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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12621000058875
Ethics application status
Approved
Date submitted
22/08/2020
Date registered
25/01/2021
Date last updated
25/01/2021
Date data sharing statement initially provided
25/01/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
The D-Frail Study 1: Association between vascular endothelial dysfunction and physical frail in patients with cardiovascular comorbidities: A prospective crossectional cohort study
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Scientific title
The D-Frail Study 1: Association between vascular endothelial dysfunction and physical frail in patients with cardiovascular comorbidities: A prospective crossectional cohort study – Interplay between vitamin D deficiency, chronic inflammation and sarcopenia
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Secondary ID [1]
301646
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Nil Known
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Universal Trial Number (UTN)
U1111-1254-3879
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Physical frailty
318057
0
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Sarcopenia
318058
0
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Cognitive frailty
318059
0
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Vascular endothelial dysfunction
318060
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Condition category
Condition code
Cardiovascular
316090
316090
0
0
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Other cardiovascular diseases
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Musculoskeletal
316091
316091
0
0
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Other muscular and skeletal disorders
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Mental Health
316092
316092
0
0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
A single-centred, prospective cross-sectional analytical study will be carried out. Patients with diagnosed Cardiovascular disease conditions will be recruited from outpatient clinics of acute care hospital. Written informed consent will be taken from all patients who are willing to participate the study at screening stage. At the time of enrolment to the study, the participants will be given a unique study identification number, which will be used to identify the participants throughout the study, until study completion. No identifiable information will be used in the records. Study master list with identifiers will be securely kept separately from the list of unique IDs given to the participants and study data records. The participants will be screened for their frailty states (30 min clinical assessment involving muscle strength assessment by hand grip strength measurement, physical and cognitive function assessments, dietary intake of vitamin D and sun exposure levels assessments by questionnaires) and blood tests to assess vascular function and inflammatory markers and plasma vitamin D levels.
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Intervention code [1]
319075
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Not applicable
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Comparator / control treatment
Singled armed
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
324873
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Sarcopenia assessed by hand grip strength measured by hand-held Dynamometer
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Assessment method [1]
324873
0
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Timepoint [1]
324873
0
At single assessment point
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Primary outcome [2]
324874
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Vascular endothelial dysfunction measured by blood plasma markers (Asymmetric dimethylarginine [ADMA] and Thrombospondin 1 [TSP 1]) level measured by Enzyme linked immunosorbent assay (ELISA)
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Assessment method [2]
324874
0
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Timepoint [2]
324874
0
At single assessment point
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Primary outcome [3]
326078
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Inflammation assessed by plasma inflammatory markers (IL-6, hs-CRP) measured by ELISA
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Assessment method [3]
326078
0
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Timepoint [3]
326078
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At single assessment point
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Secondary outcome [1]
386054
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Cognitive frailty assessed by MiniCog assessment method at single assessment point
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Assessment method [1]
386054
0
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Timepoint [1]
386054
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At single assessment point
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Secondary outcome [2]
386055
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Plasma vitamin D level measured by ELISA
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Assessment method [2]
386055
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Timepoint [2]
386055
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At single assessment point
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Eligibility
Key inclusion criteria
Age greater than or equal to 45 years,
Diagnosed with cardiovascular condition
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Minimum age
45
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Diagnosed renal/liver diseases
Pregnant or breastfeeding
Severe cognitive impairment (i.e. dementia/alzheimer's disease)
Diagnosed musculoskeletal disorders
Unable to communicate without an interpreter
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Random sample
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Timing
Prospective
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Statistical methods / analysis
Descriptive analysis will be carried-out to assess the demographic and situational data.
Study participants will be stratified to sarcopenic and non-sarcopenic based on accepted cut-off points.
Data from sarcopenic and non-sarcopenic sub groups will be evaluated by t-tests (un-paired)/Mann–Whitney U test, linear regression analysis and multivariate logistic regression to evaluate the independent effects.
Study 1: Data will be stratified based on vitamin D status and frailty/sarcopenic status.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
28/01/2021
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Actual
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Date of last participant enrolment
Anticipated
1/05/2021
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Actual
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Date of last data collection
Anticipated
1/05/2021
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Actual
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Sample size
Target
183
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
17306
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Blacktown Hospital - Blacktown
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Recruitment postcode(s) [1]
31032
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2148 - Blacktown
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Funding & Sponsors
Funding source category [1]
306080
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Other Collaborative groups
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Name [1]
306080
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The Sydney Partnership for Health, Education, Research and Enterprise (SPHERE), Cardiac and Vascular Health Clinical Academic Group - Early/Mid research career Seed Grant fund (2019-2021)
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Address [1]
306080
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University of New South Wales (UNSW), L2, AGSM Building, Botany Street, Randwick NSW 2052
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Country [1]
306080
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Australia
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Funding source category [2]
306525
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Other
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Name [2]
306525
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Blackmores Institute
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Address [2]
306525
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20 Jubilee Avenue, Warriewood, NSW, 2102, Australia
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Country [2]
306525
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Australia
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Primary sponsor type
Government body
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Name
Western Sydney Local Health District
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Address
Blacktown Hospital, Western Sydney Local Health District,
Marcel Crescent, Blacktown, NSW, 2148, Australia
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Country
Australia
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Secondary sponsor category [1]
306542
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University
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Name [1]
306542
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Western Sydney University
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Address [1]
306542
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Western Sydney University, Research Services, Ground Floor, Building BA, Penrith Campus (Werrington South), Great Western Highway Werrington NSW
2747
NSW, Australia
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Country [1]
306542
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306301
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Western Sydney Local Health District HREC
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Ethics committee address [1]
306301
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WESTERN SYDNEY LOCAL HEALTH DISTRICT, Research Office, Level 2, REN Building Westmead Hospital, Hawkesbury & Darcy Roads, Westmead NSW 2145
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Ethics committee country [1]
306301
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Australia
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Date submitted for ethics approval [1]
306301
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14/05/2020
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Approval date [1]
306301
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18/08/2020
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Ethics approval number [1]
306301
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2020/ETH01551
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Summary
Brief summary
The WSLHD HREC has approved project, certifying that the study proposal meets the requirements of the National Statement. The ethical approval for this research project is granted to be conducted at Blacktown Mount Druitt Hospital.
The WSLHD HREC has been accredited by the NSW Department of Health as a lead HREC to provide the single ethical and scientific review of proposals to conduct research within the NSW public health system. This lead HREC is constituted and operates in accordance with the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research and the CPMP/ICH Note for Guidance on Good Clinical Practice.
The request to undertake the above protocol was reviewed by a subcommittee of members of the Scientific Advisory Committee (SAC) and the Human Research Ethics Committee (HREC) (Western Sydney Local Health District).
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
103422
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Dr Anjalee Amarasekera
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Address
103422
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Blacktown Clinical and Research School, Western Sydney University, Marcel Crescent, Blacktown Hospital, NSW, 2148, Australia
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Country
103422
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Australia
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Phone
103422
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+61 400225593
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Fax
103422
0
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Email
103422
0
[email protected]
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Contact person for public queries
Name
103423
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Dr Anjalee Amarasekera
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Address
103423
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Blacktown Clinical and Research School, Western Sydney University, Marcel Crescent, Blacktown Hospital, NSW, 2148, Australia
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Country
103423
0
Australia
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Phone
103423
0
+61 400225593
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Fax
103423
0
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Email
103423
0
[email protected]
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Contact person for scientific queries
Name
103424
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Dr Anjalee Amarasekera
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Address
103424
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Blacktown Clinical and Research School, Western Sydney University, Marcel Crescent, Blacktown Hospital, NSW, 2148, Australia
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Country
103424
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Australia
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Phone
103424
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+61 400225593
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Fax
103424
0
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Email
103424
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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