Dopamine Transporter Density Profiles in Patients With Periodic Limb Movements (DOPATRANSPLM)

This study has been completed.
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Associação Fundo de Incentivo à Pesquisa
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01365364
First received: May 16, 2011
Last updated: June 2, 2011
Last verified: May 2011
  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

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Other clinical and neurological conditions,
  • continuous pharmacological treatment
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01365364

Locations
Brazil
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
  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
Autonomic Agents
Cardiotonic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014