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Trial registered on ANZCTR


Registration number
ACTRN12615000662561
Ethics application status
Approved
Date submitted
28/05/2015
Date registered
25/06/2015
Date last updated
27/11/2018
Date data sharing statement initially provided
27/11/2018
Date results provided
27/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects and Feasibility of a Physical Exercise Intervention for Individuals Living with a Dementia in Nursing Homes
Scientific title
In individuals living with a dementia in nursing homes, is a physiotherapist led physical exercise intervention feasible and more effective than usual care in reducing agitation levels and improving physical performance?
Secondary ID [1] 286043 0
Nil
Universal Trial Number (UTN)
U1111-1166-4780
Trial acronym
PED Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 294021 0
Condition category
Condition code
Physical Medicine / Rehabilitation 294322 294322 0 0
Physiotherapy
Neurological 295517 295517 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Physiotherapist led, structured physical exercise (PE) intervention consisting of a circuit of exercises targeting strength, balance and endurance for up to 5 participants + usual care for a 12 week period. The PE intervention will consist of exercises in sitting and/or standing, dependent on the individual's capabilities. Suitable exercises will be individualised and determined by physiotherapist leading the PE intervention.

Arm 1: PE intervention delivered for 45 minutes x 1 times per week plus usual care for 30 minutes x 4 times per week (weekly total duration 165 minutes) for 12 weeks

Arm 2: PE intervention delivered for 15 minutes x 3 times per week plus usual care 30 minutes x 4 times per week (weekly total duration 165 minutes) for 12 weeks
Intervention code [1] 291031 0
Treatment: Other
Intervention code [2] 292043 0
Behaviour
Intervention code [3] 292044 0
Lifestyle
Comparator / control treatment
Comparator/ control: Usual care of non-specialist recreational physical activities undertaken at the nursing home where the participants live such as, seated exercise classes, carpet bowls and bingo for up to 50 participants.

Usual care: 30 minutes x 4 times per week (weekly total duration 120 minutes)
Control group
Active

Outcomes
Primary outcome [1] 294122 0
Agitation levels

Cohen-Mansfield Agitation Inventory
Timepoint [1] 294122 0
T1: Baseline (week 0)
T2: During final two weeks of intervention (week 11 and 12)
Secondary outcome [1] 312557 0
Lower limb function, mobility and balance

Timed up and go test
Timepoint [1] 312557 0
T1: Baseline (week 0)
T2: Post-intervention (week 13)
Secondary outcome [2] 312872 0
Mobility and gait speed

Six metre walk test
Timepoint [2] 312872 0
T1: Baseline (week 0)
T2: Post-intervention (week 13)
Secondary outcome [3] 312873 0
Lower limb strength and dynamic balance

Five time sit to stand test
Timepoint [3] 312873 0
T1: Baseline (week 0)
T2: Post-intervention (week 13)
Secondary outcome [4] 314865 0
Functional balance and stability

(Modified) functional reach test
Timepoint [4] 314865 0
T1: Baseline (week 0)
T2: Post-intervention (week 13)
Secondary outcome [5] 314866 0
Lower limb strength and function

Timed static pedalling
Timepoint [5] 314866 0
T1: Baseline (week 0)
T2: Post-intervention (week 13)
Secondary outcome [6] 326326 0
Number of falls, which was reported through the incident form log by nursing staff.
Timepoint [6] 326326 0
T1: 12 weeks prior to start of intervention T2: 12 weeks during the intervention
Secondary outcome [7] 326327 0
Feasibility and satisfaction of the physical exercise intervention, assessed by interviews with family and staff.
Timepoint [7] 326327 0
T1: Post-intervention (week 13)

Eligibility
Key inclusion criteria
Participant characteristics:

- Living with a dementia (recorded in clinical documentary notes for a potential participant)
- Living in a nursing home permanently
- Physically able to participate in PE intervention
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participant characteristics:

- No record of living with a dementia (recorded in clinical documentary notes for a potential participant)
- Not living in a nursing home permanently
- Physically unable to participate in the PE intervention

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)
A researcher independent from the study will randomise the participants using a randomised number generated table.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomised number table generated from the 'random.org' web page on the World Wide Web(1).

1. Randomness and Integrity Services Limited. Random.org Random Number Service 2015 [15/02/2015]. Available from: www.random.org/.
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
A power calculation was completed that determined between 8 and 63 participants were required to show statistically significant differences between the groups. However, due to the discrepancy it was decided Cohen's effect size estimations would be used to determine the sample size instead. To show a large effect size (80% power) 26 participants were required in each group (78 participants in total). The type 1 error rate was set at 5%.

Primary outcome measure: Agitation levels (Cohen-Mansfield Agitation Inventory): ANOVA

Seconday outcome measures: Physical performance (Timed up an go test, six metre walk test, five time sit to stand test, (modified) functional reach test, timed static pedalling and number of falls): Chi Square and Kruskall Wallis Test. Interviews with family and staff: NVivo.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/03/2015
Actual
1/04/2015
Date of last participant enrolment
Anticipated
24/04/2015
Actual
26/04/2015
Date of last data collection
Anticipated
7/08/2015
Actual
13/08/2015
Sample size
Target
78
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 9147 0
5165 - Christies Beach
Recruitment postcode(s) [2] 9347 0
5245 - Hahndorf

Funding & Sponsors
Funding source category [1] 290632 0
University
Name [1] 290632 0
University of Wollongong
Country [1] 290632 0
Australia
Primary sponsor type
Individual
Name
Lindsey Brett
Address
C/O Associate Professor Victoria Traynor
School of Nursing
University of Wollongong
Northfields Avenue
Wollongong
NSW 2522
Country
Australia
Secondary sponsor category [1] 289324 0
University
Name [1] 289324 0
University of Wollongong
Address [1] 289324 0
C/O Associate Professor Victoria Traynor
School of Nursing
University of Wollongong
Northfields Avenue
Wollongong
NSW 2522
Country [1] 289324 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292265 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Social Science Human Resource
Ethics committee address [1] 292265 0
Ethics committee country [1] 292265 0
Australia
Date submitted for ethics approval [1] 292265 0
30/10/2014
Approval date [1] 292265 0
04/03/2015
Ethics approval number [1] 292265 0
EC00294

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

Contacts
Principal investigator
Name 54386 0
Dr Lindsey Brett
Address 54386 0
Australian Institute of Health Innovation
Level 6, Talavera Road
Macquarie University
NSW 2109
Country 54386 0
Australia
Phone 54386 0
+61 2 9850 2487
Fax 54386 0
Email 54386 0
lindsey.brett@mq.edu.au
Contact person for public queries
Name 54387 0
Lindsey Brett
Address 54387 0
Australian Institute of Health Innovation
Level 6, Talavera Road
Macquarie University
NSW 2109
Country 54387 0
Australia
Phone 54387 0
+61 2 9850 2487
Fax 54387 0
Email 54387 0
lindsey.brett@mq.edu.au
Contact person for scientific queries
Name 54388 0
Lindsey Brett
Address 54388 0
Australian Institute of Health Innovation
Level 6, Talavera Road
Macquarie University
NSW 2109
Country 54388 0
Australia
Phone 54388 0
+61 2 9850 2487
Fax 54388 0
Email 54388 0
lindsey.brett@mq.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
as per consent form


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.