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Trial registered on ANZCTR


Registration number
ACTRN12618001727235
Ethics application status
Approved
Date submitted
14/10/2018
Date registered
19/10/2018
Date last updated
19/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The ENJOY trial - Exercise interveNtion outdoor proJect in the cOmmunitY
Scientific title
Exercise interveNtion outdoor proJect in the cOmmunitY
The ENJOY trial - active and healthy ageing in the Victorian communities using a novel outdoor exercise park
Secondary ID [1] 296056 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic conditions associated with physical inactivity 309607 0
Falls 309608 0
Condition category
Condition code
Injuries and Accidents 308843 308843 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo a 12 weeks structured supervised exercise program using the outdoor senior exercise park in their community center park, for twice a week. The exercise park equipment is an outdoor playground equipment specifically designed for older people to improve strength, balance, joint movements and mobility and function. It comprises multiple equipment stations that target specific function or movement (upper and lower limb) such as shoulder range of movement, static and dynamic balance, functional movement of walking up/down stairs, sit to stand.
Participants will perform exercises that focus on strength, balance, coordination, mobility and flexibility. The exercise park sessions will be provided two times a week (each class approximately 1 to 1.5 hours duration) and will be supervised by a qualified physiotherapist or an accredited exercise physiologist. Each session will consist of 5-10 minutes warm-up exercises, followed by 45-75 minutes on the equipment stations, and will conclude with 5-10 minutes of cool down exercises. The exercise classes will include 6-8 participants and will be circuit-based. A familiarisation session will be organised for each participant prior to commencement of the exercise program. The initial level of the exercise difficulty will be determined during the familiarisation session and will be tailored to the capabilities of the participant with the primary consideration of safety. To maximise social interaction and enjoyment, morning/afternoon tea will be organised following the exercise sessions.

At the completion of the structured supervised exercise program, participants will be offered two options to continue their exercise participation for another 6 months: exercise by themselves (independent use, free of charge) or attend supervised group exercise sessions (with a low cost $5-8 per session).

Intervention code [1] 312394 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307389 0
Physical activity level using the Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire
Timepoint [1] 307389 0
At baseline, 3 and 9 months [primary timepoint]
Secondary outcome [1] 351787 0
Functional lower limb muscle strength using - the 30-second sit to stand test
Timepoint [1] 351787 0
At baseline, 3 months and 9 months
Secondary outcome [2] 351790 0
Dynamic balance - using the Step test
Timepoint [2] 351790 0
At baseline, 3 months and 9 months
Secondary outcome [3] 351791 0
Walking speed - using the 4 meters walk test
Timepoint [3] 351791 0
At baseline, 3 months and 9 months
Secondary outcome [4] 351792 0
Health-related quality of life using the EQ-5D-5L
Timepoint [4] 351792 0
At baseline, 3 months, 9 months and 12 months
Secondary outcome [5] 351793 0
Mental wellbeing - using the five-item World Health Organisation (WHO-5) Welbeing questionnaire
Timepoint [5] 351793 0
At baseline, 3 months and 9 months
Secondary outcome [6] 351794 0
Loneliness - using the UCLA 3-Item Loneliness Scale
Timepoint [6] 351794 0
At baseline, 3 months and 9 months
Secondary outcome [7] 351795 0
Depression - using the short version Geriatric Depression Scale (GDS-15)
Timepoint [7] 351795 0
At baseline, 3 months and 9 months
Secondary outcome [8] 351796 0
Fear of falls - using The Short Falls Efficacy Scale International
Timepoint [8] 351796 0
At baseline, 3 months and 9 months
Secondary outcome [9] 351797 0
Self-efficacy barriers to exercise - using The Self-Efficacy for Exercise (SEE)
Timepoint [9] 351797 0
At baseline, 3 months and 9 months
Secondary outcome [10] 351798 0
Enjoyment - using the 8 item version Physical Activity Enjoyment Scale (PACES)
Timepoint [10] 351798 0
At baseline, 3 months and 9 months
Secondary outcome [11] 351799 0
Social isolation and social support - using the Lubben Social Network Scale
Timepoint [11] 351799 0
At baseline, 3 months and 9 months
Secondary outcome [12] 351800 0
Falls risk - using The Falls Risk for Older People in the Community (FROP-Com)
Timepoint [12] 351800 0
At baseline, 3 months and 9 months
Secondary outcome [13] 351801 0
Falls surveillance - using monthly falls calendars
Timepoint [13] 351801 0
Each month for 12 months post-baseline
Secondary outcome [14] 351803 0
Productivity in paid and unpaid labour - using The iMTA Productivity Cost Questionnaire
Timepoint [14] 351803 0
At baseline and 12 months
Secondary outcome [15] 351804 0
Self reported allied health and community service use - using study-specific questionnaire
Timepoint [15] 351804 0
At baseline, 3 months, 9 months and 12 months
Secondary outcome [16] 351805 0
Participants’ feedback and satisfaction surveys designed specifically for this study
Timepoint [16] 351805 0
At 3 and 9 months post baseline
Secondary outcome [17] 351806 0
Participation rate (adherence) and exercise monitor - using daily attendance logs and individual fob key access
Timepoint [17] 351806 0
On a weekly basis from commencement of the intervention for 9 months
Secondary outcome [18] 351807 0
Health care utilisation costs - using Medicare and Pharmaceutical Benefits Scheme database extractions
Timepoint [18] 351807 0
Data will be extracted for a period of 18 months for each participant - 6 months prior to baseline assessment, and the 12 months following the baseline.

Eligibility
Key inclusion criteria
1) aged 60 years old and over living in the community
2) have had one or more falls in the previous 12 months or are concerned about having a fall
3) are generally independent around the house (able to take care of themselves) and in the community (e.g. able to walk away from home to visit local stores, friends, and other local venues) and who are able to attend the outdoor exercise park
4) using no walking aid (such as walking frames) or with no more than a single point stick used for regular outdoors walking;
5) no cognitive impairment (Abbreviated Mental Test Score >7/10).
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Have neurological or musculoskeletal conditions impacting on mobility
• A cognitive impairment as determined by the Abbreviated Mental Test Score of less than 7/10,
• Are currently taking part in a structured resistance training and or balance training program more than once a week
• Are physically active (do 150 minutes of physical activity / week)
• Using walking frame and have limited mobility
• Any documented medical condition deemed by the medical practitioner to contraindicate their inclusion

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
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
Efficacy
Statistical methods / analysis
For the primary outcome of overall physical activity score and the physical, mental, and health outcome measures, regression analyses with data clustered within individual participant will be used to determine if there are differences between scores collected at the baseline assessment and those collected at the 9 month follow-up. Moreover, repeated measures analysis of variance will also be used to examine the effect of the exercise program on physical activity level, physiological, mental, psychosocial and health outcomes between the other time point (baseline, 3 months, 12 months). Information collected about park usage, participants feedback and exercise adherence will be reported using descriptive statistics (frequency of usage, % of adherence). The outcome variables will be assessed for normality prior to analysis and transformed accordingly. Data will be analysed using SPSS version 25.0 (IBM Corp, NY, USA). Multiple imputation will be used to account for missing data at the 9 month follow-up assessment.

The economic evaluation will take the form of a cost-utility analysis taken from the societal perspective over a 6 month pre intervention vs 6 month post intervention time-horizon. This analysis will estimate the cost per quality adjusted life year gained from providing the exercise park intervention and guided exercise program (incorporating the optional continuation of the guided program). Change in quality adjusted life will be modelled using data from EQ-5D-5L utility instrument scores collected at baseline, and 12 month assessments. Health care costs will be measured using Medicare and Pharmaceutical Benefits Scheme database extraction.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/10/2018
Actual
Date of last participant enrolment
Anticipated
19/10/2020
Actual
Date of last data collection
Anticipated
18/10/2021
Actual
Sample size
Target
113
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 300643 0
Charities/Societies/Foundations
Name [1] 300643 0
Gandel Philanthropy
Country [1] 300643 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
National Ageing Research Institute
Address
National Ageing Research Institute Ltd
PO Box 2127, Royal Melbourne Hospital, Victoria 3050 Australia
Country
Australia
Secondary sponsor category [1] 300505 0
None
Name [1] 300505 0
Address [1] 300505 0
Country [1] 300505 0
Other collaborator category [1] 280348 0
Government body
Name [1] 280348 0
Whittlesea City Council
Address [1] 280348 0
Shop MM9, 1st Floor, Westfield Plenty Valley, 415 McDonalds Rd, Mill Park VIC 3082
Country [1] 280348 0
Australia
Other collaborator category [2] 280349 0
Government body
Name [2] 280349 0
Wyndham City Council
Address [2] 280349 0
45 Princes Highway (PO Box 197), Werribee VIC 3030
Country [2] 280349 0
Australia
Other collaborator category [3] 280350 0
Charities/Societies/Foundations
Name [3] 280350 0
Old Colonists' Association of Victoria
Address [3] 280350 0
Leith Park
339 St Helena Rd, St Helena, VIC 3088, Australia
Country [3] 280350 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301432 0
Melbourne Health Human Research Ethics Committee [EC00243]
Ethics committee address [1] 301432 0
Ethics committee country [1] 301432 0
Australia
Date submitted for ethics approval [1] 301432 0
03/07/2018
Approval date [1] 301432 0
06/09/2018
Ethics approval number [1] 301432 0
HREC/18/MH/286. Site Reference Number: 2018.238

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

Contacts
Principal investigator
Name 86974 0
A/Prof Pazit Levinger
Address 86974 0
National Ageing Research Institute Ltd
PO Box 2127, Royal Melbourne Hospital, Victoria 3050 Australia
Country 86974 0
Australia
Phone 86974 0
+61 3 8387 2626
Fax 86974 0
Email 86974 0
p.levinger@nari.edu.au
Contact person for public queries
Name 86975 0
Pazit Levinger
Address 86975 0
National Ageing Research Institute Ltd
PO Box 2127, Royal Melbourne Hospital, Victoria 3050 Australia
Country 86975 0
Australia
Phone 86975 0
+61 3 8387 2626
Fax 86975 0
Email 86975 0
p.levinger@nari.edu.au
Contact person for scientific queries
Name 86976 0
Pazit Levinger
Address 86976 0
National Ageing Research Institute Ltd
PO Box 2127, Royal Melbourne Hospital, Victoria 3050 Australia
Country 86976 0
Australia
Phone 86976 0
+61 3 8387 2626
Fax 86976 0
Email 86976 0
p.levinger@nari.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

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