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Trial registered on ANZCTR


Registration number
ACTRN12619001055190
Ethics application status
Approved
Date submitted
11/06/2019
Date registered
29/07/2019
Date last updated
29/07/2019
Date data sharing statement initially provided
29/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Integrated physical and cognitive training intervention to reverse cognitive frailty among community dwelling older adults
Scientific title
Integrated physical and cognitive training intervention to reverse cognitive frailty among community dwelling older adults
Secondary ID [1] 297877 0
nil known
Universal Trial Number (UTN)
Trial acronym
WE- RISE

Warga Emas (WE) - translation of Senior Citizens in the Malay Language

Robust mInd and muScle Exercise (RISE)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognitive frailty 312386 0
frailty 312387 0
cognitive impairment 312388 0
Condition category
Condition code
Physical Medicine / Rehabilitation 310941 310941 0 0
Physiotherapy
Neurological 311752 311752 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BRIEF NAME: WE RISE Project - Warga Emas Robust mInd and muscle Exercise Program.
(Warga Emas means older adults in the Malay Language)
WHY:
The co-existence of both frailty and cognitive impairment has been termed as ‘Cognitive frailty’ and has been identified as one of the main precursors to dementia. In a recent study in Singapore, older adults with pre-frailty and frailty coupled with cognitive impairment were found to be at a higher risk of having functional disability, poor quality of life and increased mortality. This study will the first of its kind to provide a modality which could potentially reverse cognitive frailty, as compared to the ‘usual care’ management practice for older adults. There is a need to develop and implement an intervention package which is cost- effective, integrated and applies interdisciplinary approaches for successful outcomes. This intervention can be packaged and delivered by interdisciplinary trainers to be implemented in health care service provider centers. Not only will this intervention package optimize the cost of geriatric healthcare, it is also sustainable, and it aims to enrich the lives of the ageing population.
WHAT:
This is a intervention study which mainly focuses on the domains of physical exercise and cognitive stimulation with the aim of potentially reversing cognitive frailty among community dwelling older adults.
Group 1: Intervention Group
Intervention group will be receiving 12 weeks of exercise-based programme in combination with cognitive stimulation training. Materials used during intervention include weight-cuffs, chairs, basketballs, cognitive stimulating games and stationary.
The exercises included in this study were effective evidence based exercises for older adult from systematic reviews.
The intervention session comprise of the following:
1. Warm up & Dynamic Stretching – 10 minutes
2. Dance Aerobics – 15 minutes
3. Progressive resistance training – 20 minutes
- weight cuffs were used for progressive resistance training in addition to body weight exercises.
- 1st to 4th week = 0.5kg
- 5th to 8th week = 1.0kg
- 9th to 12th week = 2.0kg
Repetitions were increased from 8 to 10 repetitions/ 3 sets per session.
4. Balance & Coordination Training – 20 minutes
Level 1
• Weight shifting
• Single leg stand
• Semi tandem stand
• Tandem stand
• Side walking
• Frontward/backward walking
• Passing ball around in a circle
• Ball dribbling/catching
• Single direction ball throwing (partner activity)
• Hand-eye coordination training


Level 2
• Weight shifting
• Single leg stand without support
• Semi tandem stand
• Tandem stand & walk
• Side walking with a turn
• Frontward/backward walking with a turn
• Heel & tiptoe walk
• Ball throwing/catching in different directions in a circle
• Slalom walking with a ball
• Messy walking around obstacles
• Dribbling/catching with one hand
• Hand-eye coordination training

Level 3
• Weight Shifting
• Single leg stand eyes open/eyes closed
• Semi tandem stand
• Tandem stand
• Tandem walk with ball
• Dribble/throw upwards ball and catch
• Side walking with a turn with ball
• Heel & tiptoe walk with a turn with ball
• Frontward/backward walking with a turn with ball
• Throwing & catching ball in different directions while rotating in circle
• Messy walking while picking up objects
• Slalom walking while carrying a tray of cups
• Hand-eye coordination training

5. Cognitive Stimulation Activities – 20 minutes

Cognitive stimulation will include the following:
-Jigsaw Puzzle - Visuospatial Reasoning & Working memory
-Sorting Games - Executive Function & Cognitive Flexibility
-Spot the difference - Attention & Processing Speed
-Maze games - Problem Solving Skills
-Recall Activity - Short Term Memory
-Memory Card Games - Reaction Time,Attention,Processing Speed
-Colouring Games - Concentration & Matrix Reasoning





Group 2: Control Group (Active)
Receiving usual care as provided by the older adult activity centers.
WHO PROVIDED:
Physiotherapist with post graduate qualification in community based geriatric health.
HOW:
Intervention was executed in the form of face to face group sessions.
WHERE: In selected Older Adult Activity Centres within the states of Kuala Lumpur and Selangor in Peninsular Malaysia. Selection of centres were made based on the density of registered members at the activity centres. These centres have hall spaces which are used for the intervention.
WHEN AND HOW MUCH:
This intervention will be carried out across the span of 6 months.
First 3 months (week 1 to 12) will be the intervention phase and the last 3 months (week 13 to 24) will be the self-administered health empowerment
Intervention consists of 2 sessions per week for a period of 90 minutes per session. (total 24 sessions in 12 weeks).
Frequency: 2 sessions/week
Intensity: 65 to 80% of maximum heart rate.
Time: 85 to 90 minutes
Type: Combination of Aerobic, resistance and balance training.
TAILORING
This was a group targeted program, not tailored to the individual.
No specific adherence strategies applied, however attendance will be monitored for every session conducted. Motivation and enjoyment are also part of promoting adherence to the intervention program.
Intervention code [1] 314567 0
Rehabilitation
Intervention code [2] 314568 0
Prevention
Intervention code [3] 314569 0
Treatment: Other
Comparator / control treatment
Active Control Group - Receiving usual care from older adult activity center.

Usual care in this study is the regular participation in activities and health related services provided at the Senior Citizen centers namely handicraft activities, routine monthly health check ups and group physiotherapy sessions which are held once every two months.
Control group
Active

Outcomes
Primary outcome [1] 320182 0
Clinical Dementia Rating Scale Score
Timepoint [1] 320182 0
Baseline, at 12 weeks (at the end of intervention) and at 24 weeks (post intervention)
Primary outcome [2] 320183 0
Fried's Frailty Criteria
Timepoint [2] 320183 0
Baseline, at 12 weeks (at the end of intervention) and at 24 weeks (post intervention)
Secondary outcome [1] 370786 0
Mini Mental State Examination
Timepoint [1] 370786 0
Baseline, at 12 weeks (at the end of intervention) and at 24 weeks (post intervention)
Secondary outcome [2] 370787 0
Rey Auditory Verbal Learning Test
Timepoint [2] 370787 0
Baseline, at 12 weeks (at the end of intervention) and at 24 weeks (post intervention)
Secondary outcome [3] 370788 0
Digit Span Test
Timepoint [3] 370788 0
Baseline, at 12 weeks (at the end of intervention) and at 24 weeks (post intervention)
Secondary outcome [4] 370789 0
15-D Quality of LIfe Questionnaire
Timepoint [4] 370789 0
Baseline, at 12 weeks (at the end of intervention) and at 24 weeks (post intervention)
Secondary outcome [5] 370790 0
Senior Fitness Test
Timepoint [5] 370790 0
Baseline, at 12 weeks (at the end of intervention) and at 24 weeks (post intervention)
Secondary outcome [6] 370791 0
Diet History Questionnaire (DHQ)
Timepoint [6] 370791 0
Baseline, at 12 weeks (at the end of intervention) and at 24 weeks (post intervention)
Secondary outcome [7] 370792 0
WHO DIsability Assesment Schedule (WHODAS)
Timepoint [7] 370792 0
Baseline, at 12 weeks (at the end of intervention) and at 24 weeks (post intervention)
Secondary outcome [8] 370793 0
Physical Activiry Scale for the Elderly (PASE)
Timepoint [8] 370793 0
Baseline, at 12 weeks (at the end of intervention) and at 24 weeks (post intervention)

Eligibility
Key inclusion criteria
• Malaysian older adults aged 60 years and above.
• Community dwelling
• Independent ambulation
• Currently seeking geriatric health care services at Pusat Aktiviti Warga Emas within Klang Valley
• Identified as Pre-Frail or Frail (1 or more characteristics of frailty present based on Fried et al. 2001)
• Identified as mild cognitive impairment or very mild dementia (Score 0.5 on the Clinical Dementia Rating Scale)
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Identified as robust (0 for ‘robust’ in terms of characteristic of frailty based on Fried et al. 2001)
• Intact cognition or mild to severe dementia (0 for intact, 1-3 for mild to severe dementia on the Clinical Dementia Rating Scale)
• Major depression (Geriatric Depression Score >11)
• Diagnosed with progressive degenerative neurologic disease
• Diagnosed with terminal illness
• Participating in other interventional studies
• Unable to commit to participate throughout duration of study

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)
Simple randomisation using a randomisation table created by computer software
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
Results of the randomized controlled trial will be analyzed using repeated measures analysis of variance for pre-test (Baseline Scores) and post-test (3rd month, 6th month and 9th month follow up) for experimental and active control group. Post-hoc analysis will be conducted using Benferonni correction. Analysis will include nutritional assessment, cognitive frailty outcome measures, cognitive assessments, physical function assessments and quality of life.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21526 0
Malaysia
State/province [1] 21526 0
WP Kuala Lumpur
Country [2] 21527 0
Malaysia
State/province [2] 21527 0
selangor

Funding & Sponsors
Funding source category [1] 302402 0
University
Name [1] 302402 0
University Kebangsaan Malaysia
Address [1] 302402 0
Universiti Kebangsaan Malaysia, 43600 UKM, Bangi Selangor, MALAYSIA.
Country [1] 302402 0
Malaysia
Primary sponsor type
University
Name
University Kebangsaan Malaysia
Address
Universiti Kebangsaan Malaysia, 43600 UKM, Bangi Selangor, MALAYSIA.
Country
Malaysia
Secondary sponsor category [1] 302822 0
None
Name [1] 302822 0
Address [1] 302822 0
Country [1] 302822 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303071 0
COMMITTEE OF RESEARCH ETHICS OF NATIONAL UNIVERSITY OF MALAYSIA
Ethics committee address [1] 303071 0
SEKRETARIAT ETIKA PENYELIDIKAN UNIVERSITI KEBANGSAAN MALAYSIA
Aras 1, Blok Klinikal, Hospital Canselor TUnku Mukhriz, Pusat Perubatan UKM
Jalan Yaacob Latif, Bandar Tun Razak,
56000 Cheras, Kuala Lumpur.
Ethics committee country [1] 303071 0
Malaysia
Date submitted for ethics approval [1] 303071 0
19/07/2018
Approval date [1] 303071 0
27/09/2018
Ethics approval number [1] 303071 0
UKM PPI/111/8/JEP-2018-558

Summary
Brief summary
Frailty has been associated with falls, functional disability, hospitalisation and mortality. Ultimately, this leads to limitation in carrying out daily tasks and poor quality of life among frail older adults. Ageing healthcare service providers have proposed for more research information in decelerating cognitive frailty as a strategy to prevent negative consequences and dementia among older adults. Hence, this research main objective is to develop and evaluate the efficacy of the integrated intervention package in reversing cognitive frailty among older adults in Malaysia.

You will be interviewed to obtain sociodemographic, health status, dietary intake and lifestyle related information. Your anthropometric measurement (weight, height, body composition, waist and hip circumference), blood pressure, level of cognition, vision and auditory levels, and fitness test (upper and lower body strength, mobility and balance) will also be measured.
Should you meet the selection criteria of this study, you will be invited to participate in the 2nd part of this study over a span of 3 months. You will be randomly assigned either group 1 or group 2. Group 1 will receive the integrated intervention which will be conducted twice a week for 3 months. Group 2 will continue receiving usual care as provided by the Pusat Aktiviti Warga Emas (PAWE).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92366 0
A/Prof Devinder Kaur Ajit Singh
Address 92366 0
Centre for Healthy Aging and Wellness
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Malaysia
Country 92366 0
Malaysia
Phone 92366 0
+60392897352
Fax 92366 0
Email 92366 0
devinder@ukm.edu.my
Contact person for public queries
Name 92367 0
A/Prof Devinder Kaur Ajit Singh
Address 92367 0
Centre for Healthy Aging and Wellness
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Malaysia
Country 92367 0
Malaysia
Phone 92367 0
+60392897352
Fax 92367 0
Email 92367 0
devinder@ukm.edu.my
Contact person for scientific queries
Name 92368 0
A/Prof Devinder Kaur Ajit Singh
Address 92368 0
Centre for Healthy Aging and Wellness
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Malaysia
Country 92368 0
Malaysia
Phone 92368 0
+60392897352
Fax 92368 0
Email 92368 0
devinder@ukm.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Yet to be decided
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 3178 0
Ethical approval
Citation [1] 3178 0
Link [1] 3178 0
Email [1] 3178 0
Other [1] 3178 0
Summary results
No Results