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Trial registered on ANZCTR


Registration number
ACTRN12615000458538
Ethics application status
Approved
Date submitted
16/03/2015
Date registered
11/05/2015
Date last updated
26/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Watermemories Swimming Club for People with Dementia: Cluster Randomised Controlled Trial
Scientific title
Cluster randomised controlled trial of an aquatic exercise program for people with dementia to reduce behavioural and psychological symptoms (BPSD)
Secondary ID [1] 286258 0
Nil known
Universal Trial Number (UTN)
U1111-1167-5895
Trial acronym
WSC (Cluster)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 294311 0
Condition category
Condition code
Neurological 294638 294638 0 0
Dementias
Physical Medicine / Rehabilitation 294637 294637 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be implemented over 12 weeks, post-intervention will assessment will be at 12 weeks and follow-up assessment will be completed at 26 weeks.

The Watermemories Swimming Club (WSC) is an established aquatic exercise intervention designed by a team which includes a gerontological exercise physiologist and dementia experts. This intervention targets resistance, balance, flexibility and aerobic training, and includes a warm up and cool down phase. Exercises include walking, marching and weight transfer, lower and upper body resistance activities. Following each session the intervention has a time allowance of up to 15 minutes for free swimming so participants can engage in laps, playing or relaxing. Specific exercises can be tapered to cater for both group and individual capacity. Sessions are delivered by experienced swimming instructors and in-pool assistants trained in the intervention delivery.

The Watermemories aquatic exercise intervention is designed to increase physical activity, improve health as well as enhance social, BPSD and affective outcomes. The need to increase physical activity in people with dementia is straight-forward. The beauty of swimming is that not only is accessible, simple, measurable, safe, non-invasive, inexpensive and enjoyable but it addresses the adverse physical effects of inactivity as well as having a significant impact on BPSD, psychological distress, anxiety and depression.

Water is a supportive environment ideal for people with arthritis and at risk of falls and importantly, offers resistance to maintain exercise progression and intensity. From the perspective of person-centered care, it is appropriate for people who have a history of aquatic exercise, or do not like, or are unable to partake in, common alternatives such as gym exercise, walking, dancing or gardening.

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.

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 attendance and adherence to the program can be monitored.

Intervention code [1] 291340 0
Rehabilitation
Intervention code [2] 291343 0
Behaviour
Comparator / control treatment
This is a cluster randomised controlled trial with whole of residential care facility (RACF) randomised either to control or intervention. Data will be aggregated and participants in the intervention condition will be compared to participants in the attention control condition. Participants in the control condition will be engaged in activities such as casual conversation, newspaper reading and/or craft activities for an equivalent amount of time over the 12 week period (ie. twice-weekly 45 minute sessions). These social groups will be facilitated by a diversional therapist in a common meeting area in the RACF. Therapeutically-oriented interaction such as reminiscence will be avoided.
Control group
Active

Outcomes
Primary outcome [1] 294464 0
Psychological well-being, as assessed by the Psychological Well-Being in Cognitively Impaired Persons test
Timepoint [1] 294464 0
Baseline (week 1), first follow-up post-intervention (week 12), and final follow-up (week 26).
Primary outcome [2] 294463 0
Behaviour and psychological symptoms of dementia, as assessed by the Revised Memory and Behaviour Checklist
Timepoint [2] 294463 0
Baseline (week 1), first follow-up post-intervention (week 12), and final follow-up (week 26).
Primary outcome [3] 294470 0
Functional capacity, assessed by the Balance Outcome Measure for Elder Rehabilitation (BOOMER) test
Timepoint [3] 294470 0
Baseline (week 1), first follow-up post-intervention (week 12), and final follow-up (week 26).
Secondary outcome [1] 313392 0
Functional capacity, as assessed by the Short Physical Performance Battery
Timepoint [1] 313392 0
Baseline (week 1), first follow-up post-intervention (week 12), and final follow-up (week 26).
Secondary outcome [2] 313388 0
Functional capacity, as assessed by the Index of Independence in Activities of Daily Living Evaluation Form
Timepoint [2] 313388 0
Baseline (week 1), first follow-up post-intervention (week 12), and final follow-up (week 26).
Secondary outcome [3] 313390 0
Anxiety, as assessed by the Geriatric Anxiety Inventory
Timepoint [3] 313390 0
Baseline (week 1), first follow-up post-intervention (week 12), and final follow-up (week 26).
Secondary outcome [4] 313393 0
Daily physical activity and ambulatory activities, as assessed by an Actigraph triaxial accelerometer activity monitor worn on the wrist of participants during waking hours for 7-day periods
Timepoint [4] 313393 0
Baseline (week 1), first follow-up post-intervention (week 12), and final follow-up (week 26).
Secondary outcome [5] 313389 0
Depression, as assessed by the Cornell Scale for Depression
Timepoint [5] 313389 0
Baseline (week 1), first follow-up post-intervention (week 12), and final follow-up (week 26).

Eligibility
Key inclusion criteria
Eligibility criteria for RACFs:
1. > 50 high care beds
2. > 40% residents with dementia
3. within 25 kms of Toowoomba CBD

Eligibility criteria for residents:
1. Past history of swimming or a desire to go 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
Exclusion criteria for residents:
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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Clustering will occur at the RACF level with randomisation by necessity occurring at this level in order to prevent contamination of results. Seven RACFs will be allocated as intervention RACFs and seven as control RACFs.
Participant enrollment begins with supplying information and meeting with RACF directors, staff, residents, families and medical practitioners to explain the benefits and safety features of the program. All resources to support these sessions have been developed and trialled in our pilot work. Written informed consent will be obtained from the participants or if required, their substitute decision maker, and assent is required from the person with dementia at all times for the duration of the project. Evidence of the participant’s medical fitness is required from their general medical practitioner. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation will occur via a random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
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 control group at baseline, at the conclusion of the 12 week intervention period, and 26 weeks post-intervention. Within-groups analyses will examine whether there are any changes in each group over time. Significance will be set at .05.
Sample size was calculated on the outcome psychological well-being, as measured by Psychological Well-Being in Cognitively Impaired Person (Burgener 1992) during the pilot study. Assuming a mean change between pre- and post-intervention of 4 points with a SD of 4.9 on a 33 point scale (scores range from 11-44). Using Cohen’s classification of effect size and assuming a moderate effect size, a two-sided p of 0.05 and a power of 80% require 24 participants in intervention and 24 in RACF usual care program. Allowing for a 52% attrition rate, final sample size is n=50 for the intervention group and n=50 for the control group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2015
Actual
Date of last participant enrolment
Anticipated
31/08/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 9368 0
4350 - Toowoomba

Funding & Sponsors
Funding source category [1] 290863 0
Government body
Name [1] 290863 0
The Queensland Department of Health
Country [1] 290863 0
Australia
Primary sponsor type
Individual
Name
A/Prof Christine Neville
Address
School of Nursing Midwifery and Social Work
The University of Queensland
Chamberlain Building
St Lucia Qld 4072
Country
Australia
Secondary sponsor category [1] 289555 0
Individual
Name [1] 289555 0
Dr Theresa Scott
Address [1] 289555 0
School of Nursing Midwifery and Social Work
The University of Queensland
Chamberlain Building
St Lucia Qld 4072
Country [1] 289555 0
Australia
Secondary sponsor category [2] 289554 0
Individual
Name [2] 289554 0
Professor Elizabeth Beattie
Address [2] 289554 0
School of Nursing
Queensland University of Technology
N Block, Floor 6, Victoria Park
KELVIN GROVE QLD 4059
Country [2] 289554 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292477 0
The University of Queensland Behavioural and Social Sciences Ethical Review Committee
Ethics committee address [1] 292477 0
Ethics committee country [1] 292477 0
Australia
Date submitted for ethics approval [1] 292477 0
Approval date [1] 292477 0
21/01/2015
Ethics approval number [1] 292477 0

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

Contacts
Principal investigator
Name 55298 0
A/Prof Christine Neville
Address 55298 0
The School of Nursing Midwifery and Social Work
The University of Queensland
Chamberlain Building
St Lucia Qld 4072
Country 55298 0
Australia
Phone 55298 0
61 7 3365 1843
Fax 55298 0
Email 55298 0
christine.neville@uq.edu.au
Contact person for public queries
Name 55299 0
Christine Neville
Address 55299 0
The School of Nursing Midwifery and Social Work
The University of Queensland
Chamberlain Building
St Lucia Qld 4072
Country 55299 0
Australia
Phone 55299 0
61 7 3365 1843
Fax 55299 0
Email 55299 0
christine.neville@uq.edu.au
Contact person for scientific queries
Name 55300 0
Christine Neville
Address 55300 0
The School of Nursing Midwifery and Social Work
The University of Queensland
Chamberlain Building
St Lucia Qld 4072
Country 55300 0
Australia
Phone 55300 0
61 7 3365 1843
Fax 55300 0
Email 55300 0
christine.neville@uq.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

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

Documents added automatically
No additional documents have been identified.