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Trial registered on ANZCTR


Registration number
ACTRN12615000568516
Ethics application status
Approved
Date submitted
5/05/2015
Date registered
2/06/2015
Date last updated
24/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Combatting Frailty in Older Men with multifaceted individually tailored intervention including exercise, diet and behavior.
Scientific title
A single blind randomised trial on combatting frailty in older men through a multifaceted individually tailored interventions including exercise, dietary supplementation, and behavioural activation.
Secondary ID [1] 286641 0
Nil Known
Universal Trial Number (UTN)
U1111-1169-5746
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical medicine/Rehabilitation 295122 0
Diet and nutrition 295123 0
Mental Health 295124 0
Condition category
Condition code
Physical Medicine / Rehabilitation 295228 295228 0 0
Physiotherapy
Diet and Nutrition 295366 295366 0 0
Other diet and nutrition disorders
Mental Health 295367 295367 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention period is now only six months not 3 years.
Intervention code [1] 291783 0
Early detection / Screening
Intervention code [2] 291910 0
Lifestyle
Intervention code [3] 291911 0
Behaviour
Comparator / control treatment
No treatment.
Control group
Active

Outcomes
Primary outcome [1] 294981 0
The composite primary outcome analysis will be based on intention to treat, comparing the survival in the intervention group to the survivial in the control group using cox proportional hazards regression adjusted for age and level of frailty at baseline. Mortality will be determined through two sources- direct contact with next of kin of men unable to be contacted and through mortality register linked data. Residential care admission will be ascertained through next of kin and hospital records as required.
Timepoint [1] 294981 0
End of six months
Secondary outcome [1] 314503 0
Frailty status as measured by FRAIL scale score.

Timepoint [1] 314503 0
Baseline and six months
Secondary outcome [2] 314646 0
Health service usage as assessed by HIMS questionnaire responses and linked data, ( including emergency admissions HACC and ACAP data)
Timepoint [2] 314646 0
Baseline and six months
Secondary outcome [3] 314647 0
Disability as measured by activities of daily living (ADL's).
Timepoint [3] 314647 0
Baseline and six months
Secondary outcome [4] 314648 0
Physical performance as assessed by
Timed up and Go (TUG),
Step Test: a dynamic test of single leg stance balance(Hill et al, 1996),
Functional Reach test: a dynamic bilateral stance tests of standing balance (Duncan et al,1990),
Timed sit to stand (five times, Tinetti et al, 1995) and
Knee Extension (quadriceps) strength (Lord et al, 2003).
Timepoint [4] 314648 0
Baseline and six months
Secondary outcome [5] 314649 0
Changes in cognition as assessed using cognition (MMSE) test.
Timepoint [5] 314649 0
Baseline and six months
Secondary outcome [6] 314650 0
Composite outcome of total number of medications and inapporpriate medications, assessed by validating medications and/or prescriptions.
Timepoint [6] 314650 0
Baseline and six months
Secondary outcome [7] 314651 0
Falls as self reported in HIMS questionnaire and specifically designed exercise program journal plus linked data.
Timepoint [7] 314651 0
Baseline and six months
Secondary outcome [8] 314787 0
Changes in depression as assessed by PHQ9 score.
Timepoint [8] 314787 0
Baseline and six months
Secondary outcome [9] 314788 0
Quality of life as assessed by HIMS questionnaire.
Timepoint [9] 314788 0
Baseline and six months

Eligibility
Key inclusion criteria
Men who were previously part of the HIMS cohort study
(Norman et al 2009) who are currently all over the age of 83 years who are frail or prefrail on the FRAIL scale.(McCaul et al, 2015)
Minimum age
83 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: men with moderate cognitive impairment (MMSE) (Folstein et al, 1975), or who have evidence of major illness likely to cause death within six months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random generation order using a randomisation table created by computer sequenced generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
In both the primary and secondary analyses, we expect that the intervention effect will differ in the men who were pre-frail and the men who were frail at baseline and we will formally test this by fitting an interaction between the intervention variable and baseline frailty. Sample size calculation - we conservatively expect to recruit and randomise 200 men in each arm of the trial. We obtained ABS life tables that estimated the annual age-specific mortality risk by individual age. From AIHW we obtained the number of incident admissions to residential aged care facilites(RACF) by individual age in 2014 and together with ABS estimated resident population counts by individual age, we estimated the age specific risk of RACF admission. From these, we estimated that 55% of participants would be event free (alive and not in RACF) after three years of follow up. Given this, we expect the event risk in Contol arm to be 45% with our expected sample size (200 in each arm) we used Freemans' sample size calculation (Freedman, 1982) for the logrank test to estimate we would have 80% power to detect and event risk of 31% ( i.e. a 30% relative reduction) in the Intervention Arm at the 5% levle of significance.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 291216 0
Government body
Name [1] 291216 0
NHMRC
Address [1] 291216 0
National Health and Medical Research Council
GPO Box 1421
CANBERRA ACT 2601
Country [1] 291216 0
Australia
Primary sponsor type
Individual
Name
Professor Leon Flicker
Address
Western Australian Centre for Health and Ageing (WACHA)
M577 University of Western Australia
35 Stirling H'way
CRAWLEY WA 6009
Country
Australia
Secondary sponsor category [1] 289895 0
Individual
Name [1] 289895 0
Professor Osvaldo Almeida


Address [1] 289895 0
c/- WACHA M577
University of Western Australia
35 Stirling H'way
CRAWLEY WA 6009
Country [1] 289895 0
Australia
Secondary sponsor category [2] 289978 0
Individual
Name [2] 289978 0
Professor Keith Hill
Address [2] 289978 0
Curtin University Faculty of Health Science
School of Physiotherapy & Exercise Science,
408 Level 3
Kent St
BENTLEY WA 6845
Country [2] 289978 0
Australia
Secondary sponsor category [3] 289979 0
Individual
Name [3] 289979 0
Prof Caryl Nowson
Address [3] 289979 0
Deakin University
Faculty of Health
Geelong Waurn Ponds Campus
75 Pigdons Road
Waurn Ponds
GEELONG VIC 3220
Country [3] 289979 0
Australia
Secondary sponsor category [4] 289980 0
Individual
Name [4] 289980 0
Assoc Prof Christopher Etherton-Beer
Address [4] 289980 0
C/- WACHA
University of Western Australia
M577, 35 Stirling H'way
CRAWLEY WA 6009
Country [4] 289980 0
Australia
Secondary sponsor category [5] 289981 0
Individual
Name [5] 289981 0
Assoc Prof Bu Yeap
Address [5] 289981 0
c/- WACHA M577
University of Western Australia
35 Stirling H'way
CRAWLEY WA 6009
Country [5] 289981 0
Australia
Secondary sponsor category [6] 289982 0
Individual
Name [6] 289982 0
Assoc Prof Kieran McCaul
Address [6] 289982 0
c/- WACHA M577
University of Western Australia
35 Stirling H'way
CRAWLEY WA 6009
Country [6] 289982 0
Australia
Other collaborator category [1] 278470 0
Individual
Name [1] 278470 0
Professor Graeme Hankey
Address [1] 278470 0
c/- WACHA M577
University of Western Australia
35 Stirling H'way
CRAWLEY WA 6009
Country [1] 278470 0
Australia
Other collaborator category [2] 278471 0
Individual
Name [2] 278471 0
Professor Paul Norman
Address [2] 278471 0
c/- WACHA M577
University of Western Australia
35 Stirling H'way
CRAWLEY WA 6009
Country [2] 278471 0
Australia
Other collaborator category [3] 278472 0
Individual
Name [3] 278472 0
Professor Jonathon Golledge
Address [3] 278472 0
School of Medicine and Dentistry
Vascular Biology Unit
Douglas Campus
James Cook University
1 James Cook Drive
TOWNSVILLE QLD 4811
Country [3] 278472 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292779 0
University of Western Australia Human Research Ethics Office
Ethics committee address [1] 292779 0
M459
35 Stirling Highway
CRAWLEY WA 6009
Ethics committee country [1] 292779 0
Australia
Date submitted for ethics approval [1] 292779 0
Approval date [1] 292779 0
27/02/2015
Ethics approval number [1] 292779 0
RA/4/1/ 576

Summary
Brief summary
Frailty is a common syndrome in older adults caused by a decline in reserve capacity of the body's systems used to maintain health. We are interested as to whether interventions for frailty work BEFORE the involvement of clinical services. We propose to undertake a trial of community dwelling older men to determine whether a simple package of interventions can combat this syndrome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56986 0
Prof Leon Flicker
Address 56986 0
Director, Western Australian Centre for Health & Ageing (WACHA),
Centre for Medical Research
University of Western Australia
M577 35 Stirling H'way
CRAWLEY WA 6009
Country 56986 0
Australia
Phone 56986 0
618 92243992
Fax 56986 0
618 9224 8009
Email 56986 0
leon.flicker@uwa.edu.au
Contact person for public queries
Name 56987 0
Ms Jill George
Address 56987 0
HIMS Study Coordinator
University of Western Australia
M577 35 Stirling H'way
CRAWLEY WA 6009
Country 56987 0
Australia
Phone 56987 0
618 9224 1699
Fax 56987 0
Email 56987 0
jill.george@uwa.edu.au
Contact person for scientific queries
Name 56988 0
Prof Leon Flicker
Address 56988 0
Director, Western Australian Centre for Health & Ageing (WACHA),
Centre for Medical Research
University of Western Australia
M577 35 Stirling H'way
CRAWLEY WA 6009
Country 56988 0
Australia
Phone 56988 0
618 92243992
Fax 56988 0
Email 56988 0
leon.flicker@uwa.edu.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary