ANZCTR - Registration

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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

2/02/2025

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Transition into residential aged care

Relocation stress

Frailty

Ageing

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Musculoskeletal

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]

Prevention

Intervention code [2]

Rehabilitation

Intervention code [3]

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]

Mental Well-Being - measured using the Warwick-Edinburgh Mental Well-being Scale

Timepoint [1]

The WEMWBS will be conducted at baseline and within 1 to 2 weeks following the end of the intervention.

Secondary outcome [1]

Belongingness will be measured using the General Belongingness scale (GBS)

Timepoint [1]

The GBS will be conducted at baseline and within 1 to 2 weeks following the end of the intervention.

Secondary outcome [2]

Physical assessment: 30 second Sit to Stand

Timepoint [2]

Baseline 6 weeks post intervention commencement 1 - 2 weeks following the end of the intervention

Secondary outcome [3]

Loneliness will be measured using the Three-item UCLA Loneliness scale

Timepoint [3]

The UCLA Loneliness Scale will be conducted at baseline and within 1 to 2 weeks following the end of the intervention.

Secondary outcome [4]

Physical assessment: Hand Grip Strength

Timepoint [4]

Baseline 6 weeks post intervention commencement 1 - 2 weeks following the end of the intervention

Secondary outcome [5]

Physical assessment: Timed Up and Go

Timepoint [5]

Baseline 6 weeks post intervention commencement 1 - 2 weeks following the end of the intervention

Secondary outcome [6]

Physical assessment: 4 Stage Balance Test

Timepoint [6]

Baseline 6 weeks post intervention commencement 1 - 2 weeks following the end of the intervention

Secondary outcome [7]

Physical assessment: 2-minute Walk Test

Timepoint [7]

Baseline 6 weeks post intervention commencement 1 - 2 weeks following the end of the intervention

Secondary outcome [8]

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]

Actigraph data will be collected at baseline and within 4 weeks following the end of the intervention.

Secondary outcome [9]

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]

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

Withdrawn

Reason for early stopping/withdrawal

Participant recruitment difficulties

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

6057 - High Wycombe

Funding & Sponsors

Funding source category [1]

University

Name [1]

Edith Cowan University

Address [1]

270 Joondalup Dr, Joondalup 6027 Perth WA

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Hall & Prior Health and Aged Care group

Address [2]

6-18 Mayfair Street West Perth 6005 Perth WA

Country [2]

Australia

Primary sponsor type

University

Name

Edith Cowan University

Address

270 Joondalup Dr,
Joondalup
6027
Perth
WA

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Hall & Prior Health and Aged Care group

Address [1]

6-18 Mayfair Street West Perth 6005 Perth WA

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

ECU Human Research Ethics Committee

Ethics committee address [1]

270 Joondalup Dr, 
Joondalup 
6027
Perth
WA

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/04/2021

Approval date [1]

03/08/2021

Ethics approval number [1]

2021-02323-SCOTT

Summary

Brief summary

Transitioning into residential aged care (RAC) can be a stressful period for some older adults. This study will investigate the effects of a physical activity (PA) program introduced to new residents within their first two weeks in RAC. In line with recommendations from the Royal Commission into Aged Care Quality and Safety to promote wellness and reablement among older adults, the aim of the study is to investigate the effect of an individually tailored PA intervention on the psychosocial and physical well-being of older adults who have recently transitioned into RAC. The exercise physiologist intervention will take place over 12 weeks and consist of both one-on-one and group exercise sessions. Participants will be recruited from a number of RAC facilities in Perth, Western Australia. The two-arm intervention will address the question: What is the effect of a prescribed exercise program on the psychosocial well-being of older adults transitioning into RAC, as measured by the Warwick-Edinburgh Mental Well-being Scale, the General Belongingness scale, and the Three-item UCLA Loneliness scale? It is anticipated that research findings will contribute to a more coordinated approach to wellness and reablement among older Australians and provide aged care providers with the evidence they need to replicate similar programs, especially during a time that is traditionally perceived as challenging for the resident.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mrs Stacey Scott

Address

Edith Cowan University School of Medical and Health Sciences 270 Joondalup Drive Joondalup 6027 Perth Western Australia

Country

Australia

Phone

+61 477539870

Fax

[email protected]

Contact person for public queries

Name

Stacey Scott

Address

Edith Cowan University School of Medical and Health Sciences 270 Joondalup Drive Joondalup 6027 Perth Western Australia

Country

Australia

Phone

+61 477539870

Fax

[email protected]

Contact person for scientific queries

Name

Stacey Scott

Address

Edith Cowan University School of Medical and Health Sciences 270 Joondalup Drive Joondalup 6027 Perth Western Australia

Country

Australia

Phone

+61 477539870

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Case by case basis at the discretion of the principle investigator and members of research team

Conditions for requesting access:
• -

What individual participant data might be shared?

• Outcome data

What types of analyses could be done with individual participant data?

• Any purpose

When can requests for individual participant data be made (start and end dates)?

From:
Data will be made available from the time of publication to 5 years after publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Via email from principle investigator
[email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Email
15995	Informed consent form	[email protected]
15996	Ethical approval	[email protected]
15997	Clinical study report	[email protected]

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.

Trial Review

Documents added manually

Documents added automatically