Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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.
Query!
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.
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease
237087
0
Query!
Condition category
Condition code
Mental Health
237411
237411
0
0
Query!
Studies of normal psychology, cognitive function and behaviour
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
236806
0
Prevention
Query!
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.
Query!
Control group
Placebo
Query!
Outcomes
Primary outcome [1]
238299
0
Executive function with Wisconsin Card Sorting Test (WCST)
Query!
Assessment method [1]
238299
0
Query!
Timepoint [1]
238299
0
Measured at baseline and then reapplied after six months to pre-test, to avoid learning effects.
Query!
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.
Query!
Assessment method [1]
244689
0
Query!
Timepoint [1]
244689
0
Six months from baseline.
Query!
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.
Query!
Minimum age
60
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Those who not meet the criteria for inclusion; show allergic reaction to substances and not reach 70% of attendance in training.
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
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
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple Randomization
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Safety/efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
1/06/2009
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
80
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
1851
0
Brazil
Query!
State/province [1]
1851
0
Sao Paulo
Query!
Country [2]
1852
0
Brazil
Query!
State/province [2]
1852
0
Query!
Funding & Sponsors
Funding source category [1]
237270
0
University
Query!
Name [1]
237270
0
Universidade Federal de Sao Paulo
Query!
Address [1]
237270
0
Rua Botucatu, 740
Vila Clementino
Sao Paulo - SP
CEP 04023-900
Query!
Country [1]
237270
0
Brazil
Query!
Funding source category [2]
237271
0
Government body
Query!
Name [2]
237271
0
Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior (CAPES)
Query!
Address [2]
237271
0
Caixa Postal: 250
Second floor
Ministerio da Educacao
Brasilia - DF
CEP: 70359-970
Query!
Country [2]
237271
0
Brazil
Query!
Primary sponsor type
University
Query!
Name
Universidade Federal de Sao Paulo
Query!
Address
Rua Botucatu, 740
Vila Clementino
Sao Paulo - SP
CEP 04023-900
Query!
Country
Brazil
Query!
Secondary sponsor category [1]
236760
0
Other Collaborative groups
Query!
Name [1]
236760
0
Associacao Fundo de Incentivo a Psicofarmacologia (AFIP)
Query!
Address [1]
236760
0
Rua Napoleao de Barros, 925
Vila Clementino
Sao Paulo - SP
CEP: 04024-002
Query!
Country [1]
236760
0
Brazil
Query!
Other collaborator category [1]
747
0
Other Collaborative groups
Query!
Name [1]
747
0
Associacao Brasil Parkinson
Query!
Address [1]
747
0
Avenida Bosque da Saude, 1155
Sao Paulo - SP
CEP: 04142-080
Brazil
Query!
Country [1]
747
0
Brazil
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
239371
0
Comite de Etica em Pesquisa da Universidade Federal de Sao Paulo / Hospital Sao Paulo
Query!
Ethics committee address [1]
239371
0
Rua Botucatu, 572 - first floor conj 14
Vila Clementino
Sao Paulo - SP
CEP:04023-061
Query!
Ethics committee country [1]
239371
0
Brazil
Query!
Date submitted for ethics approval [1]
239371
0
Query!
Approval date [1]
239371
0
23/01/2009
Query!
Ethics approval number [1]
239371
0
1/09/0028
Query!
Summary
Brief summary
Parkinson's disease can cause cognitive decline. Although the exact cause of neuronal loss in Parkinson's disease remains unknown, current evidence points to the presence of ongoing oxidative stress. The physical exercise can benefit the cognitive function in older people with Parkinson's disease. Ginkgo biloba and omega-3 has been reported to be an antioxidative agent and neuroprotective. We suspect that the combination of the three may potentiate the effect.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
29792
0
Query!
Address
29792
0
Query!
Country
29792
0
Query!
Phone
29792
0
Query!
Fax
29792
0
Query!
Email
29792
0
Query!
Contact person for public queries
Name
13039
0
Katia Tanaka
Query!
Address
13039
0
Rua Amadeu Luiz Conte, 102
Bosque de Versalles
Araras - SP
CEP: 13609-379
Query!
Country
13039
0
Brazil
Query!
Phone
13039
0
+55 19 3542 3054 or +55 19 8175 0542
Query!
Fax
13039
0
Query!
Email
13039
0
[email protected]
Query!
Contact person for scientific queries
Name
3967
0
Katia Tanaka
Query!
Address
3967
0
Rua Amadeu Luiz Conte, 102
Bosque de Versalles
Araras - SP
CEP: 13609-379
Query!
Country
3967
0
Brazil
Query!
Phone
3967
0
+55 19 3542 3054 or +55 19 8175 0542
Query!
Fax
3967
0
Query!
Email
3967
0
[email protected]
Query!
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.
Download to PDF