Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000483651
Ethics application status
Approved
Date submitted
17/04/2023
Date registered
12/05/2023
Date last updated
2/06/2023
Date data sharing statement initially provided
12/05/2023
Date results provided
12/05/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Exercise Right for Active Ageing study
Scientific title
The Exercise Right for Active Ageing study: Engaging older adults in community-based exercise classes to improve physical function and physical activity levels.
Secondary ID [1] 309428 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ERAA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health-related decline with ageing 329683 0
Condition category
Condition code
Public Health 326581 326581 0 0
Health promotion/education
Physical Medicine / Rehabilitation 326832 326832 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Exercise for Active Ageing program consisted of 12 subsidised exercise classes, delivered by Accredited Exercise Scientists (AESs) and Accredited Exercise Physiologists (AEPs) employed within fitness centres, community health centres and private clinics at a frequency of one class per week, over a maximum period of 16 weeks. The specific content and delivery were at the discretion of the provider, provided classes were of low to moderate-intensity (intensity was monitored by the clients ability to talk during training, indicating low-moderate intensity exercise was being undertaken) exercise and suitable for older adults. Class types included falls prevention, strength, circuit and general fitness classes, amongst others. Classes were mostly delivered, in-person, at a community-based exercise facility or clinic, although during 2020-2021 pandemic lockdowns, online delivery options were also made available. Adherence to the program was monitored via attendance being marked on an online checklist each session and was incentivised via a subsidy program. Participants paid $7.27 excluding GST ($8.00 including GST) per 1hr class, with $9.92 (excluding GST) paid to the provider via project funding.
Intervention code [1] 325855 0
Lifestyle
Intervention code [2] 326033 0
Treatment: Other
Comparator / control treatment
There was no control group included. This was a pre-post intervention study where each client acted as their own control and comparisons were made between pre-post intervention, adherence, pandemic lockdown locations and class types.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334434 0
Lower limb strength and the ability to perform activities of daily living (ADLs) measured using the 30 second Sit-to-Stand (STS) test.

Jones CJ, et al. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999;70:113-119.
Timepoint [1] 334434 0
Pre- and post- intervention of 12 weeks of intervention
Primary outcome [2] 334435 0
Functional mobility and dynamic balance measured using the 3-metre Timed Up and Go (TUG) test

Podsiadlo D, et al. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991;39:142-148.
Timepoint [2] 334435 0
Pre- and post- intervention of 12 weeks of intervention
Primary outcome [3] 334469 0
Adherence to the program - number of classes attended across the 12 week, 1 class per week, program. Attendance was marked at each session via an online checklist system.
Timepoint [3] 334469 0
Measured across the program.
Secondary outcome [1] 420608 0
Grip strength (left and right) measured in kg using a hand grip dynamometer

Lacy A. Measurement and evaluation in physical education and exercise science. 6th ed. CA, USA: Pearson Benjamin Cummings; 2011.
Timepoint [1] 420608 0
Pre- and post- intervention of 12 weeks of intervention
Secondary outcome [2] 420609 0
Lower body flexibility measured using the chair Sit and Reach test (left and right)

Lacy A. Measurement and evaluation in physical education and exercise science. 6th ed. CA, USA: Pearson Benjamin Cummings; 2011.
Timepoint [2] 420609 0
Pre- and post- intervention of 12 weeks of intervention
Secondary outcome [3] 420610 0
Waist circumference measured using a tape measure at the narrowest point of the torso

American College of Sports Medicine. ACSM’s guidelines for exercise testing and prescription. 8th ed. China: Lippincott Williams and Wilkins; 2010.
Timepoint [3] 420610 0
Pre- and post- intervention of 12 weeks of intervention
Secondary outcome [4] 420810 0
This is assessed as a composite outcome. Physical activity levels and sedentary time measured using a self reported questionnaire consisting of five questions relating to the past week, assessing i) minutes spent walking continuously for ten minutes or more, and ii) participation in moderate- and iii) vigorous-intensity physical activity (MPA and VPA, respectively), iv) the total number of active days (i.e. spent walking or performing MPA or VPA); and v) average daily sitting time.

Lee PH, et al. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011;8:115.
Timepoint [4] 420810 0
Pre- and post- intervention of 12 weeks of intervention

Eligibility
Key inclusion criteria
Community-dwelling older adults from every state and territory of Australia, who completed a pre-intervention assessment and attended at least one class were eligible for inclusion. Individuals at a higher risk of an adverse event due to exercise were advised to seek guidance from an appropriate allied health professional or medical practitioner prior to participating in the study.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria included the inability to participate in a low to moderate-intensity exercise program, in accordance with the Adult Pre-Exercise Screening System (APSS) V2 (Stage 1).

Exercise & Sports Science Australia. Adult Pre-Exercise Screening System V2 ESSA. https://www.essa.org.au/Public/ABOUT_ESSA/Pre-Exercise_Screening_Systems.aspx. Published 2019. Accessed 17/1/23.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/08/2019
Date of last participant enrolment
Anticipated
Actual
30/06/2022
Date of last data collection
Anticipated
Actual
30/09/2022
Sample size
Target
8000
Accrual to date
Final
6626
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313623 0
Government body
Name [1] 313623 0
Australian Sports Commission (Better Ageing Grant)
Country [1] 313623 0
Australia
Primary sponsor type
Other
Name
Exercise & Sports Science Australia (ESSA)
Address
9 Hercules St, Hamilton QLD 4007
Country
Australia
Secondary sponsor category [1] 315447 0
None
Name [1] 315447 0
Address [1] 315447 0
Country [1] 315447 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312795 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 312795 0
Ethics committee country [1] 312795 0
Australia
Date submitted for ethics approval [1] 312795 0
Approval date [1] 312795 0
26/08/2019
Ethics approval number [1] 312795 0
Project ID: 21550

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

Contacts
Principal investigator
Name 125950 0
Dr Channa Marsh
Address 125950 0
Exercise & Sports Science Australia (ESSA)
9 Hercules St, Hamilton QLD 4007
Country 125950 0
Australia
Phone 125950 0
+61 0731713335
Fax 125950 0
Email 125950 0
[email protected]
Contact person for public queries
Name 125951 0
Channa Marsh
Address 125951 0
Exercise & Sports Science Australia (ESSA)
9 Hercules St, Hamilton QLD 4007
Country 125951 0
Australia
Phone 125951 0
+61 0731713335
Fax 125951 0
Email 125951 0
[email protected]
Contact person for scientific queries
Name 125952 0
Christina Ekegren
Address 125952 0
School of Primary and Allied Health Care, Monash University, Peninsula Campus, Frankston, VIC 3199
Country 125952 0
Australia
Phone 125952 0
+61 3 9904 4847
Fax 125952 0
Email 125952 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
EmbaseImpact of the Exercise Right for Active Ageing program on physical function in older adults: a quasi-experimental pre-post study.2023https://dx.doi.org/10.1186/s12877-023-04499-5
N.B. These documents automatically identified may not have been verified by the study sponsor.