and SPECT in Patients With Periodic Limb Movements

Conditions
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Periodic Limb Movements in Sleep

Intervention / Treatment
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* Behavioral: Aerobic Physical Exercise
* Behavioral: Aerobic Physical Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: With and without PLM, no other health problems, sedentary Exclusion Criteria: Other clinical and neurological conditions, continuous pharmacological treatment

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PLM group<br>Individuals with increased periodic leg movement index (>5) | Behavioral: Aerobic Physical Exercise<br>* All individuals were submitted to physical exercise reaching maximum effort<br>* Other names: Acute Physical Exercise: Maximal Exercise Test;Behavioral: Aerobic Physical Exercise<br>* All individuals were submitted to physical exercise reaching maximum effort<br>* Other names: Acute Physical Exercise: Maximal Exercise Test;|
| Active Comparator: Non-PLM group<br>Individuals with PLM index <5 | Behavioral: Aerobic Physical Exercise<br>* All individuals were submitted to physical exercise reaching maximum effort<br>* Other names: Acute Physical Exercise: Maximal Exercise Test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dopamine Transporter Density Measurement | Dopamine Transporter Density Measurement assessed by SPECT using TRODAT-1 | Baseline and after 5 hours of exercise effort measurements | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Effort Maximum | Exercise Effort VO2 maximum measurement | 1 week after baseline SPECT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PLM, dopamine, physical exercise