Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000044628
Ethics application status
Approved
Date submitted
25/07/2005
Date registered
26/07/2005
Date last updated
7/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does an enhanced exercise and cognitive program reduce incident delirium?
Scientific title
Does an enhanced exercise and cognitive program reduce incident delirium?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium 110 0
Condition category
Condition code
Neurological 129 129 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twice daily progressive exercise program and orientation protocol for the duration of hospital admission.
Intervention code [1] 53 0
Prevention
Comparator / control treatment
Usual ward care
Control group
Active

Outcomes
Primary outcome [1] 164 0
New onset of delirium in hospital.
Timepoint [1] 164 0
assessed every 48 hours during weekdays
Secondary outcome [1] 359 0
Functional status
Timepoint [1] 359 0
assessed every 48 hours during weekdays
Secondary outcome [2] 360 0
Discharge destination
Timepoint [2] 360 0
At hospital discharge
Secondary outcome [3] 361 0
Length of stay
Timepoint [3] 361 0
At hospital discharge

Eligibility
Key inclusion criteria
Hospital inpatient under a medical bed card in the trial area.
Minimum age
65 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe dysphasia, death expected within 24 hours, infectious isolation, documented contraindication to mobilisation, admission to the stroke or critical care unit, planned admission of less than 48 hours, major psychiatric diagnosis, admission for known delirium, admission from another hospital, previous inclusion in the study.

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)
sealed envelopes opened by person unaware of patient details
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each person is randomised to treatment group separately from a store of sealed envelopes (15 control, 15 intervention) which are replenished after each person is randomised. That is, the selection of treatment group occurs in much the same way as if a coin was tossed. There is no blocking or stratification.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Control is usual hospital care
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/05/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 178 0
Government body
Name [1] 178 0
Northern Health
Country [1] 178 0
Australia
Funding source category [2] 179 0
Government body
Name [2] 179 0
NHMRC
Country [2] 179 0
Australia
Funding source category [3] 180 0
Charities/Societies/Foundations
Name [3] 180 0
HCF Health and Medical Research Foundation
Country [3] 180 0
Australia
Primary sponsor type
Hospital
Name
Northern Clinical Research Centre
Address
185 Cooper St Epping VIC 3076
Country
Australia
Secondary sponsor category [1] 134 0
None
Name [1] 134 0
Not applicable
Address [1] 134 0
Country [1] 134 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 946 0
The Northern Hospital
Ethics committee address [1] 946 0
Ethics committee country [1] 946 0
Australia
Date submitted for ethics approval [1] 946 0
Approval date [1] 946 0
Ethics approval number [1] 946 0

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

Contacts
Principal investigator
Name 35935 0
Address 35935 0
Country 35935 0
Phone 35935 0
Fax 35935 0
Email 35935 0
Contact person for public queries
Name 9242 0
Kim Jeffs
Address 9242 0
Northern Clinical Research Centre
The Northern Hospital
185 Cooper St
Epping VIC 3076
Country 9242 0
Australia
Phone 9242 0
+61 3 84058804
Fax 9242 0
Email 9242 0
kim.jeffs@nh.org.au
Contact person for scientific queries
Name 170 0
Kim Jeffs
Address 170 0
Northern Clinical Research Centre
The Northern Hospital
185 Cooper St
Epping VIC 3076
Country 170 0
Australia
Phone 170 0
+61 3 84058804
Fax 170 0
+61 3 84058683
Email 170 0
kim.jeffs@nh.org.au

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.