Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


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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
Trial registered on ANZCTR


Registration number
ACTRN12620001120965
Ethics application status
Approved
Date submitted
2/09/2020
Date registered
29/10/2020
Date last updated
29/10/2020
Date data sharing statement initially provided
29/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
How accurately do pre-admission surgical patients report the ability to climb a flight of stairs?
Scientific title
Climbing a flight of stairs: Pre-admission surgical patient self-report compared to objective measurements
Secondary ID [1] 302220 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fitness for surgery 318915 0
cardiorespiratory fitness 319247 0
Condition category
Condition code
Surgery 316895 316895 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Location: pre-admission clinic and hospital corridor
Procedure: NB: these procedures are part of the study, not a usual component of routine preadmission standard assessment. The study procedures will occur during the routine PAC visit, which may occur at any time between one month and one day prior to surgery. The study procedures will be completed at a single session, anticipated to take no more than 30 minutes to complete all components.
1) questionnaire - International Physical Activity Questionnaire, Duke Activity Status Index, self-rating of ease of stair climbing
2) self-rating of ability to climb a flight of stairs. This will be done using a simple Likert scale. As there is no previous research on this particular question, there is no established tool for this. The researcher will then take the patient to a flight of stairs in the hospital and time how long it takes to ascend.
3) A near-infra-red spectroscopy monitor will be placed on the calf prior to activity to measure muscle oxygen saturation
Timing: once
Researcher: university students
Intervention code [1] 318512 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324999 0
Association between self-rated ability to climb stairs and objective measurement of ability to climb stairs by calculation of work using mass moved x time taken x distance covered. Self-rated ability will use a 5 point Likert scale. Patient mass will be taken from the weight recorded as part of the routine PAC nursing assessment. Time will be measured with a stop watch. Distance: the height of the stairs and therefore the distance covered will be pre-measured.
Timepoint [1] 324999 0
At time of stair climb performance
Secondary outcome [1] 386512 0
Association between subjective measure (self-rated ability) of stair climb ability with physiological measurement of lower limb muscle oxygen saturation using near infra-red spectroscopy.
Timepoint [1] 386512 0
At the time of stair climb performance
Secondary outcome [2] 387393 0
Association between objective measure (power calculation) of stair climb ability with physiological measurement of lower limb muscle oxygen saturation using near infra-red spectroscopy. Objective calculation of power will be performed using the following equation: Power = mass x time x vertical distance
Timepoint [2] 387393 0
At time of stair climb

Eligibility
Key inclusion criteria

- All patients at preadmission clinic (PAC) as a convenience sample
- We will aim for a range of ages and weights and operation severity
- Patients who use a walking aid will be included if they are willing to perform as they usually would when asked to climb a FOS
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- age < 18yr,
- a measure of adiposity beyond which the NIRS is likely to be unreliable (currently thought to be a BMI > 60 kg/m2),
- if a patient answers “impossible” to ease of climbing a flight of stairs then the study will not continue

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
- Sample size – initial feasibility testing sample of 100 patients
- Will be numerical, ordinal, and nominal ranges for both the baseline data and for the objective data
- NIRS data will be interpreted from an excel spreadsheet, with averaging of saturation levels over the various periods

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/11/2020
Actual
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17422 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 31150 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 306642 0
Hospital
Name [1] 306642 0
The Wollongong Hospital
Country [1] 306642 0
Australia
Primary sponsor type
Government body
Name
Illawarra Shoalhaven Local Health District (ISLHD)
Address
Dept of Anaesthesia, Wollongong Hospital, Crown St, Wollongong, NSW, 2500
Country
Australia
Secondary sponsor category [1] 307192 0
None
Name [1] 307192 0
Nil
Address [1] 307192 0
Country [1] 307192 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306826 0
UOW and ISLHD Health and Medical Human Research Committee
Ethics committee address [1] 306826 0
Ethics committee country [1] 306826 0
Australia
Date submitted for ethics approval [1] 306826 0
Approval date [1] 306826 0
20/07/2020
Ethics approval number [1] 306826 0
2020/ETH00623

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

Contacts
Principal investigator
Name 105146 0
A/Prof Natalie Smith
Address 105146 0
Department of Anaesthesia Wollongong Hospital Wollongong, NSW, 2500
Country 105146 0
Australia
Phone 105146 0
+61 0439473790
Fax 105146 0
Email 105146 0
[email protected]
Contact person for public queries
Name 105147 0
Natalie Smith
Address 105147 0
Department of Anaesthesia Wollongong Hospital Wollongong, NSW, 2500
Country 105147 0
Australia
Phone 105147 0
+61 0439473790
Fax 105147 0
Email 105147 0
[email protected]
Contact person for scientific queries
Name 105148 0
Natalie Smith
Address 105148 0
Department of Anaesthesia Wollongong Hospital Wollongong, NSW, 2500
Country 105148 0
Australia
Phone 105148 0
+61 0439473790
Fax 105148 0
Email 105148 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers who provide a sound reason

Conditions for requesting access:
• -

What individual participant data might be shared?
• Individual participant data can be shared after de-identification

What types of analyses could be done with individual participant data?
• For any type of analysis

When can requests for individual participant data be made (start and end dates)?
From:
Start: immediately after publication
End: 2 years after the start date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Subject to approval of Principle Investigator via email address: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.