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Trial registered on ANZCTR


Registration number
ACTRN12618001069246
Ethics application status
Approved
Date submitted
12/06/2018
Date registered
27/06/2018
Date last updated
27/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot evaluation of the effect of an exercise intervention on quality of life for Australians living in residential aged care
Scientific title
Pilot evaluation of exercise intervention for Australians living in residential aged care
Secondary ID [1] 292566 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Older Adults Living in Long-Term Care Facilitities 304235 0
Falls 308502 0
Quality of Life 308503 0
Condition category
Condition code
Public Health 303585 303585 0 0
Health promotion/education
Physical Medicine / Rehabilitation 303586 303586 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: the exercise program designed to provide optimal stimulus to the cardiorespiratory and neuromuscular systems while maximising safety, compliance, and retention for older Australians living in residential aged care facilities (RACFs).

The exercise program adheres to the recommendations for physical activity for older adults living in RACF released by the International Association of Gerontology and Geriatrics Global Aging Research Network (De Souto Barreto et al 2016). The program involves twice weekly group exercise sessions of 35-45 min duration per session for 12 weeks. The exercise sessions will comprise a combination of aerobic/endurance (bouts of >10min), strength (8-10 exercises, 10-15 repetition), flexibility (10 mins) and balance/coordination activities tailored to each participant’s need and ability. An Accredited Exercise Physiologist will design and run exercise sessions during the study period, monitor fidelity to the program in coordination with an in-house physiotherapist and a research team member. A class session checklist will be used to assess participants' adherence to the program.

Our industry partner for this project is PresCare. PresCare provides care services including residential, in-home community care and chaplaincy and pastoral care in metropolitan and regional areas throughout Queensland. This pilot project will be undertaken at Vela – a 154-bed aged care facility located in Carina, Brisbane. Vela provides care to residents across three separate buildings: a 60 bed facility (block A); a 64 bed facility (block B); and, a 30-bed special care unit for those diagnosed with dementia.

Residents in block A will be offered the exercise program (i.e., intervention group) while residents in block B will receive usual care (i.e., the control group). The usual care group will receive standard care according to activities designed by the PresCare lifestyle team that include daily walks and Tai Chi.

We anticipate recruiting 60 participants to the study – 30 in the intervention group and 30 in the control. The intervention group will be classified according to the functional ability and / or capacity. An estimated 3 subgroups will be established with an average of 10 participants (i.e., 30 in total). Classification according to the functional ability and / or capacity will ensure that each participant’s exercise prescription is designed to provide optimal stimulus to the cardiorespiratory and neuromuscular systems while maximising safety, compliance and retention. Such a strategy will address the acceptability, effectiveness and sustainability of the exercise program.

The project will be officially launched in July 2018 (subject to ethics approval), at Vela, with an information session for Pres Care staff, residents and their families. This session will introduce the research team, project aims, roles, responsibilities, risks and research procedure. Interested participants will be provided with an information sheet. At the completion of the pilot project another information session will be held to provide participants and their families with results of the study.

At the commencement of the study, specific training will be provided to PresCare staff (exercise physiologist, lifestyle team, facility manager and other staff) on all facets of the exercise program from recruitment through to implementation, potential risks and strategies to mitigate these risks. The half-day training session will take place at Vela and will be conducted by Associate Investigator Associate Professor Prue Cormie who is an Accredited Exercise Physiologist with Exercise and Sport Science Australia.

After an initial information session, participants that express an interest in the study will discuss the exercise program with their GP at their next regular scheduled appointment. The GP will be required to determine if interested residents are physically and mentally fit to participate in the program. Residents, who are supported by their GP, will be asked to provide written consent to participate in the program. Prior to commencing the program and following its completion, participants will receive a one-on-one consultation with an accredited exercise physiologist lasting approximately one hour. These consultations will involve screening of health status, initial and progress assessments in order to individualise the exercise prescription to specific needs, physical abilities and personal preferences.

Objective measurements of physical function, resting blood pressure, height, weight, waist and hip circumferences occurs for all participants at pre- and post-program time points. Physical function will be assessed using the 400m walk and repeated chair rise tests and lower time taken to complete the tests representing higher functional performance. as a measure of cardiovascular fitness, peak oxygen consumption (VO2peak) will be estimated from the 400m walk test time and heart rate response. A validated oscillometric device or sphgomamometer will be used to record brachial blood pressure. Circumference measured using an anthropometric tape in accordance to standard protocols. These assessments will be performed in triplicate with the exception of the 400m test. Patient demographic and reported outcomes will be collected with a series of surveys with sound psychometric properties.
Intervention code [1] 298772 0
Prevention
Intervention code [2] 298794 0
Lifestyle
Comparator / control treatment
Control group: the usual or standard care according to activities designed by the PresCare lifestyle team that include daily walks and Tai Chi.
Control group
Active

Outcomes
Primary outcome [1] 306163 0
To measure quality of life utilising a sustainable intervention program in aged residential care. The screening instruments which will be utilised are AQoL-8D,
Timepoint [1] 306163 0
Baseline
3 months post intervention (primary endpoint)
6 months post intervention completion
Primary outcome [2] 306164 0
Any adverse events ( post intervention only) will be reported by the patient and recorded on an an Adverse Events Log. Adverse events to include any muscle strain, falls, pain as a direct result from the exercise intervention.
Timepoint [2] 306164 0
3 months post intervention (primary endpoint)
6 months post intervention completion
Secondary outcome [1] 347747 0
To measure cost effectiveness of the exercise intervention program. The following cost effectiveness data will be collected: - the cost of delivering the program obtained from notes held by the project manager; - the health care resource usage (admissions to hospital, ED presentations, number of falls) obtained from Prescare records; - Quality adjusted life years (QALYs) using AQoL- 8D instrument
Timepoint [1] 347747 0
3 months post intervention
6 months post intervention completion
Secondary outcome [2] 348579 0
Sustainability of the intervention - a qualitative measure that will be assessed via focus group discussions with EP, staff members and participants.
Timepoint [2] 348579 0
3 months post intervention
Secondary outcome [3] 348621 0
Transferability of the intervention to other Prescare sites as well as other RACFs - a qualitative measure that will be assessed via focus group discussions with EP, staff members and participants.
Timepoint [3] 348621 0
3 months post intervention

Eligibility
Key inclusion criteria
An Accredited Physiotherapist will determine if interested residents at Prescare Vela Aged Care Facility are physically and mentally fit to participate in the program in conjunction with the GP and the Facility Manager.
Minimum age
75 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Key exclusion criteria, persons less than 75 years of age

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A pilot pragmatic non-randomised controlled trial with alongside economic evaluation
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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)
QLD
Recruitment postcode(s) [1] 22748 0
4152 - Carina Heights

Funding & Sponsors
Funding source category [1] 297146 0
University
Name [1] 297146 0
Central Queensland University
Address [1] 297146 0
School of Health, Medical and Applied Sciences
160 Ann Street, Brisbane Qld 4000
Country [1] 297146 0
Australia
Primary sponsor type
University
Name
Central Queensland University
Address
School of Health, Medical and Applied Sciences
160 Ann Street, Brisbane Qld 4000
Country
Australia
Secondary sponsor category [1] 296158 0
None
Name [1] 296158 0
Address [1] 296158 0
Country [1] 296158 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298315 0
Central Queensland University Human Research Ethics Committee
Ethics committee address [1] 298315 0
CQUniversity Australia, Building 32, Bruce Highway
Rockhampton, Queensland  4702
Ethics committee country [1] 298315 0
Australia
Date submitted for ethics approval [1] 298315 0
19/07/2017
Approval date [1] 298315 0
10/04/2018
Ethics approval number [1] 298315 0
0000020697

Summary
Brief summary
Evidence suggests that levels of physical activity tend to decline in older ages and only one in four people over the age of 75 years and over are classified as sufficiently active against Australian national guidelines for physical activity. Our research aims to 1) develop and implement a sustainable exercise program, utilising the recent international recommendations for physical activity for older adults for Australians living in in residential aged care facilities to address physical and psychosocial problems proven to be amenable to exercise; 2) evaluate the acceptability, effectiveness (including cost-effectiveness), sustainability and transferability of the exercise program; and, 3) use the pilot results to develop an application for a NHRMC partnership project. Experimental research design will be used to achieve these aims. This study is a pilot pragmatic non-randomised controlled trial with alongside economic evaluation. Evaluation data will be collected using pre-/post intervention with a comparison group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76686 0
Dr Irina Kinchin
Address 76686 0
School of Health, Medical and Applied Sciences CQUniversity
Room 4.18 / WS 11, 160 Ann Street, Brisbane Qld 4000
Country 76686 0
Australia
Phone 76686 0
P +61 7 302 34114 | M +61 410 140 252
Fax 76686 0
61 7 30254114
Email 76686 0
i.kinchin@cqu.edu.au
Contact person for public queries
Name 76687 0
Ms Laura Adams
Address 76687 0
School of Health, Medical and Applied Sciences CQUniversity
Room 4.18 / WS 11, 160 Ann Street, Brisbane Qld 4000
Country 76687 0
Australia
Phone 76687 0
P +61 7 302 34114 | M +61 402990508
Fax 76687 0
61 7 30254114
Email 76687 0
i.kinchin@cqu.edu.au
Contact person for scientific queries
Name 76688 0
Dr Irina Kinchin
Address 76688 0
School of Health, Medical and Applied Sciences CQUniversity
Room 4.18 / WS 11, 160 Ann Street, Brisbane Qld 4000
Country 76688 0
Australia
Phone 76688 0
P +61 7 302 34114 | M +61 410 140 252
Fax 76688 0
61 7 30254114
Email 76688 0
i.kinchin@cqu.edu.au

No data has been provided for results reporting
Summary results
Not applicable