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Trial registered on ANZCTR


Registration number
ACTRN12617001545358
Ethics application status
Approved
Date submitted
10/10/2017
Date registered
7/11/2017
Date last updated
11/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of an Implementation Project - Exercise Prescription (EP) in Aged Care
Scientific title
Evaluation of an Implementation Project- Improving cognitive and functional capacity of older people with dementia in residential aged care through an exercise prescription approach (Exercise Evaluation)
Secondary ID [1] 292988 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognitive function 304896 0
physical function 304897 0
Dementia 304898 0
Condition category
Condition code
Mental Health 304218 304218 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 304219 304219 0 0
Dementias
Physical Medicine / Rehabilitation 304220 304220 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention being evaluated is a targeted and individually specific exercise physiologist-led intervention that includes one-to-one exercise prescription and group opportunities for exercise for residents in an aged care facility. Residents are free to engage in either or both opportunities. The intervention involves a 12-week control period, where normal activity occurs, then the 12-week intervention period, when the exercise program is implemented.

The one-to-one sessions were usually completed within the unit, or for some who are more able-bodied, in the gym. These sessions allowed tailoring of the exercises to appropriately challenge and specifically meet the needs of the individual, depending on their physical and cognitive abilities. This may have been asking residents to stand on one leg to challenge their balance in a controlled environment, or taking them through passive range of motion. There were attempts to incorporate some cardio-respiratory fitness using bike pedals, arm ergo or walking, resistance training using weights and therabands, balance training, coordination and cognition. Sessions occurred once a week, and lasted between 30 and 45 minutes, depending on the capacity of the individual.

The group sessions were generally completed in the lounge room or dining room of the unit. These sessions comprised of mostly seated exercises that were quite basic and suitable for majority of the participants. Residents followed along with an Exercise Physiologist (EP), or EP student, who demonstrated the exercises in front of the group, and encouraged the residents . Equipment such as dumbbells, wrist weights, ankle weights, therabands, and different sized balls were used to challenge the residents. These sessions were intended to be as fun, enjoyable and socially engaging as possible. During the intervention period these sessions ran twice a week for participating residents. Sessions were between 45 and 60 minutes in length, dependent on the circumstances on the day.

Where possible, the EPs also tried to challenge the residents cognitively throughout these sessions, whether this be encouraging them to count the repetitions aloud, or asking them to report, while exercising, how many fingers the EPs were holding up. Fidelity was not assessed; however, adherence was registered by the EPs, with a maximum attendance of 12 individual and 24 group sessions.

As evaluators, we are not responsible for the design or delivery of the exercise program. Instead, our evaluation seeks to measure the impact of the intervention on cognitive and functional factors.
Intervention code [1] 299231 0
Lifestyle
Comparator / control treatment
A 12-week period (only normal activity) before intervention commencement was used as the control period.
Control group
Active

Outcomes
Primary outcome [1] 303515 0
Whether the exercise program maintains or improves cognition for aged care residents who participate in the exercise intervention,

This will be assessed through the validated measure, the Addenbrooke Cognitive Exam (ACE III).
Timepoint [1] 303515 0
At baseline and 12-weeks later (primary timepoint).
Primary outcome [2] 303516 0
Whether exercise maintains or improves functional capacity for aged care residents who participate in the exercise intervention,

This will be assessed through validated measures, including the 5-rep sit-to-stand physical assessment.

Timepoint [2] 303516 0
At baseline and 12-weeks later (primary timepoint).
Primary outcome [3] 303517 0
Whether exercise maintains or improves functional capacity for aged care residents who participate in the exercise intervention,

This will be assessed using objective measurement from GENEActiv accelerometers (worn for a period of seven days), to provide a measure of total daily activity.
Timepoint [3] 303517 0
At baseline and 12-weeks later (primary timepoint).
Secondary outcome [1] 339158 0
Whether exercise maintains or improves wellbeing for aged care residents who participate in the exercise intervention,

This will be assessed through the validated measure, the AQOL.
Timepoint [1] 339158 0
At baseline and 12-weeks later.
Secondary outcome [2] 339212 0
Whether exercise has any impact on falls occurrence for aged care residents who participate in the exercise intervention,

This will be assessed through analyses of the organisation's falls data.
Timepoint [2] 339212 0
At baseline; and 24-weeks later.
Secondary outcome [3] 339213 0
Whether exercise has any impact on the amount of medication taken by aged care residents who participate in the exercise intervention,

This will be assessed through analyses of residents' medication data.
Timepoint [3] 339213 0
At baseline; and 24-weeks later.
Secondary outcome [4] 339884 0
Whether exercise influences sleep time.

This will be assessed using data extracted from the GENEActiv accelerometer (worn for a period of seven days).
Timepoint [4] 339884 0
Baseline and 12 weeks.

Eligibility
Key inclusion criteria
Any resident of the participating aged care facility is eligible to participate..
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no key exclusion criteria, including physical or mental conditions, for the evaluation of this exercise intervention.

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a pre-post study, with a 12-week control period (no intervention), followed by a 12-week intervention period.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
For this retrospective cluster randomised design, data was collected from participants from several wings of the aged care facility, in a staggered approach. Data was collected at three timepoints, each 12-weeks apart. Control data was timepoints one and two; intervention data timepoints two and three. Participants will be randomised as either control or intervention at the completion of data collection. This method/approach was adopted to in order to control for an order effect; a 12-week period could be associated with a decline in functional capacity in frail older adults.
It is important to have a wait-list control as exercise may maintain function/halt the decline in some of our outcome variables (e.g. cognition) rather than lead to positive change. This design will enable us to detect intervention effects and reduce contamination.
Power calculations on the primary outcome (functional performance) allow for 20% attrition. For a large effect, power of .8 and alpha set at P<0.05, 24 participants are required. Allowing for attrition at 20%, we require 27 participants per group (54 in total).
Data will be analysed using a random effects mixed model.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/12/2016
Date of last participant enrolment
Anticipated
Actual
29/09/2017
Date of last data collection
Anticipated
2/04/2018
Actual
16/04/2018
Sample size
Target
54
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 17632 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 297615 0
Government body
Name [1] 297615 0
National Health and Medical Research Council (NHMRC), Cognitive Decline Partnership Centre
Country [1] 297615 0
Australia
Funding source category [2] 297729 0
Government body
Name [2] 297729 0
Department of Social Services
Country [2] 297729 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471
Adelaide, South Australia 5001
Australia
Country
Australia
Secondary sponsor category [1] 296630 0
Commercial sector/Industry
Name [1] 296630 0
Helping Hand Organisation
Address [1] 296630 0
PO Box 66
North Adelaide SA 5006
Country [1] 296630 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298705 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 298705 0
Ethics committee country [1] 298705 0
Australia
Date submitted for ethics approval [1] 298705 0
08/09/2016
Approval date [1] 298705 0
27/10/2016
Ethics approval number [1] 298705 0
0000035728

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

Contacts
Principal investigator
Name 77958 0
A/Prof Gaynor Parfitt
Address 77958 0
University of South Australia (UniSA),
P7-08, Level 7, Playford Building
City East Campus
North Terrace, Adelaide, South Australia, 5000.
Country 77958 0
Australia
Phone 77958 0
+61 (08) 830 21212
Fax 77958 0
Email 77958 0
gaynor.parfitt@unisa.edu.au
Contact person for public queries
Name 77959 0
Gaynor Parfitt
Address 77959 0
University of South Australia (UniSA),
P7-08, Level 7, Playford Building
City East Campus
North Terrace, Adelaide, South Australia, 5000.
Country 77959 0
Australia
Phone 77959 0
+61 (08) 830 21212
Fax 77959 0
Email 77959 0
gaynor.parfitt@unisa.edu.au
Contact person for scientific queries
Name 77960 0
Gaynor Parfitt
Address 77960 0
University of South Australia (UniSA),
P7-08, Level 7, Playford Building
City East Campus
North Terrace, Adelaide, South Australia, 5000.
Country 77960 0
Australia
Phone 77960 0
+61 (08) 830 21212
Fax 77960 0
Email 77960 0
gaynor.parfitt@unisa.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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