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Trial registered on ANZCTR


Registration number
ACTRN12620000733976
Ethics application status
Approved
Date submitted
8/06/2020
Date registered
13/07/2020
Date last updated
13/07/2020
Date data sharing statement initially provided
13/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise interveNtion outdoor proJect in the cOmmunitY (ENJOY) program in Dementia
Scientific title
Exercise interveNtion outdoor proJect in the cOmmunitY (ENJOY) -
ENJOY program for Independence in Dementia
Secondary ID [1] 301061 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 317118 0
Condition category
Condition code
Neurological 315279 315279 0 0
Dementias
Physical Medicine / Rehabilitation 315992 315992 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physical activity intervention - Participants from the intervention group will undergo 3 months supervised structured physical activity program using the Seniors Exercise Park outdoor equipment followed by a 3 months maintenance phase (unstructured independent exercise).

The Seniors Exercise Park - is 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 (walking on uneven surfaces, walking on a movable bridge), functional movement of walking up/down stairs, sit to stand. Example of the exercises can be found here: https://www.youtube.com/watch?v=PaYuCMtnlYk

Structured supervised 12 weeks exercise program:
Participants will undergo a 12-week supervised exercise intervention program twice a week using the seniors exercise park. 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 with the assistance of another supervisor (Aged Care staff; Physiotherapist/Diversional Therapist). Each session will consist of 5-7 minutes warm-up exercises, followed by 45-75 minutes on the equipment stations, and will conclude with 5-7 minutes of cool down exercises. The exercise classes will include 3-4 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.
The general exercise program structure will follow our previous published protocol (Levinger, P., et al., Exercise interveNtion outdoor proJect in the cOmmunitY for older people - the ENJOY Senior Exercise Park project translation research protocol. BMC Public Health, 2019. 19(1): p. 933), however given this is a feasibility study with a different clinical cohort, we anticipate modifications in the program and will be recording any variation.
Principle of exercise progression and intensity:
Week Number; Set Time; Rest Time
1 to 2; 60 seconds; 30-60 seconds to change over and rest
3 to 5; 60 seconds; less than or equal to 30 seconds change over and rest
6 to 9; 75 seconds; less than or equal to 30 seconds change over and rest
10 to 12; 90 seconds; less than or equal to 30 seconds change over and rest

Maintenance phase - Independent usage 12-24 weeks post baseline
After completion of the 12-week program, it is expected that participants will be familiar with the equipment and the exercises and therefore able to exercise more independently. Pre-scheduled sessions will be available for participants to access and use the Seniors Exercise Park under supervision (Physiotherapist/ Diversional Therapist staff from the facility, who are trained in using the equipment). To facilitate independence and empowerment, participants will be encouraged to exercise independently (supervised but unstructured sessions). Small exercise cards with graphic images will be placed in each exercise station to aid participants to progress through the stations.

Adherence - weekly attendance to both the structured supervised and maintenance phases will be monitored using attendance logs. The attendance logs will be recorded by the research staff.
Intervention code [1] 317364 0
Prevention
Comparator / control treatment
The control group will receive the standard care offered by the aged care facility. Participants from the control group will be given the opportunity to participate in organised recreation and leisure-based group activities such as art or music that are run by the Diversional Therapist staff at the aged care facility.
Control group
Active

Outcomes
Primary outcome [1] 323518 0
Feasibility including: recruitment and retention (% approached who agreed to participate and % of completion of the intervention)
Will be assessed based on review of study record e.g., attendance log
Timepoint [1] 323518 0
3 months and 6 months
Primary outcome [2] 323519 0
Physical activity program modifications and adaptations (e.g. exercise length, session duration) - will be assessed by review and audit of study record (forms)
Timepoint [2] 323519 0
3 months and 6 months
Primary outcome [3] 323520 0
Supervision needs (ratio of supervision to participants) - will be assessed by review and audit of study record (forms).
Timepoint [3] 323520 0
3 months and 6 months
Secondary outcome [1] 382130 0
Physical function measure - Functional lower limb muscle strength will be assessed using the five times sit to stand test
Timepoint [1] 382130 0
Baseline, 3 months, 6 months
Secondary outcome [2] 382131 0
Physical function measure - Exercise tolerance and functional mobility will be assessed using the two-minute walk test
Timepoint [2] 382131 0
Baseline, 3 months and 6 months
Secondary outcome [3] 382132 0
Physical function measure - Dynamic balance will be assessed using the Step test
Timepoint [3] 382132 0
Baseline, 3 months and 6 months
Secondary outcome [4] 382133 0
Physical function measure - Walking speed will be assessed using the 4 meters walk test
Timepoint [4] 382133 0
Baseline, 3 months and 6 months
Secondary outcome [5] 382134 0
Cognitive function will be assessed using The Montreal Cognitive Assessment (MoCA)
Timepoint [5] 382134 0
Baseline, 3 months and 6 months
Secondary outcome [6] 382135 0
Health-related quality of life will be assessed using the Quality of Life in Alzheimer's disease scale (QoL-AD)
Timepoint [6] 382135 0
Baseline, 3 months and 6 months
Secondary outcome [7] 382136 0
Health-related quality of life will be assessed using the EQ-5D-5L.
Timepoint [7] 382136 0
Baseline, 3 months and 6 months
Secondary outcome [8] 382137 0
Fear of falls will be assessed using the Iconographical Falls Efficacy Scale
Timepoint [8] 382137 0
Baseline, 3 months and 6 months
Secondary outcome [9] 382138 0
Loneliness will be assessed using the UCLA 3-Item Loneliness Scale
Timepoint [9] 382138 0
Baseline, 3 months and 6 months
Secondary outcome [10] 382139 0
Social isolation and social support will be assessed using the Lubben Social Network Scale
Timepoint [10] 382139 0
Baseline, 3 months and 6 months
Secondary outcome [11] 382140 0
Engagement with daily activity will be assessed by aged care staff using the Pool Activity Level (PAL)
Timepoint [11] 382140 0
Baseline, 3 months and 6 months
Secondary outcome [12] 382141 0
The Falls Risk Assessment Tool (FRAT) will be used to assess fall risk
Timepoint [12] 382141 0
Baseline, 3 months and 6 months
Secondary outcome [13] 382142 0
Mood - will be assessed using a five point likert scale using a visual smiley face card
Timepoint [13] 382142 0
At the beginning of each exercise session
Secondary outcome [14] 382143 0
Enjoyment - will be assessed using a five point likert scale enjoyment scale using a visual smiley
Timepoint [14] 382143 0
At the end of each exercise session
Secondary outcome [15] 382144 0
Motivation to participate will be assessed by the exercise supervisor their observation and interpretation of participants’ expression, verbal prompt and body language using a five point likert scale
Timepoint [15] 382144 0
At each exercise session
Secondary outcome [16] 382145 0
Engagement in the physical and social activity will be assessed using the Group Observational Measurement of Engagement (GOME) tool
Timepoint [16] 382145 0
At each exercise session
Secondary outcome [17] 382146 0
General motivation and engagement behavior will be assessed using a five-point Likert scale (from very negative to very positive)
Timepoint [17] 382146 0
At 5 time points: at the beginning of the structured physical activity program (week 1), half way through (week 6) and at the end (week 12), half way through the maintenance phase (week 18), at the completion of the maintenance phase (week 24).
Secondary outcome [18] 382147 0
Wandering behavior (walking off) will be documented by staff (description, duration and time occurred)
Timepoint [18] 382147 0
At each exercise session
Secondary outcome [19] 382148 0
Staff and participants feedback will be collected using a set of questions (survey)
Timepoint [19] 382148 0
At the completion the 12-week exercise intervention
Secondary outcome [20] 383984 0
PRIMARY OUTCOME - Feasibility - safety (combination falls and events as described below)
Safety will be assessed based on the following: any falls that occur during the exercise delivery sessions, any adverse events (joint/muscle pain during the exercise or as a result of the exercise sessions), serious adverse events (any report of difficulty breathing that does not settle quickly with rest, new or unrelenting chest pain, or acute changes in the level of consciousness during the session where a medical emergency procedure will be required).
Study record forms (recorded by staff) will be used to collect information around safety.
Timepoint [20] 383984 0
Throughout the overall 6 months exercise program
Secondary outcome [21] 383985 0
PRIMARY OUTCOME - Feasibility - Attendance and overall adherence (% number of sessions attended relative to total number of available sessions).
Will be assessed based on attendance logs (from the exercise sessions)
Timepoint [21] 383985 0
Throughout the 6 months exercise program

Eligibility
Key inclusion criteria
Older people will be included in the study if they meet the following inclusion criteria 1) aged 60 years old or over and reside at the aged care facility 2) have been diagnosed with mild to moderate dementia using the Standardised Mini-Mental State Examination (sMMSE more than 10) 3) are able to stand by themselves with/without hand support; 4) are able to walk without manual (physical) assistance from staff and 5) who are able to follow simple exercise instructions.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Older adults will be excluded from this study as follows: 1) Participants who are unable to stand by themselves with/without hand support; (2) unable to walk without manual (physical) assistance from staff (with or without walking aid) (3) unable to comprehend simple instructions during the exercise program (4) have severe dementia (Standardised Mini-Mental State Examination (sMMSE less than 10), (5) participants with terminal or unstable illness or chronic conditions, or any documented medical condition or physical impairment that is deemed by their medical practitioner to contraindicate their inclusion, will be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Block randomization will be undertaken using opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by dementia severity (moderate or mild) based on the Standardised Mini-Mental State Examination (moderate sMMSE more than 10 but less than 20; mild sMMSE between 20 -24).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data for the feasibility and safety components of the study will be analysed as follows: (mean, standard deviation and proportion): proportion of participants approached to participate who did commence the program, percentage of participants who complete the intervention, overall percentage of sessions attended, number of participants who dropout, any falls that occur during the exercise sessions, any muscle/joint pain during or after the exercise sessions, and serious adverse events requiring medical attention. Modifications of the exercise program will be reported and a recommended refined structure will be presented at the end of the program.

To determine statistical trends of effectiveness, analyses of the selected outcomes such as cognitive, physical function, quality of life and social measures will be performed to assess the changes within and between groups over time (pre/post). Therefore, repeated measures ANOVA with factors of intervention (Seniors Exercise Park, control) and time (pre-post intervention and follow-up) will be used. A post hoc analysis will be undertaken using the group differences and variability within groups on the secondary measures to determine the required sample size for a future adequately powered study using these outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/08/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 30044 0
3088 - St Helena

Funding & Sponsors
Funding source category [1] 305503 0
Other
Name [1] 305503 0
Alzheimer’s Association
Country [1] 305503 0
United States of America
Primary sponsor type
Other
Name
National Ageing Research Institute
Address
PO Box 2127, Royal Melbourne Hospital, Victoria 3050 Australia
Country
Australia
Secondary sponsor category [1] 305902 0
None
Name [1] 305902 0
Address [1] 305902 0
Country [1] 305902 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305815 0
Melbourne Health Ethics Committee
Ethics committee address [1] 305815 0
Ethics committee country [1] 305815 0
Australia
Date submitted for ethics approval [1] 305815 0
17/03/2020
Approval date [1] 305815 0
28/05/2020
Ethics approval number [1] 305815 0
HREC/61926/MH-2020

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

Contacts
Principal investigator
Name 101694 0
A/Prof Pazit Levinger
Address 101694 0
National Ageing Research Institute Ltd
PO Box 2127, Royal Melbourne Hospital, Victoria 3050 Australia
Country 101694 0
Australia
Phone 101694 0
+61412860804
Fax 101694 0
Email 101694 0
p.levinger@nari.edu.au
Contact person for public queries
Name 101695 0
Pazit Levinger
Address 101695 0
National Ageing Research Institute Ltd
PO Box 2127, Royal Melbourne Hospital, Victoria 3050 Australia
Country 101695 0
Australia
Phone 101695 0
+61412860804
Fax 101695 0
Email 101695 0
p.levinger@nari.edu.au
Contact person for scientific queries
Name 101696 0
Pazit Levinger
Address 101696 0
National Ageing Research Institute Ltd
PO Box 2127, Royal Melbourne Hospital, Victoria 3050 Australia
Country 101696 0
Australia
Phone 101696 0
+61412860804
Fax 101696 0
Email 101696 0
p.levinger@nari.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
No individual data be available due to ethics requirements, only group data be reported


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7670Study protocolA protocol paper will be submitted for publication. Once it has been accepted we will update the information on the registry  



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.