An interventional study of Aerobic Physical Exercise and Aerobic Physical Exercise in Periodic Limb Movements in Sleep, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to male participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-03.
Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Health services research
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.
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).
Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Individuals with increased periodic leg movement index (\>5)
Behavioral: Aerobic Physical Exercise
Individuals with PLM index \<5
Behavioral: Aerobic Physical Exercise
All individuals were submitted to physical exercise reaching maximum effort
Also known as: Acute Physical Exercise: Maximal Exercise Test
All individuals were submitted to physical exercise reaching maximum effort
Also known as: Acute Physical Exercise: Maximal Exercise Test
Dopamine Transporter Density Measurement
Dopamine Transporter Density Measurement assessed by SPECT using TRODAT-1
Time frame: Baseline and after 5 hours of exercise effort measurements
Exercise Effort Maximum
Exercise Effort VO2 maximum measurement
Time frame: 1 week after baseline SPECT
This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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Federal University of São Paulo