close help
scroll up   scroll up
Australian New Zealand Clinical Trials Registry
Home Login Contact us Feedback
Australian New Zealand Clinical Trials Registry
Register Trial Trial Search Latest News FAQ About ANZCTR
ANZCTR Newsletter Issue 5, Dec 2009 National and multinational prospective trial registers - The Lancet commentary En route to international clinical trial transparency - The Lancet commentary Declaration of Helsinki now has trial registration requirement (paragraph 19) The 2007 National Health and Medical Research Council (NHMRC) revised National Statement on Ethical Conduct in Human Research includes clause regarding trial registration (page 36, section 3.3.12) The 2007 NHMRC Australian Code for the Responsible Conduct of Research includes a clause regarding trial registration (section 4.10). This Code applies to all NHMRC funded trials The National Ethics Application Form (NEAF) now includes a question regarding details of trial registration (Question 9.1.8.4) ICMJE expands scope of registration ANZCTR is one of the first Primary Registers in the WHO Register Network (Search Portal)
ANZCTR User Survey ANZCTR Statistics International Committee of Medical Journal Editors (ICMJE): June 2007 editorial International Committee of Medical Journal Editors (ICMJE): May 2005 editorial WHO International Clinical Trials Registry Platform (ICTRP) The World Health Organization announces new standards for registration of all human medical research WHO trial registration data set NHMRC Clinical Trials Centre National Health and Medical Research Council (NHMRC) information about the ANZCTR Frequently Asked Questions about the ANZCTR About the ANZCTR How to register a trial How to update a trial

Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 000112
ACTR Number: ACTRN12605000136606
Trial Status: Registered
Date Submitted: 2/08/2005
Date Registered: 12/08/2005

Page 1

Public title: A randomised clinical trial of physical activity for the treatment of older adults with mild cognitive impairment
ANZCTR registration title: A randomised clinical trial to evaluate the effect of physical activity on cognition and quality of life in the conditons subjective memory complaints, mild cognitive impairment and Alzheimer's disease.
Secondary ID: 
UTN:
Trial acronym:

Page 2

Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 
Subjective Memory Complaints 
Alzheimer's Disease 
Condition category: Condition code:
Neurological Dementias 
Neurological Neurodegenerative diseases 
Neurological Alzheimer's disease 

Page 3

Description of intervention(s) / exposure: The active group receive a 6-month physical activity program.
Intervention code:None 
Comparator / control treatment: The active and the control group receive educational material on cognitive impairment in older age and recommendations for a healthy lifestyle.
Control group: Active

Page 4

Primary outcome:Cognitive decline. 
Timepoint:For participants with Alzheimer's disease the primary outcome will be measured 6 months after enrolment. For participants with subjective memory complaints or mild cognitive impairment the primary outcome will be measured 18 months after enrolment. 
Secondary outcome 1:For participants with Alzheimer's disease the secondary outcome: quality of life. 
Timepoint:Measured at 6 months after enrolment. 
Secondary outcome 2:For participants with Mild Cognitive impairment the secondary outcome: diagnosis of dementia and quality of life. 
Timepoint:Measured 18 months after enrolment. 

Page 5

Key inclusion criteria: Diagnosis of Mild Cognitive Impairment, subjective Memoery Complaints or mild to moderate Alzheimer's disease.
Minimum Age: Not stated
Maximum Age: Not stated
Gender: Both males and females
Healthy volunteers? No
Key exclusion criteria: Clinical history of stroke, unstable or life threatening illness.

Page 6
Study type: Interventional
Purpose of the study: Prevention
Allocation to intervention: Randomised controlled trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): Sealed envelopes are used.
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation): Randomisation occurred in blocks. Sequence generation was performed consecutively selecting one of the identical cards from the block.
Masking / blinding: Blinded (masking used)
Who is/are masked/blinded:
Assignment: Parallel
Other design features (specify):
Type of endpoint(s): Efficacy

Page 7
Phase
Anticipated or actual start date: 22/04/2004
Target sample size: 168
Recruitment status: Closed: follow-up continuing

Page 8

Funding source:Government funding body e.g. Australian Research Council 
Name:NHMRC 
Address: 
Country:Australia 
Primary sponsor: Government funding body e.g. Department of Health
Name: NHMRC
Address:
Country: Australia
Secondary sponsor:Charities/Societies/Foundations 
Name:Rotary Australia 
Address: 
Country:Australia 
Other collaborator: 

Page 9

Has the study received approval from at least one ethics committee? Yes
Ethics Committee: 
Countries of recruitment:Australia 
Brief summary:
Trial website:
Presentations / publication list:

Page 10

Contact person for public queries
Name: A/Prof N Lautenschlager
Address: School of Psychiatry and Clinical Neurosciences University of Western Australia M 573 35 Stirling Highway Crawley WA 6009
Country: Australia
Tel: +61 8 92242855
Fax:
Email: nicolal@cyllene.uwa.edu.au

Contact person for scientific queries
Name: A/Prof N Lautenschlager
Address: School of Psychiatry and Clinical Neurosciences University of Western Australia M 573 35 Stirling Highway Crawley WA 6009
Country: Australia
Tel: +61 8 92242855
Fax:
Email: nicolal@cyllene.uwa.edu.au

Contact person responsible for updating information
Name:
Address:
Country:
Tel:
Fax:
Email:
   
© 2007 ANZCTR Terms and Conditions Privacy      Design by Symbiation