Dopamine Transporter Density Profiles in Patients With Periodic Limb Movements (DOPATRANSPLM)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Periodic Limb Movements in Sleep |
Behavioral: Aerobic Physical Exercise |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Dopamine Transporter Density Profiles Assessed by Tc-TRODAT and SPECT in Patients With Periodic Limb Movements |
- Dopamine Transporter Density Measurement [ Time Frame: Baseline and after 5 hours of exercise effort measurements ] [ Designated as safety issue: Yes ]Dopamine Transporter Density Measurement assessed by SPECT using TRODAT-1
- Exercise Effort Maximum [ Time Frame: 1 week after baseline SPECT ] [ Designated as safety issue: Yes ]Exercise Effort VO2 maximum measurement
| Enrollment: | 16 |
| Study Start Date: | March 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: PLM group
Individuals with increased periodic leg movement index (>5)
|
Behavioral: Aerobic Physical Exercise
All individuals were submitted to physical exercise reaching maximum effort
Other Name: Acute Physical Exercise: Maximal Exercise Test
Behavioral: Aerobic Physical Exercise
All individuals were submitted to physical exercise reaching maximum effort
Other Name: Acute Physical Exercise: Maximal Exercise Test
|
|
Active Comparator: Non-PLM group
Individuals with PLM index <5
|
Behavioral: Aerobic Physical Exercise
All individuals were submitted to physical exercise reaching maximum effort
Other Name: Acute Physical Exercise: Maximal Exercise Test
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 45 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- With and without PLM,
- no other health problems,
- sedentary
Exclusion Criteria:
- Other clinical and neurological conditions,
- continuous pharmacological treatment
Contacts and Locations| Brazil | |
| Centro de Estudos em Psicobiologia e Exercicio | |
| São Paulo, Brazil, 04020-050 | |
| Principal Investigator: | Marco Tulio Mello, PhD | Federal University of São Paulo |
More Information
Publications:
| Responsible Party: | Marco Tulio de Mello, Federal University of São Paulo |
| ClinicalTrials.gov Identifier: | NCT01365364 History of Changes |
| Other Study ID Numbers: | CEP0546/08 |
| Study First Received: | May 16, 2011 |
| Last Updated: | June 2, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Federal University of São Paulo:
|
PLM dopamine physical exercise |
Additional relevant MeSH terms:
|
Dopamine Dopamine Agents Cardiotonic Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympathomimetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 21, 2013