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Trial registered on ANZCTR


Registration number
ACTRN12622000795796
Ethics application status
Approved
Date submitted
12/05/2022
Date registered
6/06/2022
Date last updated
13/07/2022
Date data sharing statement initially provided
6/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of physical activity on the lives of older adults who are making the transition into residential aged care
Scientific title
An investigation into how physical activity affects the lives of older adults during the transition process from Independent living to residential aged care
Secondary ID [1] 306937 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transition into residential aged care 326047 0
Relocation stress 326048 0
Frailty 326049 0
Ageing 326357 0
Condition category
Condition code
Mental Health 323354 323354 0 0
Depression
Mental Health 323355 323355 0 0
Anxiety
Physical Medicine / Rehabilitation 323356 323356 0 0
Other physical medicine / rehabilitation
Musculoskeletal 323357 323357 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transition into Residential Aged Care (Tri-RAC)
Equipment used: balls, free weights, resistance bands
A physical activity exercise program that includes strength, flexibility/mobility and balance exercises. Additional activities may include walking, playing ball games and dancing.
The physical activity sessions will be delivered by an Accredited Exercise Physiologist
The physical activity program will consist of both 1:1 face to face sessions, as well as group sessions.
The participant will receive 2 sessions per week for 12 weeks.
Each session will be 30-40 minutes in duration and of low to moderate intensity.
The sessions will take place within a residential aged care facility at various locations, such as the participant's room, a communal lounge area and outside in the garden.
The physical activity program will be individualised for each participant, taking into account their functional ability, if they walk with or without an aid, what they enjoy doing, and safety. Exercises will be modified according the each participant's abilities and the area that will provide them with the most benefit (E.g., if their legs are weak and they are unable to stand up unaided, the exercises will focus mostly on lower limb strength).
Adherence will be noted with the use of a simple attendance sheet.

An example of exercises: bicep curls, tricep extensions, shoulder and chest press, sit-to-stand, knee extension, neck range of motion, seated rows, standing marching, weight shifting, calf raises.

Intervention code [1] 323380 0
Prevention
Intervention code [2] 323382 0
Rehabilitation
Intervention code [3] 323558 0
Treatment: Other
Comparator / control treatment
Control: no treatment provided, continue with usual care - i.e., Participants do not receive any exercise instruction from an exercise physiologist. Participants are free to participate in any activities offered by the facility, except for the group exercise classes led by the EP.
Control group
Active

Outcomes
Primary outcome [1] 331090 0
Mental Well-Being - measured using the Warwick-Edinburgh Mental Well-being Scale
Timepoint [1] 331090 0
The WEMWBS will be conducted at baseline and within 1 to 2 weeks following the end of the intervention.
Secondary outcome [1] 408722 0
Belongingness will be measured using the General Belongingness scale (GBS)
Timepoint [1] 408722 0
The GBS will be conducted at baseline and within 1 to 2 weeks following the end of the intervention.
Secondary outcome [2] 408723 0
Physical assessment: 30 second Sit to Stand
Timepoint [2] 408723 0
Baseline
6 weeks post intervention commencement
1 - 2 weeks following the end of the intervention
Secondary outcome [3] 409739 0
Loneliness will be measured using the Three-item UCLA Loneliness scale
Timepoint [3] 409739 0
The UCLA Loneliness Scale will be conducted at baseline and within 1 to 2 weeks following the end of the intervention.
Secondary outcome [4] 409740 0
Physical assessment: Hand Grip Strength
Timepoint [4] 409740 0
Baseline
6 weeks post intervention commencement
1 - 2 weeks following the end of the intervention
Secondary outcome [5] 409741 0
Physical assessment: Timed Up and Go
Timepoint [5] 409741 0
Baseline
6 weeks post intervention commencement
1 - 2 weeks following the end of the intervention
Secondary outcome [6] 409742 0
Physical assessment: 4 Stage Balance Test
Timepoint [6] 409742 0
Baseline
6 weeks post intervention commencement
1 - 2 weeks following the end of the intervention
Secondary outcome [7] 409743 0
Physical assessment: 2-minute Walk Test
Timepoint [7] 409743 0
Baseline
6 weeks post intervention commencement
1 - 2 weeks following the end of the intervention
Secondary outcome [8] 409744 0
Actigraph data will be collected for 7 days to measure physical activity levels in terms of the average amount of time (in minutes) spent being sedentary, in light physical activity, moderate physical activity and vigorous physical activity during a 7-day period.
Timepoint [8] 409744 0
Actigraph data will be collected at baseline and within 4 weeks following the end of the intervention.
Secondary outcome [9] 410302 0
Actigraph data will be collected for 7 days to measure sleep period in terms of average Total Sleep Time in minutes over a 7-day period.
Timepoint [9] 410302 0
Actigraph data will be collected at baseline and within 4 weeks following the end of the intervention.

Eligibility
Key inclusion criteria
A permanent resident in residential aged care facility for 2 weeks or less
No or mild cognitive impairment
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Residents who are on respite or have moderate or severe cognitive impairment
Residents who cannot speak English

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)
Randomisation using computer software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All data collected will be of a longitudinal nature and therefore a repeated measures analysis will be used, treating time as a continuous variable. Due to the likelihood of participant drop out, missing data, unbalanced groups, and violation of sphericity assumptions, a Generalised Linear Mixed Model (GLMM) will be used to analyse the data. In the GLMM, participants will be the random effect and other variables, such as intervention group, age and gender will be the fixed effects. The level of significance is set at 0.05. Explanatory variables will include intervention group, time, age and gender. Covariates, which may affect the response variables and therefore need to be adjusted for will be the age and gender of the participants, and the participant’s pathway into RAC

The sample size was calculated using G-power (Faul et al., 2009) and is based on the Warwick-Edinburgh Mental Well-being Scale (Tennant et al., 2007). An a-priori power analysis using the mean and standard deviation found a sample size of 12 would be required to obtain statistically significant change with a moderate effect size, 1 – ß = 0.80 and alpha = 0.05. Initial sample size of 30 will be used to account for an expected 20% dropout.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/07/2022
Actual
Date of last participant enrolment
Anticipated
5/12/2022
Actual
Date of last data collection
Anticipated
28/04/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 37355 0
6102 - Bentley
Recruitment postcode(s) [2] 37356 0
6057 - High Wycombe

Funding & Sponsors
Funding source category [1] 311254 0
University
Name [1] 311254 0
Edith Cowan University
Country [1] 311254 0
Australia
Funding source category [2] 311256 0
Commercial sector/Industry
Name [2] 311256 0
Hall & Prior Health and Aged Care group
Country [2] 311256 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Dr,
Joondalup
6027
Perth
WA
Country
Australia
Secondary sponsor category [1] 312612 0
Commercial sector/Industry
Name [1] 312612 0
Hall & Prior Health and Aged Care group
Address [1] 312612 0
6-18 Mayfair Street
West Perth
6005
Perth
WA
Country [1] 312612 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310769 0
ECU Human Research Ethics Committee
Ethics committee address [1] 310769 0
Ethics committee country [1] 310769 0
Australia
Date submitted for ethics approval [1] 310769 0
08/04/2021
Approval date [1] 310769 0
03/08/2021
Ethics approval number [1] 310769 0
2021-02323-SCOTT

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

Contacts
Principal investigator
Name 118794 0
Mrs Stacey Scott
Address 118794 0
Edith Cowan University
School of Medical and Health Sciences
270 Joondalup Drive
Joondalup
6027
Perth
Western Australia
Country 118794 0
Australia
Phone 118794 0
+61 477539870
Fax 118794 0
Email 118794 0
sscott10@our.ecu.edu.au
Contact person for public queries
Name 118795 0
Stacey Scott
Address 118795 0
Edith Cowan University
School of Medical and Health Sciences
270 Joondalup Drive
Joondalup
6027
Perth
Western Australia
Country 118795 0
Australia
Phone 118795 0
+61 477539870
Fax 118795 0
Email 118795 0
sscott10@our.ecu.edu.au
Contact person for scientific queries
Name 118796 0
Stacey Scott
Address 118796 0
Edith Cowan University
School of Medical and Health Sciences
270 Joondalup Drive
Joondalup
6027
Perth
Western Australia
Country 118796 0
Australia
Phone 118796 0
+61 477539870
Fax 118796 0
Email 118796 0
sscott10@our.ecu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Outcome data
When will data be available (start and end dates)?
Data will be made available from the time of publication to 5 years after publication
Available to whom?
Case by case basis at the discretion of the principle investigator and members of research team
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Via email from principle investigator
sscott10@our.ecu.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15995Informed consent form  sscott10@our.ecu.edu.au
15996Ethical approval  sscott10@our.ecu.edu.au
15997Clinical study report  sscott10@our.ecu.edu.au



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.