Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000437864
Ethics application status
Approved
Date submitted
5/03/2021
Date registered
16/04/2021
Date last updated
16/04/2021
Date data sharing statement initially provided
16/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Does perception of walking abilities relate to executive function and falls in older adults undergoing rehabilitation?
Scientific title
Does perception of walking abilities relate to executive function and falls in older adults undergoing rehabilitation?
Secondary ID [1] 302664 0
Nil
Universal Trial Number (UTN)
U1111-1260-5649
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 319576 0
Falling 319577 0
Fracture 319578 0
Condition category
Condition code
Musculoskeletal 317519 317519 0 0
Osteoporosis
Physical Medicine / Rehabilitation 317520 317520 0 0
Physiotherapy
Neurological 319190 319190 0 0
Dementias

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The relationship between executive function and perception of walking abilities will be assessed in patient's aged 60 years or over undergoing in-patient rehabilitation. The relationship between these measures and falls or hospital re-admission will be assessed after 12 months.
Executive function will be assessed by the Trail making test (conducted at baseline and after 12 months) and perception of walking abilities will be determined by the relationship between the physical timed up and go and imagined timed up and go (conducted at baseline and after 12 months).
Intervention code [1] 319907 0
Diagnosis / Prognosis
Intervention code [2] 319908 0
Early Detection / Screening
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326744 0
Imagined timed-up and go - this assesses motor planning and higher level gait disorders
Timepoint [1] 326744 0
Baseline and at 12 month post-discharge
Primary outcome [2] 326745 0
Trail making test A & B - used to assess executive function
Timepoint [2] 326745 0
Baseline and at 12 month post-discharge
Secondary outcome [1] 392544 0
Activities-specific balance confidence scale 6
Timepoint [1] 392544 0
Baseline and at 12 month post-discharge
Secondary outcome [2] 392545 0
Grip strength - assessed with a grip strength dynamometer
Timepoint [2] 392545 0
Baseline and at 12 month post-discharge
Secondary outcome [3] 392554 0
Cognition assessed via the Rowland Universal Dementia Assessment Scale (RUDAS)
Timepoint [3] 392554 0
Baseline and at 12 month post-discharge

Eligibility
Key inclusion criteria
In-patients of Brighton health campus aged at least 60 years; able to get out of an armchair independently; able to walk at least 10 metres independently (with the use of a walking aid if required).
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Uncontrolled cardiovascular disease, recent stroke, unable to get out of an armchair independently or unable to walk at least 10 metres independently (with the use of a walking aid if required).

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
All statistical analyses will be performed using IBM SPSS (Version 22). Statistical significance is set at p < 0.05. Normality of distribution of the test measures will be confirmed using the Shapiro-Wilk test. Outcome measures will be presented as mean (standard deviation).
Pearson correlation coefficients will be used to identify relationship between TUG delta and executive function (Trail making test). A multiple linear regression model will be used to determine the independent association of TUG delta and executive function on falls over a 12-month period. Independent variables of TUG physical, cognition, grip strength and relevant demographics will be stepwise entered into the model if they increase the probability of F by at least 0.05

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/04/2021
Actual
Date of last participant enrolment
Anticipated
29/07/2022
Actual
Date of last data collection
Anticipated
28/07/2023
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 18864 0
Brighton Health Campus - Brighton
Recruitment postcode(s) [1] 33370 0
4017 - Brighton

Funding & Sponsors
Funding source category [1] 307104 0
Hospital
Name [1] 307104 0
Brighton Health Campus
Country [1] 307104 0
Australia
Primary sponsor type
Hospital
Name
Brighton Health Campus
Address
449 Hornibrook Hwy, Brighton QLD 4017
Country
Australia
Secondary sponsor category [1] 307673 0
None
Name [1] 307673 0
Address [1] 307673 0
Country [1] 307673 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307218 0
Royal Brisbane & Women’s Hospital Human Research Ethics Committee
Ethics committee address [1] 307218 0
Ethics committee country [1] 307218 0
Australia
Date submitted for ethics approval [1] 307218 0
31/08/2020
Approval date [1] 307218 0
12/10/2020
Ethics approval number [1] 307218 0
HREC/2020/QRBW/66035

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

Contacts
Principal investigator
Name 106446 0
Dr Vaughan Nicholson
Address 106446 0
Australian Catholic University, 1100 Nudgee Road Banyo QLD 4014
Country 106446 0
Australia
Phone 106446 0
+61 7 36237687
Fax 106446 0
Email 106446 0
[email protected]
Contact person for public queries
Name 106447 0
Vaughan Nicholson
Address 106447 0
Australian Catholic University, 1100 Nudgee Road Banyo QLD 4014
Country 106447 0
Australia
Phone 106447 0
+61 7 36237687
Fax 106447 0
Email 106447 0
[email protected]
Contact person for scientific queries
Name 106448 0
Vaughan Nicholson
Address 106448 0
Australian Catholic University, 1100 Nudgee Road Banyo QLD 4014
Country 106448 0
Australia
Phone 106448 0
+61 7 36237687
Fax 106448 0
Email 106448 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only (after de-identification)
When will data be available (start and end dates)?
Immediately following publication, and ending 5 years following main results publication
Available to whom?
Researchers who provide a methodologically sound proposal
Available for what types of analyses?
any purpose, such as for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


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.