Periodic Limb Movements in SleepDOPATRANSPLMNCT01365364
Dopamine Transporter Density Profiles in Patients With Periodic Limb Movements
A study testing Aerobic Physical Exercise in people with Periodic Limb Movements in Sleep, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Periodic Limb Movements in Sleep
- What is being tested?
- Aerobic Physical Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- With and without PLM,
- no other health problems,
- sedentary
Who cannot join
- Other clinical and neurological conditions,
- continuous pharmacological treatment
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Estudos em Psicobiologia e Exercicio
São Paulo, São Paulo, 04020-050
About this study
Official title: Dopamine Transporter Density Profiles Assessed by Tc-TRODAT and SPECT 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.
Read the 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).
- Conditions
- Periodic Limb Movements in Sleep
- Being tested
- Aerobic Physical Exercise
- Keywords
- PLM, dopamine, physical exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Physical ExerciseBehavioural
Also called Acute Physical Exercise: Maximal Exercise Test
All individuals were submitted to physical exercise reaching maximum effort
Aerobic Physical ExerciseBehavioural
Also called Acute Physical Exercise: Maximal Exercise Test
All individuals were submitted to physical exercise reaching maximum effort
| Study group | Role | What they receive |
|---|---|---|
| PLM group | Active comparator | Individuals with increased periodic leg movement index (>5) Receives: Behavioral: Aerobic Physical Exercise |
| Non-PLM group | Active comparator | Individuals with PLM index <5 Receives: Behavioral: Aerobic Physical Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dopamine Transporter Density Measurement
Dopamine Transporter Density Measurement assessed by SPECT using TRODAT-1
Measured: Baseline and after 5 hours of exercise effort measurements
Secondary outcomes (1)
Exercise Effort Maximum
Exercise Effort VO2 maximum measurement
Measured: 1 week after baseline SPECT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startMar 2009
- Primary completionOct 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Periodic Limb Movements in SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Associação Fundo de Incentivo à Pesquisa
- Investigators
- Marco Tulio Mello, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365364
- Sponsor's protocol ID
- CEP0546/08
- Acronym
- DOPATRANSPLM
- Status last verified
- May 2011
- First submitted
- 16 May 2011
- Last updated
- 3 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21358851Mrowka 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.
PubMed 15517434Wetter 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.
PubMed 15223000
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopamine Transporter Density Profiles Assessed by Tc-TRODAT and SPECT in Patients With Periodic Limb Movements
- ClinicalTrials.gov ID
- NCT01365364
- Acronym / sponsor ID
- DOPATRANSPLM / CEP0546/08
- Conditions
- Periodic Limb Movements in Sleep
- Keywords
- PLM, dopamine, physical exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Associação Fundo de Incentivo à Pesquisa
- Study start
- Mar 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLM group | Active comparator | Behavioral: Aerobic Physical ExerciseIndividuals with increased periodic leg movement index (>5) |
| Non-PLM group | Active comparator | Behavioral: Aerobic Physical ExerciseIndividuals with PLM index <5 |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- With and without PLM,
- no other health problems,
- sedentary
Key exclusion criteria (2 listed)
- Other clinical and neurological conditions,
- continuous pharmacological treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Physical ExerciseAlso: Acute Physical Exercise: Maximal Exercise TestAll individuals were submitted to physical exercise reaching maximum effort | Behavioural | PLM group |
| Aerobic Physical ExerciseAlso: Acute Physical Exercise: Maximal Exercise TestAll individuals were submitted to physical exercise reaching maximum effort | Behavioural | Non-PLM group, PLM group |
Primary outcome
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
1 secondary outcome
Exercise Effort Maximum
Time frame: 1 week after baseline SPECT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2011.
- Results publication: PubMed 21358851Earley 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.
- Results publication: PubMed 15517434Mrowka 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.
- Results publication: PubMed 15223000Wetter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Tulio Mello, PhD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Physical Exercise in people with Periodic Limb Movements in Sleep, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dopamine Transporter Density Measurement (time frame: Baseline and after 5 hours of exercise effort measurements). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01365364, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2011.