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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
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?
Secondary ID [1] 311422 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ageing related functional decline 332709 0
Ageing related cognitive decline 332939 0
Condition category
Condition code
Neurological 329420 329420 0 0
Dementias
Neurological 329422 329422 0 0
Alzheimer's disease
Neurological 329423 329423 0 0
Neurodegenerative diseases
Public Health 329424 329424 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 327862 0
Lifestyle
Intervention code [2] 327863 0
Prevention
Intervention code [3] 327864 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337236 0
Primary outcome is the feasibility of the Healthy Mind, Healthy Body Program.
Timepoint [1] 337236 0
At the end of intervention (week 12).
Primary outcome [2] 337237 0
Primary outcome is the acceptability of the Healthy Mind, Healthy Body Program.
Timepoint [2] 337237 0
At the end of intervention (week 12).
Secondary outcome [1] 431157 0
Physical ability
Timepoint [1] 431157 0
At baseline (week 0) and end of intervention (week 12).
Secondary outcome [2] 431158 0
Physical ability
Timepoint [2] 431158 0
At baseline (week 0) and end of intervention (week 12).
Secondary outcome [3] 431159 0
Physical ability
Timepoint [3] 431159 0
At baseline (week 0) and end of intervention (week 12).
Secondary outcome [4] 431160 0
Physical ability
Timepoint [4] 431160 0
At baseline (week 0) and end of intervention (week 12).
Secondary outcome [5] 431161 0
Physical ability
Timepoint [5] 431161 0
At baseline (week 0) and end of intervention (week 12).
Secondary outcome [6] 431162 0
Cognitive ability
Timepoint [6] 431162 0
At baseline (week 0) and end of intervention (week 12).
Secondary outcome [7] 431163 0
Cognitive ability
Timepoint [7] 431163 0
At baseline (week 0) and end of intervention (week 12).
Secondary outcome [8] 431164 0
Cognitive ability
Timepoint [8] 431164 0
At baseline (week 0) and end of intervention (week 12).
Secondary outcome [9] 431165 0
Cognitive ability
Timepoint [9] 431165 0
At baseline (week 0) and end of intervention (week 12).
Secondary outcome [10] 431166 0
Mental status
Timepoint [10] 431166 0
At baseline (week 0) and end of intervention (week 12).
Secondary outcome [11] 431167 0
Frailty status
Timepoint [11] 431167 0
At baseline (week 0) and end of intervention (week 12).
Secondary outcome [12] 431168 0
Quality of life status
Timepoint [12] 431168 0
At baseline (week 0) and end of intervention (week 12).
Secondary outcome [13] 431169 0
Nutritional and overall health risks
Timepoint [13] 431169 0
At baseline (week 0) and end of intervention (week 12).
Secondary outcome [14] 431170 0
Nutritional and overall health risks
Timepoint [14] 431170 0
At baseline (week 0) and end of intervention (week 12).
Secondary outcome [15] 431171 0
Awareness of cardiovascular disease risk
Timepoint [15] 431171 0
At baseline (week 0) and end of intervention (week 12).
Secondary outcome [16] 431172 0
Level of functional activities
Timepoint [16] 431172 0
At baseline (week 0) and end of intervention (week 12).
Secondary outcome [17] 432081 0
Nutritional and overall health risks
Timepoint [17] 432081 0
At baseline (week 0) and end of intervention (week 12)

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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/08/2024
Actual
Date of last participant enrolment
Anticipated
28/08/2024
Actual
Date of last data collection
Anticipated
2/09/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26103 0
Wolper Jewish Hospital - Woollahra
Recruitment postcode(s) [1] 41959 0
2025 - Woollahra

Funding & Sponsors
Funding source category [1] 315692 0
Hospital
Name [1] 315692 0
Wolper Jewish Hospital
Country [1] 315692 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 317794 0
None
Name [1] 317794 0
Address [1] 317794 0
Country [1] 317794 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314562 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 314562 0
Ethics committee country [1] 314562 0
Australia
Date submitted for ethics approval [1] 314562 0
22/01/2024
Approval date [1] 314562 0
14/03/2024
Ethics approval number [1] 314562 0
2024/107

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

Contacts
Principal investigator
Name 132022 0
Dr Weihong Zhang
Address 132022 0
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
Country 132022 0
Australia
Phone 132022 0
+61 2 93519438
Fax 132022 0
Email 132022 0
weihong.zhang@sydney.edu.au
Contact person for public queries
Name 132023 0
Weihong Zhang
Address 132023 0
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
Country 132023 0
Australia
Phone 132023 0
+61 2 93519438
Fax 132023 0
Email 132023 0
weihong.zhang@sydney.edu.au
Contact person for scientific queries
Name 132024 0
Weihong Zhang
Address 132024 0
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
Country 132024 0
Australia
Phone 132024 0
+61 2 93519438
Fax 132024 0
Email 132024 0
weihong.zhang@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.