Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000503729
Ethics application status
Approved
Date submitted
2/05/2013
Date registered
7/05/2013
Date last updated
10/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Watermemories Swimming Club for People with Dementia
Scientific title
In adults with dementia, does participating in the Watermemories Swimming Club aquatic exercise program, compared to not participating, improve physical and psychological well-being?
Secondary ID [1] 282419 0
Nil
Universal Trial Number (UTN)
N/A
Trial acronym
WSC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 289012 0
Condition category
Condition code
Physical Medicine / Rehabilitation 289351 289351 0 0
Other physical medicine / rehabilitation
Neurological 289412 289412 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adults with dementia from residential aged care facilities (RACF) will be invited to participate in the Watermemories Swimming Club (WSC) intervention. After a facility has agreed to participate, a matching facility (with the same aged care service provider) will be purposefully selected to receive usual care. Unlike the facilities invited to participate in the WSC intervention, it will not be necessary for the matching facility to be located in close proximity to the aquatic centre.

The WSC intervention is an evidence-based aquatic exercise program specific to people with dementia, designed by Associate Professor Christine Neville and Professor Elizabeth Beattie, both experts in dementia, and Dr Tim Henwood, an expert in special population exercise prescription.

Adults in facilities participating in the WSC intervention will partake in the WSC program, after receiving consent from a substitute decision-maker and medical clearance from a GP. The program involves twice-weekly, 45 minute sessions over a 12 week period. The sessions will be delivered at two locations: the Griffith University Aquatic and Fitness Centre, Mt Gravatt, and the Milne Bay Aquatic and Fitness Centre, Toowoomba, by a trained swimming instructor (working on the side of the pool) who has experience instructing older people with disabilities. Adults will be accompanied in the pool by trained volunteers. In addition, the pool will have at least one life guard on duty and an exercise physiologist will regularly attend sessions to assist with supervision. A maximum of 10 adults with dementia will attend each session. At the beginning and conclusion of the 12 week period, all participants will receive physical and psychological assessments. Throughout the intervention period, a weekly attendance list will be generated by each facility so that participant attendence and adherence to the program can be monitored. The WSC intervention has been risk assessed and safely trialled in an earlier pilot study in Toowoomba, in 2011. (For information about the pilot study, please see the following publications: (1) Neville, C., et al. (2013). "Watermemories: a swimming club for adults with dementia." Journal of gerontological nursing 39(2): 21-25; (2) Henwood, T., et al. (2012). "The Watermemories Swim Club for people with dementia." Australasian Journal on Ageing. 31(S2): 13, 23-24, 41; (3) Neville, C., et al. (2012). "The Watermemories Swim Club for People with Dementia." Journal of Ageing and Physical Activity. 20(August): S8 - 10.)
Intervention code [1] 287054 0
Rehabilitation
Intervention code [2] 287055 0
Behaviour
Comparator / control treatment
Adults with dementia from residential aged care facilities (RACF) will be invited to participate in the Watermemories Swimming Club (WSC) intervention. After a facility has agreed to participate, a matching facility (with the same aged care service provider) will be purposefully selected to receive usual care. Unlike the facilities invited to participate in the WSC intervention, it will not be necessary for the matching facility to be located in close proximity to the aquatic centre.

Adults in facilities receiving usual care will be our control group and will continue on with their normal facility activities for 12 weeks. At the beginning and conclusion of the 12 week period, all participants will receive physical and psychological assessments.
Control group
Active

Outcomes
Primary outcome [1] 289460 0
Behaviour and psychological symptoms of dementia, as assessed by the Revised Memory and Behaviour Checklist

Timepoint [1] 289460 0
Baseline and at the conclusion of the 12 week period
Primary outcome [2] 289461 0
Psychological well-being, as assessed by the Psychological Well-Being in Cognitively Impaired Persons test
Timepoint [2] 289461 0
Baseline and at the conclusion of the 12 week period
Primary outcome [3] 289462 0
Functional capacity, assessed by the Balance Outcome Measure for Elder Rehabilitation (BOOMER) test
Timepoint [3] 289462 0
Baseline and at the conclusion of the 12 week period
Secondary outcome [1] 302538 0
Functional capacity, as assessed by the Index of Independence in Activities of Daily Living Evaluation Form
Timepoint [1] 302538 0
Baseline and at the conclusion of the 12 week period
Secondary outcome [2] 302539 0
Depression, as assessed by the Cornell Scale for Depression
Timepoint [2] 302539 0
Baseline and at the conclusion of the 12 week period
Secondary outcome [3] 302540 0
Anxiety, as assessed by the Geriatric Anxiety Inventory
Timepoint [3] 302540 0
Baseline and at the conclusion of the 12 week period
Secondary outcome [4] 302541 0
Pain, as assessed by the Pain Assessment in Advanced Dementia Scale (PAINAD)
Timepoint [4] 302541 0
Baseline and at the conclusion of the 12 week period
Secondary outcome [5] 302542 0
Functional capacity, as assessed by the Short Physical Performance Battery
Timepoint [5] 302542 0
Baseline and at the conclusion of the 12 week period
Secondary outcome [6] 302543 0
Muscle strength, as assessed by a hand grip strength test.
Timepoint [6] 302543 0
Baseline and at the conclusion of the 12 week period
Secondary outcome [7] 302544 0
Muscle, fat and body mass, as assessed by the Bioelectrical Impedance Analysis (BIA)
Timepoint [7] 302544 0
Baseline and at the conclusion of the 12 week period

Eligibility
Key inclusion criteria
1. Past history of swimming
2. Residing in a residential aged care facility (low or high care)
3. Diagnosis of dementia
4. Able to walk a minimum of 10 metres self-ambulating or with a walking cane or wheelie walker
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unstable or terminal illness
2. Wheel-chair or bed bound
3. Medications contradictory to exercise
4. Unable to obtain medical clearance from GP to participate
5. Unable to obtain substitute decision-maker consent

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)
RACFs will be matched according to their aged care service provider. Each matched pair of RACFs will receive either the WSC intervention or usual care, according the availability of facility resources to participate in the WSC intervention. Baseline measures will be conducted. If participants from a single RACF participating in the WSC intervention, decide they do not want to participate after baselines measures are conducted, they will instead, continue to receive usual care and will be considered as a control participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using standard statistical practices and using the SPSS statistical package. Between-groups analyses will be used to compare the WSC intervention group to the usual care group at baseline and at the conclusion of the 12 week period. Within-groups analyses will examine whether there are any changes in each group over time. Significance will be set at .05.

The sample size was determined by a number of factors pertinent to the proposed project. Factors included, time frame and catchment area available for the delivery of the program, feasibility of recruitment of clients with advanced dementia among residential aged care facilities, and budget restrictions. In this way, it was calculated based on the feasibility of the project within the constraint of the funding application more so than through a primary variable and expected change.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 287192 0
Charities/Societies/Foundations
Name [1] 287192 0
Alzheimer’s Australia (Qld) Inc
Alzheimer’s Australia Dementia Research Foundation Grant
Country [1] 287192 0
Australia
Primary sponsor type
Individual
Name
Dr Tim Henwood
Address
UQ / Blue Care Research & Practice Development Centre
56 Sylvan Rd
TOOWONG QLD 4066
Country
Australia
Secondary sponsor category [1] 285955 0
Individual
Name [1] 285955 0
A/Prof Christine Neville
Address [1] 285955 0
School of Nursing and Midwifery
The University of Queensland
Level 2, Building 12
UQ Ipswich Campus
Qld 4305
Country [1] 285955 0
Australia
Secondary sponsor category [2] 285956 0
Individual
Name [2] 285956 0
Prof Elizabeth Beattie
Address [2] 285956 0
School of Nursing
Queensland University of Technology
N Block, Floor 6, Victoria Park
KELVIN GROVE QLD 4059
Country [2] 285956 0
Australia
Other collaborator category [1] 277371 0
Individual
Name [1] 277371 0
Ms Chantelle Baguley
Address [1] 277371 0
UQ / Blue Care Research & Practice Development Centre
56 Sylvan Rd
TOOWONG QLD 4066
Country [1] 277371 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289186 0
University of Queenland Behavioural & Social Sciences Ethical Review Committee
Ethics committee address [1] 289186 0
Ethics committee country [1] 289186 0
Australia
Date submitted for ethics approval [1] 289186 0
Approval date [1] 289186 0
28/02/2013
Ethics approval number [1] 289186 0
2011000856

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

Contacts
Principal investigator
Name 39666 0
Dr Tim Henwood
Address 39666 0
UQ / Blue Care Research & Practice Development Centre
56 Sylvan Rd
TOOWONG QLD 4066
Country 39666 0
Australia
Phone 39666 0
+61 7 3720 5303
Fax 39666 0
Email 39666 0
[email protected]
Contact person for public queries
Name 39667 0
Chantelle Baguley
Address 39667 0
UQ / Blue Care Research & Practice Development Centre
56 Sylvan Rd
TOOWONG QLD 4066
Country 39667 0
Australia
Phone 39667 0
+61 7 3720 5620
Fax 39667 0
Email 39667 0
[email protected]
Contact person for scientific queries
Name 39668 0
Tim Henwood
Address 39668 0
UQ / Blue Care Research & Practice Development Centre
56 Sylvan Rd
TOOWONG QLD 4066
Country 39668 0
Australia
Phone 39668 0
+61 7 3720 5303
Fax 39668 0
Email 39668 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAquatic exercise for residential aged care adults with dementia: Benefits and barriers to participation.2017https://dx.doi.org/10.1017/S104161021700028X
N.B. These documents automatically identified may not have been verified by the study sponsor.