Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000609257
Ethics application status
Approved
Date submitted
7/07/2009
Date registered
22/07/2009
Date last updated
22/07/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study of possible effects of the association of Ginkgo biloba, omega-3 and physical exercise in memory and executive functions of older people with Parkinson's disease.
Scientific title
A randomised controlled trial evaluating the effects of the association of Ginkgo biloba, omega-3 and physical exercise in memory and executive functions of older people with Parkinson's disease.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 237087 0
Condition category
Condition code
Mental Health 237411 237411 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Extract of Ginkgo biloba, omega-3, physical exercise.
All these interventions will be combined together for the treatment group.
The amount of Gingko biloba and omega-3 to be used, respectively, 80mg and 1g per day in capsules, during six months.
The exercise will envolve coordination, balance, flexibility, strength and aerobic endurance, one hour for sessions, three times a week, during six months.
Intervention code [1] 236806 0
Prevention
Comparator / control treatment
placebo, treatment
Placebo for Ginkgo biloba and omega-3, respectively, talc and liquid paraffin in capsules, taken once a day, during six months.
Control group
Placebo

Outcomes
Primary outcome [1] 238299 0
Executive function with Wisconsin Card Sorting Test (WCST)
Timepoint [1] 238299 0
Measured at baseline and then reapplied after six months to pre-test, to avoid learning effects.
Secondary outcome [1] 244689 0
Cognitive performance.
This outcome will be assessed by questionnaires and tests by the trained professional, pre- and post-intervention with an interval of six months.
Timepoint [1] 244689 0
Six months from baseline.

Eligibility
Key inclusion criteria
Age 60 or older; present clinical diagnosis of Parkinson's disease in the stages from 1 (mild) to 3 (moderate) assessed by the Hoehn and Yahr Scale;not present indication of dementia by results of the Mini-Mental State Examination—MMSE;not be attending any physical exercise program.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who not meet the criteria for inclusion; show allergic reaction to substances and not reach 70% of attendance in training.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The procedure for enrolling will do at Brazil Parkinson Association in Sao Paulo. The 80 participants should be diagnosed with Parkinson's disease. Participants will be encoded and after will be realized the randomization.
Participants do not know which groups will be distributed from the beginning of the evaluations. The testing criteria for inclusion are those that determine which participants will be part of the study.
Allocation was concealed if it was done by numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple Randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 1851 0
Brazil
State/province [1] 1851 0
Sao Paulo
Country [2] 1852 0
Brazil
State/province [2] 1852 0

Funding & Sponsors
Funding source category [1] 237270 0
University
Name [1] 237270 0
Universidade Federal de Sao Paulo
Country [1] 237270 0
Brazil
Funding source category [2] 237271 0
Government body
Name [2] 237271 0
Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior (CAPES)
Country [2] 237271 0
Brazil
Primary sponsor type
University
Name
Universidade Federal de Sao Paulo
Address
Rua Botucatu, 740
Vila Clementino
Sao Paulo - SP
CEP 04023-900
Country
Brazil
Secondary sponsor category [1] 236760 0
Other Collaborative groups
Name [1] 236760 0
Associacao Fundo de Incentivo a Psicofarmacologia (AFIP)
Address [1] 236760 0
Rua Napoleao de Barros, 925
Vila Clementino
Sao Paulo - SP
CEP: 04024-002
Country [1] 236760 0
Brazil
Other collaborator category [1] 747 0
Other Collaborative groups
Name [1] 747 0
Associacao Brasil Parkinson
Address [1] 747 0
Avenida Bosque da Saude, 1155
Sao Paulo - SP
CEP: 04142-080
Brazil
Country [1] 747 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239371 0
Comite de Etica em Pesquisa da Universidade Federal de Sao Paulo / Hospital Sao Paulo
Ethics committee address [1] 239371 0
Ethics committee country [1] 239371 0
Brazil
Date submitted for ethics approval [1] 239371 0
Approval date [1] 239371 0
23/01/2009
Ethics approval number [1] 239371 0
1/09/0028

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29792 0
Address 29792 0
Country 29792 0
Phone 29792 0
Fax 29792 0
Email 29792 0
Contact person for public queries
Name 13039 0
Katia Tanaka
Address 13039 0
Rua Amadeu Luiz Conte, 102
Bosque de Versalles
Araras - SP
CEP: 13609-379
Country 13039 0
Brazil
Phone 13039 0
+55 19 3542 3054 or +55 19 8175 0542
Fax 13039 0
Email 13039 0
katia@psicobio.epm.br
Contact person for scientific queries
Name 3967 0
Katia Tanaka
Address 3967 0
Rua Amadeu Luiz Conte, 102
Bosque de Versalles
Araras - SP
CEP: 13609-379
Country 3967 0
Brazil
Phone 3967 0
+55 19 3542 3054 or +55 19 8175 0542
Fax 3967 0
Email 3967 0
katia@psicobio.epm.br

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.