Skip to main content
OpenTrials
Completed

NCT Number: NCT01365364

Dopamine Transporter Density Profiles in Patients With Periodic Limb Movements

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

45 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Estudos em Psicobiologia e Exercicio

São Paulo, 04020-050, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • With and without PLM,
  • no other health problems,
  • sedentary

Exclusion criteria

  • Other clinical and neurological conditions,
  • continuous pharmacological treatment

Treatment and study plan

Aerobic Physical Exercise

Behavioral

All individuals were submitted to physical exercise reaching maximum effort

Other names: Acute Physical Exercise: Maximal Exercise Test

Primary outcomes

  1. Dopamine Transporter Density Measurement

    Time frame: Baseline and after 5 hours of exercise effort measurements

    Dopamine Transporter Density Measurement assessed by SPECT using TRODAT-1

Secondary outcomes

  1. Exercise Effort Maximum

    Time frame: 1 week after baseline SPECT

    Exercise Effort VO2 maximum measurement

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Associação Fundo de Incentivo à Pesquisa
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Acronym: DOPATRANSPLM

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 3, 2011
Registry last updated
Jun 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.