Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001620819
Ethics application status
Approved
Date submitted
9/05/2021
Date registered
26/11/2021
Date last updated
21/09/2023
Date data sharing statement initially provided
26/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility and effectiveness of an online,group-based exercise program on fall, muscle strength and quality of life among older adults.
Scientific title
Feasibility and effectiveness of a six months period of virtual exercise program via zoom apps delivery method on the risk of fall, muscle strength, balance and quality of life among community-dwelling older adults aged 60 years and above from Kuching, Sarawak.
Secondary ID [1] 304148 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Risk of falls measure by Time Up and Go test. 321864 0
Condition category
Condition code
Physical Medicine / Rehabilitation 319589 319589 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial consisted of 2 phases, phase 1 will be the development of a virtual falls prevention exercise program and acceptability among community-dwelling older adults. Phase 2 will be the implementation and evaluation of the virtual exercise program after refining it based on the input from phase 1 with the records of the adherence rate of the exercise program. In phase 1, one virtual focus group discussion will be carried out after one session of the virtual exercise program to explore older adults perception towards the exercise program design. After, completed phase 1 virtual focus group discussion, the input and feedback from phase 1 will be collected and the exercise program design will adjust accordingly before proceeding to phase 2. In phase 2, one virtual fall prevention education session will be conducted and a virtual supervise group-based exercise program were conducted twice per week with 75 minutes in each session via Zoom.us. apps. The same participants will be involved in phase 1 as in phase 2. The virtual supervise group-based falls prevention exercise program in six-month duration. The exercise design develops based on current evidence and aimed to examine the effects on the risk of falls, balance, muscle strength and quality of life among community-dwelling older adults. The education session will be provided for both group participants in different sessions. The fall prevention education session will be delivered by a physiotherapist one session for 6 months and interactive activities such as questions and answer sessions before the virtual supervise exercise program starts. The education sessions included the prevalence of falls in Malaysia, fall risks factors, type of exercise benefit to prevent falls among community-dwelling older adults. The attendance at the virtual fall prevention education session will be recorded. After attending the fall prevention education session virtually, intervention group participants will continue with the supervising group-based exercise. The virtual exercise is a multicomponent exercise that contains a warm-up session with aerobics and music, strengthening exercises for upper and lower limbs, static and dynamic balance training, stepping mat exercises, backwards chaining floor exercise training and a cool-down session with flexibility exercise with 3 different levels of intensity measure by Borg Rating of perceived exertion (RPE) scale. Level 1 (first two months) indicates the low-intensity light (9-12) Borg RPE, level 2 the moderate intensity (11-15) Borg RPE and level 3 will be high intensity (14-17) Borg RPE. The virtual exercise will be conducted with a maximum of 7 persons a session, supervised by a physiotherapist. The adherence rate will be recorded based on the attendance checklist.
Intervention code [1] 320500 0
Rehabilitation
Intervention code [2] 320501 0
Prevention
Comparator / control treatment
A fall prevention education session which same with the intervention group and continues usual daily activities.
Control group
Active

Outcomes
Primary outcome [1] 327452 0
1) Risk of falls as assessed by Timed Up- And-Go test
Timepoint [1] 327452 0
Baseline and post-intervention (6 months later)
Primary outcome [2] 328498 0
2) Balance as assessed by Single Leg Stance test
Timepoint [2] 328498 0
Baseline and post-interventions ( 6 months later)
Primary outcome [3] 328499 0
3) Upper limb muscle strength- Upper limb as assessed by hand dynamometer
Timepoint [3] 328499 0
Baseline and post-intervention (6 months later)
Secondary outcome [1] 395162 0
Quality of life as assessed by EQ-5D-3L self admit questionnaire.
Timepoint [1] 395162 0
Baseline and post-intervention (6 months later)
Secondary outcome [2] 399202 0
Fall Efficacy Scale as assessed by Short FES-I.
Timepoint [2] 399202 0
Baseline and post-intervention (6 months later)
Secondary outcome [3] 399203 0
The number of falls as assessed by self-reported fall diaries.
Timepoint [3] 399203 0
Monthly report
Secondary outcome [4] 403000 0
Lower limb muscle strength as assessed by five times sit to stand test. This is the primary outcome.
Timepoint [4] 403000 0
Baseline and post-intervention (6 months later)

Eligibility
Key inclusion criteria
• aged > 60 years and above from the local community
• able to ambulate independently with or without a walking stick
• those who have a falls risk.
• those who have smartphone or device to connect to the internet.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• participants with acute or chronic conditions who are unable to complete an hour exercise program which includes severe musculoskeletal pain, cardiovascular diseases such as stroke with hemiplegia and unstable angina.
• neurological diseases with progressive weakness.
• postural hypotension, vestibular problem.
• uncorrected visual issues.
• cognitive deficits (Montreal Cognitive Assessment (MoCA) test score less than 20).
• participating in another exercise program six weeks ago.
• unable to read and understand Bahasa Malaysia or 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)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
52 total participants and 26 participants per group will be considered adequate for this study.NVIvo software and Statistical Package for Social Science Version 25 was used to analyse data. The acceptability of the virtual supervised community-based group exercise program will be analysed using thematic analysis. The effects of the virtual supervised exercise program will be analysed using mix-designed ANOVA and independent t-test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/04/2021
Date of last participant enrolment
Anticipated
Actual
15/11/2021
Date of last data collection
Anticipated
25/02/2022
Actual
29/04/2022
Sample size
Target
52
Accrual to date
Final
52
Recruitment outside Australia
Country [1] 23684 0
Malaysia
State/province [1] 23684 0
Sarawak

Funding & Sponsors
Funding source category [1] 308523 0
Self funded/Unfunded
Name [1] 308523 0
Janet Bong May Ing
Country [1] 308523 0
Malaysia
Primary sponsor type
Individual
Name
Janet Bong May Ing
Address
NO 568, Lorong 1
Batu 22, Tapah
Jalan Kuching-Serian
94200 Serian Sarawak
Country
Malaysia
Secondary sponsor category [1] 309379 0
None
Name [1] 309379 0
Address [1] 309379 0
Country [1] 309379 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308479 0
Ethics Committee of The National University of Malaysia
Ethics committee address [1] 308479 0
Ethics committee country [1] 308479 0
Malaysia
Date submitted for ethics approval [1] 308479 0
15/04/2021
Approval date [1] 308479 0
19/04/2021
Ethics approval number [1] 308479 0
JEP-2020-611
Ethics committee name [2] 309158 0
Medical Research & Ethics Committee Ministry of Health Malaysia
Ethics committee address [2] 309158 0
Ethics committee country [2] 309158 0
Malaysia
Date submitted for ethics approval [2] 309158 0
03/04/2021
Approval date [2] 309158 0
09/06/2021
Ethics approval number [2] 309158 0
NMRR-20-2289-56760

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

Contacts
Principal investigator
Name 110838 0
A/Prof Devinder Kaur A/P Ajit Singh
Address 110838 0
Centre for Healthy Ageing and Wellness
Physiotherapy Program
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Malaysia
Country 110838 0
Malaysia
Phone 110838 0
+60392897352
Fax 110838 0
+60392897163
Email 110838 0
[email protected]
Contact person for public queries
Name 110839 0
Devinder Kaur A/P Ajit Singh
Address 110839 0
Physiotherapy Program
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Malaysia
Country 110839 0
Malaysia
Phone 110839 0
+60392897352
Fax 110839 0
+60392897163
Email 110839 0
[email protected]
Contact person for scientific queries
Name 110840 0
Devinder Kaur A/P Ajit Singh
Address 110840 0
Physiotherapy Program
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Malaysia
Country 110840 0
Malaysia
Phone 110840 0
+60392897352
Fax 110840 0
+60392897163
Email 110840 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?
Individual participant data underlying published results
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12408Informed consent form  [email protected]
12409Study protocol  [email protected]
12410Statistical analysis plan  [email protected]
12411Ethical approval  [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.