Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623000964617
Ethics application status
Approved
Date submitted
17/08/2023
Date registered
6/09/2023
Date last updated
23/06/2024
Date data sharing statement initially provided
6/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A combined Face-to-face and Telehealth Home-based Exercise Program for Older People with Dementia in Indonesia
Scientific title
The Feasibility of a Combined Face-to-face and Telehealth Home-based Otago Exercise Program for Older People with Dementia in Indonesia
Secondary ID [1] 310359 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 331093 0
Condition category
Condition code
Neurological 327879 327879 0 0
Dementias
Physical Medicine / Rehabilitation 328060 328060 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants with dementia will participate in an individualised (tailored) home-based exercise program, delivered by a physiotherapist (with minimum 5 years’ experience). This exercise program is based on an existing home exercise program (the Otago program, https://www.livestronger.org.nz/assets/Uploads/acc1162-otago-exercise-manual.pdf). Exercise participation will be encouraged and monitored for safety through the carer, who will be trained by the physiotherapist (adapting the approach and resources used by Sari YM, Burton E, Lee D-CA, Hill KD. A Telehealth Home-Based Exercise Program for Community-Dwelling Older People with Dementia in Indonesia: A Feasibility Study. International Journal of Environmental Research and Public Health. 2023;20(4):3397 doi:10.3390/ijerph20043397). The exercises included warm up, balance, resistance and walking exercises, with the physiotherapist aiming for moderate-intensity exercise level, in terms of exercise demands and difficulty for each participant (e.g., by changing the repetitions, load, and foot position). Judgement of the level of challenge of the exercises relative to the participant’s ability will based on observation and questioning of the participant by the physiotherapist. As the exercise program has a multimodal focus (including balance exercises), use of a single domain tool such as the Borg RPE scale would not be able to be utilised across the variety of exercises used. The physiotherapist will select the appropriate exercises which will be tailored to address mobility, balance, and other physical problems identified from the assessments. A training manual and a training session will be provided by the researcher (YMS) to physiotherapists delivering the intervention. Participants with dementia will undertake the exercise program for 12 weeks, 5 sessions per week and 60 minutes per session and will receive two home visits (face to face) at participant’s home at weeks 1 and 6 and two online visits using zoom from the physiotherapist at weeks 3 and 10 during the 12-week intervention duration. Before the online visits, participating dyads (dyads of participants with dementia and carers) will attend an online orientation session led by the physiotherapist. The physiotherapist will explain and demonstrate the zoom software, testing the camera sound for performing the exercise program, setting the device distance and environment for performing the exercises and will explain about safe performance when undertaking the exercises. During the visits, the physiotherapist who will deliver the exercise program will monitor and tailor/modify the program where required and answer any questions in each visit. An exercise information booklet that is specifically designed for this study that explains the exercises in plain language will be provided to each participant or carer by the physiotherapist to give instructions and illustrations for the participant to undertake the exercise program independently. A set of ankle weights will also be provided to participants for undertaking strength exercises. The physiotherapist will contact participants or the carers at weeks 2, 5, 8 and 11 in between visits by telephone (four check-up phone calls during the exercise intervention period) to motivate participation with the exercise program, to inquire if they have experienced any negative effects or adverse events during the intervention and answer any questions about the exercise program. An online session via zoom about additional background information about dementia and support in caring for an older person with dementia will be provided by an Alzheimer’s Indonesia volunteer between the exercise and follow-up sessions. An exercise diary will be used to monitor adherence to the program (i.e., collecting data on times/week, type of exercise, sets, repetition and load (kgs) of exercises undertaken) by participants with the assistance of their carer. At the end of the 12-week program, a re-assessment of physical function by the physiotherapist assessor and a survey to explore the experience of participants with dementia, their carers and physiotherapist in this program will be conducted, and participants and their carers will be asked to continue the program on their own for an additional 6 weeks without physiotherapist visits or supervision. A follow up assessment by the physiotherapist assessor (different to the physiotherapist delivering the exercise intervention) and a survey to participants with dementia and their carers will be conducted 6 weeks after exercise program completion (18 weeks after baseline assessment) to provide preliminary data on the sustainability of exercise participation beyond the period with physiotherapist oversight.
Intervention code [1] 326754 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335726 0
Feasibility - Demand; using researcher's note
Demand assessed as a composite of the number of participants who (1) enquired about the program, (2) were recruited into the program, and (3) completed the 12- and 18-week program, and will be recorded by the researcher.
Timepoint [1] 335726 0
Demand will be recorded at study completion.
Primary outcome [2] 335738 0
Feasibility - implementation
Implementation assessed as a composite of (a) exercise adherence rate and (b) drop out rate. Exercise adherence rate will be calculated as the percentage of recommended exercise sessions completed, and will be recorded using an exercise diary. The drop out rate will be recorded by the researcher when any of the participants withdraw from the study. Reasons for withdrawal will also be collected.
Timepoint [2] 335738 0
An exercise diary to record the exercise undertaken will be completed by participants each day they exercise, and they will return the diaries to the researcher at the end of each month of the 18 weeks study.
Drop out rate will be recorded at study completion
Primary outcome [3] 335739 0
Feasibility - practicality (including safety)
Assessed as the composite of practicality and safety of the program. Practicality refers to whether participants were able to perform the exercise program (combination of face-face and telehealth-delivered exercises) supervised by the intervention physiotherapist and also with supervision of the carer in between physiotherapy contacts. Data of practicality will be recorded by the researcher. In addition, safety of the program defined as the frequency and nature of adverse events. Data on any adverse event will be collected prospectively using an adverse event and falls diary and verified during the face-to-face and online exercise sessions, and follow-up/support sessions.
Timepoint [3] 335739 0
Data on practicality including safety of the program will be collected during the data collection duration for each participant, which will include the 12 week intervention and 6 weeks post-intervention follow-up.
Secondary outcome [1] 425350 0
Primary outcome (4)
Feasibility-Adaptation; using researcher's note
describes any changes made in the exercise program to meet the needs of older people with dementia in Indonesia and to tailor the new method (combination of face-to-face and telehealth exercise delivery) and to ensure the participant’s safety. This exercise program will be individualised and tailored based on participants’ physical performance, assessment findings, and observation of participant’s initial attempts at selected exercises determined as suitable by the physiotherapist. The exercise level will be gradually progressed over time for participants as they improve their ability to complete the program’s current exercises.
Timepoint [1] 425350 0
Primary timepoint (4)
Data on adaptation will be recorded to study completion .
Secondary outcome [2] 425351 0
Secondary outcome (1)
Mobility assessed using the de Morton Mobility Index (DEMMI)
Timepoint [2] 425351 0
Secondary timepoint (1)
Measured at baseline, 12 (post-intervention) and 18 (i.e., 6 weeks post intervention) weeks
Secondary outcome [3] 425422 0
Secondary outcome (2)
Balance assessed using Balance Outcome Measure for Elder Rehabilitation (BOOMER)
Timepoint [3] 425422 0
Secondary timepoint (2)
Measured at baseline, 12 (post-intervention) and 18 (i.e., 6 weeks post intervention) weeks
Secondary outcome [4] 425423 0
Secondary outcome (3)
Endurance assessed using the Two-Minute Walking Test (2MWT)
Timepoint [4] 425423 0
Secondary timepoint (3)
Measured at baseline, 12 (post-intervention) and 18 (i.e., 6 weeks post intervention) weeks
Secondary outcome [5] 425424 0
Secondary outcome (4)
Lower limb strength assessed using the 30s sit-to-stand test
Timepoint [5] 425424 0
Secondary timepoint (4)
Measured at baseline, 12 (post-intervention) and 18 (i.e., 6 weeks post intervention) weeks
Secondary outcome [6] 426167 0
Secondary outcome (5)
Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI).
Timepoint [6] 426167 0
Secondary timepoint (5)
Measured at baseline, 12 (post-intervention) and 18 (i.e., 6 weeks post intervention) weeks
Secondary outcome [7] 426168 0
Secondary outcome (6)
Experience of participants with dementia, their carers and physiotherapist in this program.

The experience of participants with dementia and their carers participating in the program will be explored with a survey that will record their (1) enjoyment, (2) barriers and enablers in undertaking and assisting (for the carers) the exercise program with and without physiotherapist supervision, (3) factors that influence the adherence and completion of the program, and (4) suggestions to improve the program in the future.

The experience of physiotherapists delivering the exercise program will be explored with a survey that will record their (1) challenges and enablers in delivering the exercise program and (2) suggestions to improve the program in the future.
Timepoint [7] 426168 0
Secondary timepoint (6)
Participants with dementia and their carers who complete and withdraw from the program will be surveyed online after the intervention (12 weeks) and 6 weeks after completion of the intervention (18 weeks) or after the program withdrawal (for those who withdraw).

The physiotherapists will also be surveyed once they have completed delivering the intervention with all of their assigned participants.

Eligibility
Key inclusion criteria
People with dementia: (a) older people (living in Jakarta and Surakarta city, Indonesia, and aged 60+ years) (b) diagnosis of dementia (any form of dementia will be included) from a medical specialist (e.g., geriatrician, neurologist) (c) dementia severity to be mild or moderate (Montreal Cognitive Assessment (MoCA) score of 10-25), (d) being able to walk independently or with supervision (with or without a gait aid), (e) living in the community, (f) having no other major neurological history or medical conditions preventing participation in exercise, and (g) having a carer willing to be involved and assist in the program, and (h) having a computer/laptop/tablet and internet connection.

Carers may be either informal (e.g., family) or paid carers, and will be: (a) aged >18 years (both males and females), (b) available to participate in face-to-face and online exercise sessions and supervise the person with dementia to exercise in between the exercise sessions by the physiotherapist, (c) familiar with the participant’s medical conditions, (d) able to communicate with the person with dementia, physiotherapist and the researcher.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with dementia will be excluded if they have severe dementia (MoCA score of <10), have unstable medical conditions and are unable to understand instructions.

Carers will be excluded if they have physical and/or mental limitation that prevent them from participating in the program.

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)
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
A feasibility pre-post single group study design
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will be reported for all measures of participants, and for feasibility outcomes. Continuous variables will be presented as medians with interquartile ranges (IQR) or means with standard deviations (SD) depending on the normality of distribution. Intention-to-treat analysis method will be conducted in all analyses. Multiple imputation of missing data (missing at random) will be used to manage missing data due to participants dropping out during the study duration. For the efficacy testing component, to evaluate the preliminary effects of the exercise program, one-way repeated measures analysis of variance (1-way RM ANOVA) will be conducted to evaluate change across the three time points (baseline, 12 weeks, 18 weeks). The post-hoc least significant difference (LSD) test will be used to determine pairwise significance between time points. The p value for analyses will be set at <0.05.

Qualitative data from the survey will be coded using content analysis. Coded data will be sorted into categories based on how they are related, and the emergent themes will be identified by one researcher (YMS) and other researchers will verify the codes and categorisation. The frequency of data in each theme will be calculated and presented as percentages.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
23/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
6
Final
Recruitment outside Australia
Country [1] 25710 0
Indonesia
State/province [1] 25710 0
Jakarta and Surakarta

Funding & Sponsors
Funding source category [1] 314563 0
University
Name [1] 314563 0
Rehabilitation, Ageing and Independent Living (RAIL) Research Centre, Monash University, Australia
Country [1] 314563 0
Australia
Primary sponsor type
Individual
Name
Dr. Yulisna Mutia Sari
Address
ATZI CENTER Unika Atma Jaya, Gedung K2, Lt. 3, K23.14, Jl. Jenderal Sudirman 51, Jakarta 12930, Indonesia
Country
Indonesia
Secondary sponsor category [1] 316521 0
Individual
Name [1] 316521 0
Professor Keith Hill
Address [1] 316521 0
Rehabilitation, Ageing and Independent Living Research Centre, Monash Universitry
McMahons Road, Frankston, Victoria 3199
Country [1] 316521 0
Australia
Other collaborator category [1] 282791 0
Charities/Societies/Foundations
Name [1] 282791 0
Indonesian Physiotherapy Association (IPA)
Address [1] 282791 0
ATZI CENTER Unika Atma Jaya, Gedung K2, Lt. 3, K23.14, Jl. Jenderal Sudirman 51, Jakarta 12930, Indonesia
Country [1] 282791 0
Indonesia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313599 0
Human Research Ethics Committees for Health Research, University of Muhammadiyah Surakarta, Indonesia
Ethics committee address [1] 313599 0
Ethics committee country [1] 313599 0
Indonesia
Date submitted for ethics approval [1] 313599 0
15/08/2023
Approval date [1] 313599 0
23/10/2023
Ethics approval number [1] 313599 0

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

Contacts
Principal investigator
Name 128702 0
Dr Yulisna Mutia Sari
Address 128702 0
Monash University Indonesia, Green Office 9 Building, Jl. BSD Green Office Park, Sampora, Cisauk, Tangerang Regency, Banten, 15345
Country 128702 0
Indonesia
Phone 128702 0
+6282181807912
Fax 128702 0
Email 128702 0
[email protected]
Contact person for public queries
Name 128703 0
Yulisna Mutia Sari
Address 128703 0
Monash University Indonesia, Green Office 9 Building, Jl. BSD Green Office Park, Sampora, Cisauk, Tangerang Regency, Banten 15345
Country 128703 0
Indonesia
Phone 128703 0
+6282181807912
Fax 128703 0
Email 128703 0
[email protected]
Contact person for scientific queries
Name 128704 0
Yulisna Mutia Sari
Address 128704 0
Monash University Indonesia, Green Office 9 Building, Jl. BSD Green Office Park, Sampora, Cisauk, Tangerang Regency, Banten 15345
Country 128704 0
Indonesia
Phone 128704 0
+6282181807912
Fax 128704 0
Email 128704 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of de-identified individual participant data of published results only.
When will data be available (start and end dates)?
After study publication, and ending 3 years after publication of the main study findings
Available to whom?
Access to de-identified data will be made available subject to (1) request by external researchers or participating organisations (e.g., Alzheimer’s Indonesia Association); and (2) consideration of the requested purpose of use of the data by the research team.
Available for what types of analyses?
Analyses aiming to pool this data with other studies data
How or where can data be obtained?
The deidentified data can be made available on reasonable request to the corresponding author by email to [email protected].


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
No additional documents have been identified.