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Trial registered on ANZCTR
Registration number
ACTRN12624000232538
Ethics application status
Approved
Date submitted
5/02/2024
Date registered
8/03/2024
Date last updated
10/05/2024
Date data sharing statement initially provided
8/03/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Feasibility and acceptability of a multicomponent lifestyle intervention program on changes in functional ability, cognition and quality of life in community dwelling older adults at risk of functional decline: A Pilot Study
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Scientific title
Is it feasible to carry out an outpatient multicomponent lifestyle intervention program to improve functional ability, maintain cognition and improve quality of life in community dwelling adults 65 years and over at risk of functional decline?
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Secondary ID [1]
311422
0
Nil known
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Universal Trial Number (UTN)
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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:
Ageing related functional decline
332709
0
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Ageing related cognitive decline
332939
0
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Condition category
Condition code
Neurological
329420
329420
0
0
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Dementias
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Neurological
329422
329422
0
0
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Alzheimer's disease
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Neurological
329423
329423
0
0
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Neurodegenerative diseases
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Public Health
329424
329424
0
0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The 12-week intervention program will be carried out once a week following a comprehensive geriatric assessment in a small group of 6-8 participants using the existing outpatient service facilities and staffing at an outpatient rehabilitation facility. 3x45-minute components will be included in each week's program. It will start with 45-minute individualised exercises consisting aerobic exercise (e.g. cycling, brisk walking), strength exercise (e.g. weights, squats) and balance exercises (Figure 8 walking, tandem stance/walking) in a circus style supervised by physiotherapists, followed by 45-minute computer-based cognitive training using a well-established program - BrainHQ (https://www.brainhq.com). The cognitive training session will be facilitated by occupational therapist(s) and laptops and iPads will be provided from the rehab facility or the participants may bring their own devices if they would prefer. A variety of cognitive domains will be trained which include attention (e.g. tracing objects), processing speed (e.g. spot the differences), memory (e.g. remembering spoken information, visual memory), problem solving (e.g. processing changing rules) and visuospatial/orientation (e.g. image rotation, sensing directions), with facilitated discussions on generalisation of the skills to everyday activities. The third 45-minute component of the program will consist of a series of topics including nutrition and diet education and tailored advice delivered by a dietitian, education on maintaining brain health and functional abilities delivered by an occupational therapist, education on promoting social interaction, stress management and mindfulness practice delivered by a social worker, and yoga delivered by a qualified yoga teacher.
As the age of the participants ranges from 65 to above 80 years, they may have multiple comorbidities (e.g. osteoarthritis, chronic pain, cardiopulmonary conditions, etc.) and their physical abilities and restrictions of physical activities may vary significantly, a tailored exercise program will be established for each participant based on their baseline assessment by a physiotherapist. This individualised program will be performed during the weekly exercise sessions and will be printed out in a user-friendly format and included in the purpose-designed Home Program Journal.
All participants will be required to continue practising all components of the program at home 3 times a week (at least a total of 2.25 hours of exercises and 2.25 hours of cognitive training, and at least 5 minutes each day on mindfulness practice). They are required to record activities performed on a purpose-designed Home Program Journal, which will be reviewed by relevant staff and feedback will be provided during the period of the program. Attendance will be checked each week of the program with a maximum of 3 non-attendance.
A follow-up phone call (or in-person follow-up, depending on participants’ preferences) at 3 months post program completion will be conducted to evaluate the sustainability of lifestyle changes (e.g. increased physical and cognitive activities, continuing healthy eating and mindfulness practice, etc.) as a result of the lasting impact of the intervention program.
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Intervention code [1]
327862
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Lifestyle
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Intervention code [2]
327863
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Prevention
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Intervention code [3]
327864
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Behaviour
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
337236
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Primary outcome is the feasibility of the Healthy Mind, Healthy Body Program.
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Assessment method [1]
337236
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A purpose-designed questionnaire will be used to obtain feedback on the program from the participants. A 5-point Likert scale and open-ended questions will be used to document the participants’ perception of the program design such as included components, duration and group size; the length and number of the assessments conducted; the duration, frequency, intensity, challenge of the sessions; and the requirement of performing and recording the home program.
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Timepoint [1]
337236
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At the end of intervention (week 12).
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Primary outcome [2]
337237
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Primary outcome is the acceptability of the Healthy Mind, Healthy Body Program.
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Assessment method [2]
337237
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A semi-structured focus group discussion with the 6-8 participants will be conducted at the conclusion of each of the 12-week intervention program (multiple groups will be conducted for the research project). The discussion will be conducted by the Principal Investigator Dr Weihong Zhang and will seek feedback from the participants on the experience and perceptions of the program content, design and delivery, barriers and facilitators of participation, and suggestions for program improvement.
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Timepoint [2]
337237
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At the end of intervention (week 12).
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Secondary outcome [1]
431157
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Physical ability
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Assessment method [1]
431157
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Berg Balance Test
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Timepoint [1]
431157
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At baseline (week 0) and end of intervention (week 12).
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Secondary outcome [2]
431158
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Physical ability
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Assessment method [2]
431158
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6-Minute Walk Test
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Timepoint [2]
431158
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At baseline (week 0) and end of intervention (week 12).
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Secondary outcome [3]
431159
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Physical ability
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Assessment method [3]
431159
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Sit-to-stand test
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Timepoint [3]
431159
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At baseline (week 0) and end of intervention (week 12).
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Secondary outcome [4]
431160
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Physical ability
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Assessment method [4]
431160
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Timed up & go test
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Timepoint [4]
431160
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At baseline (week 0) and end of intervention (week 12).
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Secondary outcome [5]
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Physical ability
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Assessment method [5]
431161
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Grip strength assessed with the use of a dynamometer
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Timepoint [5]
431161
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At baseline (week 0) and end of intervention (week 12).
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Secondary outcome [6]
431162
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Cognitive ability
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Assessment method [6]
431162
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Trial Making Test A & B
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Timepoint [6]
431162
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At baseline (week 0) and end of intervention (week 12).
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Secondary outcome [7]
431163
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Cognitive ability
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Assessment method [7]
431163
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Letter Digit Substitution Test
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Timepoint [7]
431163
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At baseline (week 0) and end of intervention (week 12).
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Secondary outcome [8]
431164
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Cognitive ability
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Assessment method [8]
431164
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Hopkins Verbal Learning Test - Revised
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Timepoint [8]
431164
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At baseline (week 0) and end of intervention (week 12).
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Secondary outcome [9]
431165
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Cognitive ability
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Assessment method [9]
431165
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Digit Span Test
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Timepoint [9]
431165
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At baseline (week 0) and end of intervention (week 12).
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Secondary outcome [10]
431166
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Mental status
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Assessment method [10]
431166
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Geriatric Depression Scale - short version
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Timepoint [10]
431166
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At baseline (week 0) and end of intervention (week 12).
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Secondary outcome [11]
431167
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Frailty status
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Assessment method [11]
431167
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Edmonton Frail Scale
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Timepoint [11]
431167
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At baseline (week 0) and end of intervention (week 12).
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Secondary outcome [12]
431168
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Quality of life status
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Assessment method [12]
431168
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36-Item Short Form Survey (SF-36)
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Timepoint [12]
431168
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At baseline (week 0) and end of intervention (week 12).
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Secondary outcome [13]
431169
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Nutritional and overall health risks
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Assessment method [13]
431169
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Body Mass Index (BMI) (height determined by stadiometer and weight determined using a chair scale)
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Timepoint [13]
431169
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At baseline (week 0) and end of intervention (week 12).
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Secondary outcome [14]
431170
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Nutritional and overall health risks
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Assessment method [14]
431170
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Waist circumference assessed with the use of a non-elastic tape measure
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Timepoint [14]
431170
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At baseline (week 0) and end of intervention (week 12).
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Secondary outcome [15]
431171
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Awareness of cardiovascular disease risk
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Assessment method [15]
431171
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ABCD Risk Questionnaire
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Timepoint [15]
431171
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At baseline (week 0) and end of intervention (week 12).
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Secondary outcome [16]
431172
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Level of functional activities
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Assessment method [16]
431172
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A purpose-designed Activity Level Checklist
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Timepoint [16]
431172
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At baseline (week 0) and end of intervention (week 12).
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Secondary outcome [17]
432081
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Nutritional and overall health risks
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Assessment method [17]
432081
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Hip circumference with the use of a non-elastic tape measure
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Timepoint [17]
432081
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At baseline (week 0) and end of intervention (week 12)
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Eligibility
Key inclusion criteria
• Community dwelling adults aged greater than or equal to 65 years
• Able to mobilise independently
• Able to exercise without rest for 15 minutes
• Able to perform instrumental activities of daily living tasks
• Commit to participate in the program once a week for 3 hours for 12 weeks at the allocated time
• Commit to perform home programs 2-3 times a week, a total of 1-2 hours each time
• Cognitive screening: Montreal Cognitive Assessment (MoCA) >= 24/30
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Minimum age
65
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?
Yes
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Key exclusion criteria
• Has been diagnosed with dementia
• Unstable medical conditions:
o unstable angina
o severe heart/lung disease that limits exercising
o severe postural hypotension
o anxiety or depression that may impact on participating activities
o severe pain
• Neurological Disease
o Parkinson’s disease
o Normal Pressure Hydrocephalus
o Traumatic Brain Injury
o Huntington’s disease
o Multiple Sclerosis
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The SPSS statistical software package will be used to analyse the data. Statistical analyses will provide descriptive data about the participants who participate in this study (gender, age, cognitive screening scores, and so forth). Ageing related outcomes will be assessed among participants using the validated tools – Berg Balance Test (BBT), 6-minute walk test (6MWT), sit-to-stand (STS), timed up & go (TUG), and grip strength; Trial Making Test A&B, Letter Digit Substitution Test (LDST), Hopkins Verbal Leaning Test – Revised (HVLT-R), Digit Span Test; Edmonton Frail Scale; Geriatric Depression Scale (GDS) short version; 36-Item Short Form Survey (SF-36) and ABCD Risk Questionnaire at baseline (week 0) and end of intervention (week 12). The results will be reported as the mean±SD. This will inform a further larger study which will be randomised with adequate power to investigate change.
Qualitative data will be analysed based on the purpose-designed questionnaire and focus group discussions. Reflexive thematic analysis will be undertaken to analyse the responses and perceptions from the participants.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
28/08/2024
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Actual
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Date of last participant enrolment
Anticipated
28/08/2024
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Actual
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Date of last data collection
Anticipated
2/09/2026
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Actual
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Sample size
Target
30
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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]
26103
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Wolper Jewish Hospital - Woollahra
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Recruitment postcode(s) [1]
41959
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2025 - Woollahra
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Funding & Sponsors
Funding source category [1]
315692
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Hospital
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Name [1]
315692
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Wolper Jewish Hospital
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Address [1]
315692
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Country [1]
315692
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Australia
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Primary sponsor type
University
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Name
The University of Sydney
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Address
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Country
Australia
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Secondary sponsor category [1]
317794
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None
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Name [1]
317794
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Address [1]
317794
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Country [1]
317794
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314562
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The University of Sydney Human Research Ethics Committee
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Ethics committee address [1]
314562
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https://www.sydney.edu.au/research/research-integrity-and-ethics.html
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Ethics committee country [1]
314562
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Australia
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Date submitted for ethics approval [1]
314562
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22/01/2024
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Approval date [1]
314562
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14/03/2024
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Ethics approval number [1]
314562
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2024/107
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Summary
Brief summary
This research project aims to investigate the feasibility and acceptability of a multicomponent lifestyle intervention program in community dwelling adults aged 65 and over who are at risk of functional decline. It will also explore the potential effectiveness of the program on ageing related functions. The project aims to recruit 30 participants. The 12-week multicomponent intervention is an established outpatient program at a rehabilitation facility. The program includes individualised physical exercises, facilitated cognitive training and a collection of other lifestyle components including nutritional intervention, mindfulness practice, social interaction, yoga, and healthy ageing strategy education. A comprehensive geriatric assessment is also part of the program. A purpose-designed questionnaire and a semi-structured focus group discussion will be completed at the end of intervention to evaluate the feasibility and acceptability of the program. Assessments on ageing-related outcome measures will be completed at baseline and end-of-intervention.
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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
132022
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Dr Weihong Zhang
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Address
132022
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Sydney School of Health Sciences, Faculty of Medicine & Health, The University of Sydney. Level 7, Susan Wakil Health Building (D18), Western Ave, Camperdown NSW 2006
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Country
132022
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Australia
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Phone
132022
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+61 2 93519438
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Fax
132022
0
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Email
132022
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[email protected]
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Contact person for public queries
Name
132023
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Weihong Zhang
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Address
132023
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Sydney School of Health Sciences, Faculty of Medicine & Health, The University of Sydney. Level 7, Susan Wakil Health Building (D18), Western Ave, Camperdown NSW 2006
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Country
132023
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Australia
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Phone
132023
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+61 2 93519438
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Fax
132023
0
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Email
132023
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[email protected]
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Contact person for scientific queries
Name
132024
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Weihong Zhang
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Address
132024
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Sydney School of Health Sciences, Faculty of Medicine & Health, The University of Sydney. Level 7, Susan Wakil Health Building (D18), Western Ave, Camperdown NSW 2006
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Country
132024
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Australia
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Phone
132024
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+61 2 93519438
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Fax
132024
0
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Email
132024
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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