DOPATRANSPLM: Dopamine Transporter Density Profiles in Patients With Periodic Limb Movements

• Sponsor: Federal University of São Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT01365364
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo (Other), Associação Fundo de Incentivo à Pesquisa (Other)
• Enrollment: 16
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Periodic Limb Movements in Sleep	Behavioral: Aerobic Physical Exercise; Behavioral: Aerobic Physical Exercise	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Acute Physical Exercise: Maximal Exercise Test ; Behavioral: Aerobic Physical Exercise; All individuals were submitted to physical exercise reaching maximum effort; Other Names: 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 Names: Acute Physical Exercise: Maximal Exercise Test

Outcome Measures

Primary Outcome Measures

1. Dopamine Transporter Density Measurement [Baseline and after 5 hours of exercise effort measurements]

   Dopamine Transporter Density Measurement assessed by SPECT using TRODAT-1

Secondary Outcome Measures

1. Exercise Effort Maximum [1 week after baseline SPECT]

   Exercise Effort VO2 maximum measurement

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 65 Years
• Sexes 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

Locations

	Site	City	State	Country	Postal Code
1	Centro de Estudos em Psicobiologia e Exercicio	São Paulo		Brazil	04020-050

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Marco Tulio Mello, PhD, Federal University of São Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01365364
• Other Study ID Numbers: CEP0546/08
• First Posted: Jun 3, 2011
• Last Update Posted: Jun 3, 2011
• Last Verified: May 1, 2011

• Keywords provided by , ,: PLM; dopamine; physical exercise

Study Results

No Results Posted as of Jun 3, 2011