Dopamine Transporter Density Profiles in Patients With Periodic Limb Movements

NCT01365364 | Completed DMC

• 1 other identifier: CEP0546/08
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodic Limb Movements in Sleep

Keywords

PLM; dopamine; physical exercise

Outcome Measures

Primary Outcomes (1)

• Dopamine Transporter Density Measurement

  Dopamine Transporter Density Measurement assessed by SPECT using TRODAT-1

  Baseline and after 5 hours of exercise effort measurements

Secondary Outcomes (1)

• Exercise Effort Maximum

  1 week after baseline SPECT

Study Arms (2)

PLM group

ACTIVE COMPARATOR

Individuals with increased periodic leg movement index (\>5)

Behavioral: Aerobic Physical Exercise

Non-PLM group

ACTIVE COMPARATOR

Individuals with PLM index \<5

Behavioral: Aerobic Physical Exercise

Interventions

Aerobic Physical Exercise BEHAVIORAL

All individuals were submitted to physical exercise reaching maximum effort

Also known as: Acute Physical Exercise: Maximal Exercise Test

PLM group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Other clinical and neurological conditions,
• continuous pharmacological treatment

Sponsors & Collaborators

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

Study Sites (1)

Centro de Estudos em Psicobiologia e Exercicio

São Paulo, São Paulo, 04020-050, Brazil

Location

Related Publications (3)

• Earley CJ, Kuwabara H, Wong DF, Gamaldo C, Salas R, Brasic J, Ravert HT, Dannals RF, Allen RP. The dopamine transporter is decreased in the striatum of subjects with restless legs syndrome. Sleep. 2011 Mar 1;34(3):341-7. doi: 10.1093/sleep/34.3.341.

  PMID: 21358851 RESULT

• Mrowka M, Jobges M, Berding G, Schimke N, Shing M, Odin P. Computerized movement analysis and beta-CIT-SPECT in patients with restless legs syndrome. J Neural Transm (Vienna). 2005 May;112(5):693-701. doi: 10.1007/s00702-004-0217-9. Epub 2004 Oct 27.

  PMID: 15517434 RESULT

• Wetter TC, Eisensehr I, Trenkwalder C. Functional neuroimaging studies in restless legs syndrome. Sleep Med. 2004 Jul;5(4):401-6. doi: 10.1016/j.sleep.2004.01.009.

  PMID: 15223000 RESULT

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marco Tulio Mello, PhD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: June 3, 2011
• Study Start: March 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 3, 2011

Record last verified: 2011-05

Locations

BR (1)