Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12621001686897
Ethics application status
Approved
Date submitted
31/05/2021
Date registered
9/12/2021
Date last updated
9/12/2021
Date data sharing statement initially provided
9/12/2021
Date results information initially provided
9/12/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
Piloting a multicomponent frailty management program for community-dwelling older adults in Singapore
Query!
Scientific title
Effectiveness of a multicomponent frailty management program among community-dwelling older adults in Singapore: A pilot-controlled trial
Query!
Secondary ID [1]
304365
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Frailty
322150
0
Query!
Falls
322151
0
Query!
Condition category
Condition code
Physical Medicine / Rehabilitation
319844
319844
0
0
Query!
Other physical medicine / rehabilitation
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
A non-randomised controlled trial involving a 12-week intervention, 1-month and 3-month post-intervention follow-ups were conducted at two community sites. Participants were allocated to either an experimental group (EG) or a control group (CG) at different sites according to their personal preferences without randomisation.
Participants in the experimental group underwent a multicomponent frailty management program (mFMP) facilitated by a programme leader who is an allied health professional. The program consisted of 12 weekly sessions and was conducted in a small group setting (n=10-14).
Each weekly session consisted of a 1-hour sharing session on topics relating to frailty (e.g. energy conservation technique, healthy diet, medication, chronic disease management, fall prevention and community participation) by different healthcare professionals, such as the dietician, pharmacist, physiotherapist and occupational therapist. This was followed by 15 minutes tea break and another 45 minutes of physical exercises targeting balance (e.g. sit-to-stand, tandem stand), strength (e.g. arm strengthening, leg raise, heel raise, side hip strengthening) and endurance (e.g. daily walking) conducted by the program leader.
Homework including strength and balance exercises and various content topics were assigned to participants. Weekly homework sheets including the individualized sets of exercises were given to each participant and checked by the program leader weekly. All exercises were mild intensity adapted from the Otago Exercise Program and ViviFrail.com. Participants were recommended to do the strength exercises 3-4 times per week and balance exercises daily. The exercise specialist and program facilitator will upgrade the intensity level when individual participants progress during the 12-week intervention.
Individual goals were explored and discussed at the start of the program and reviewed upon completion of the program by the program leader.
A 2-hour booster session was conducted to recap the program contents (including exercises) at 1-month post-intervention. During the booster session, participants shared their goal achievements, their strategy implementation and challenges. Professional advice and relevant community resources were provided to the participants by the program leader.
A 20-minute phone call follow-up was conducted at 3-month post-intervention. Similar to the booster session, participants shared their goal achievements, strategy implementation and challenges and future plans.
As part of the feasibility study, participants’ weekly attendance will be recorded and homework were checked by the program leader to assess their compliances.
Query!
Intervention code [1]
320725
0
Rehabilitation
Query!
Intervention code [2]
320726
0
Lifestyle
Query!
Intervention code [3]
320727
0
Behaviour
Query!
Comparator / control treatment
Participants in the control group underwent a 12-week standard fitness program facilitated by a qualified fitness instructor in a small group setting (n=10-14). It consisted of weekly 1-hour social bonding and sharing sessions, followed by 45 minutes of physical exercise targeting balance, strength and endurance conducted by the fitness instructor.
During the social bonding and sharing session, participants were instructed to socialise with no structured topic facilitated by the fitness instructor. Some topics introduced during the sharing sessions included general health tips, the importance of exercises, self pain management, stress management.
During the exercise sessions, participants firstly learned balance and strength exercises (e.g. chair raise, half squats, leg raise, single leg stand, tandem walking) with low intensity and progressed to moderate intensity (e.g. cardio walk with music, Zumba and body pump), towards the end of the 12-week intervention. No homework exercises were prescribed to all participants in the control group between each weekly session.
A 30-minute phone call follow-up was conducted 1-month post-intervention. Participants were asked to share their goal achievements and challenges.
Participants were reassessed using the selected outcome measures during a 45-minute phone call at 3-month post-intervention.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
327712
0
The Clinical Frailty Scale was used to assess the level of frailty.
Query!
Assessment method [1]
327712
0
Query!
Timepoint [1]
327712
0
This was conducted at the baseline, immediately post-intervention (primary endpoint) and 3 months post-intervention.
Query!
Secondary outcome [1]
396312
0
A 16-item Falls Efficacy Scale-International (FES-I) was used to assess the fear of falling.
Query!
Assessment method [1]
396312
0
Query!
Timepoint [1]
396312
0
This was conducted at the baseline, immediately and 3 months post-intervention.
Query!
Secondary outcome [2]
396313
0
Fatigue Severity Scale (FSS) was used to assess the fatigue levels and the impact on Activities of Daily Living.
Query!
Assessment method [2]
396313
0
Query!
Timepoint [2]
396313
0
This was conducted at the baseline, immediately and 3 months post-intervention.
Query!
Secondary outcome [3]
396314
0
Modified Barthel Index (MBI) was used to screen the level of independence in Activities of Daily Living.
Query!
Assessment method [3]
396314
0
Query!
Timepoint [3]
396314
0
This was conducted at the baseline, immediately and 3 months post-intervention.
Query!
Secondary outcome [4]
396315
0
Jamar Hand Dynamometer was used to test the handgrip strength.
Query!
Assessment method [4]
396315
0
Query!
Timepoint [4]
396315
0
This was conducted at the baseline and immediately post-intervention.
Query!
Secondary outcome [5]
396316
0
Fall data were collected using the provided data collection sheet by the program leaders at each contact point (e.g. weekly sessions) and phone call follow-ups.
Query!
Assessment method [5]
396316
0
Query!
Timepoint [5]
396316
0
were recorded from baseline to 3 months post-intervention completion.
Query!
Eligibility
Key inclusion criteria
Inclusion criteria
- Aged 65 and above
- Able to ambulate independently with or without a walking aid
- Living at home
- Clinical Frailty Scale scored between 4-6
Query!
Minimum age
65
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- cognitive impairment with Abbreviated Mental Test (AMT) scores < 6;
- major depression or other psychological disorders;
- severe audio-visual impairment;
- existing major mobility limitation with Short Performance Physical Battery scores < 3 or unable to complete 4-metre walk test component;
- unable to understand English or Mandarin;
having a terminal illness with a life expectancy < 12 months.
Query!
Study design
Purpose of the study
Educational / counselling / training
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Analysis of variance and the chi-square test was used to analyze differences in baseline characteristics and baseline outcome measures in both groups. To determine the intervention effect for both groups at three-time points (baseline, post-intervention, and follow-up), mixed ANOVA was performed. Tukey's post hoc test was carried out if a group × time interaction is observed. A statistically significant level will be set at 0.05 for all comparisons. Besides the p-values, the effect size (partial eta squared) was calculated to determine group differences for each outcome measure. The effect size greater than 0.138 is considered to be a large effect; between 0.138 and 0.059 is a moderate effect, and between 0.01 and 0.059 is a small effect (Cohen, 1988). All data analysis was performed with SPSS for Windows, version 25 software (SPSS Inc., Chicago, IL).
Data gathered from interviews and weekly field notes from the program leaders were thematically analysed to identify recurrent themes.
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
21/03/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
30/04/2019
Query!
Date of last data collection
Anticipated
Query!
Actual
1/11/2019
Query!
Sample size
Target
28
Query!
Accrual to date
Query!
Final
23
Query!
Recruitment outside Australia
Country [1]
23741
0
Singapore
Query!
State/province [1]
23741
0
Query!
Funding & Sponsors
Funding source category [1]
308737
0
University
Query!
Name [1]
308737
0
Singapore Institute of Technology
Query!
Address [1]
308737
0
10 Dover Drive,
Singapore 138683
Query!
Country [1]
308737
0
Singapore
Query!
Primary sponsor type
University
Query!
Name
Singapore Institute of Technology
Query!
Address
10 Dover Drive,
Singapore 138683
Query!
Country
Singapore
Query!
Secondary sponsor category [1]
309633
0
None
Query!
Name [1]
309633
0
Query!
Address [1]
309633
0
Query!
Country [1]
309633
0
Query!
Other collaborator category [1]
281815
0
Other
Query!
Name [1]
281815
0
Wellness Kampung@Yishun 115
Query!
Address [1]
281815
0
Blk 115 #01-495, Yishun Ring Rd, Singapore 760115
Query!
Country [1]
281815
0
Singapore
Query!
Other collaborator category [2]
281816
0
Other
Query!
Name [2]
281816
0
The Church of Our Lady Star of the Sea
Query!
Address [2]
281816
0
10 Yishun Street 22, Singapore 768579
Query!
Country [2]
281816
0
Singapore
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
308658
0
The Institutional Review Board of Singapore Institute of Technology
Query!
Ethics committee address [1]
308658
0
Singapore Institute of Technology
10 Dover Drive
Singapore 138683
Query!
Ethics committee country [1]
308658
0
Singapore
Query!
Date submitted for ethics approval [1]
308658
0
07/02/2019
Query!
Approval date [1]
308658
0
20/03/2019
Query!
Ethics approval number [1]
308658
0
2019014
Query!
Summary
Brief summary
With the increasing ageing population worldwide, the prevalence of frailty is likely to rise. In Singapore, the prevalence of pre-frailty and frailty among local community-dwelling older adults were 37% and 6.2% respectively. Several studies have identified the effectiveness of a multicomponent frailty management program, but limited studies were done in Singapore.
This study aimed to determine the feasibility and effectiveness of a multicomponent frailty management program (mFMP) in reducing frailty status among community-frail older adults in Singapore.
A non-randomised controlled trial was conducted. Sixteen out of 23 participants completed the 12-week programs. Pre-post assessments were conducted to compare the differences in physical and psychological functions between the mFMP (Experimental Group) and a fitness program (Control Group) in 12-week and 3-month follow-up. The primary outcome measure was the Clinical Frailty Scale score.
It was hypothesized that the multicomponent program was more effective in reducing frailty and its adverse consequences. Results of the study would provide insights on the feasibility and effectiveness of such a program which may be implemented in Singapore for older people at risk of frailty.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
111450
0
Dr Tianma Xu
Query!
Address
111450
0
Health and Social Sciences Cluster
Singapore Institute of Technology
10 Dover Drive
Singapore 138683
Query!
Country
111450
0
Singapore
Query!
Phone
111450
0
+65 65928673
Query!
Fax
111450
0
Query!
Email
111450
0
[email protected]
Query!
Contact person for public queries
Name
111451
0
Dr Tianma Xu
Query!
Address
111451
0
Health and Social Sciences Cluster
Singapore Institute of Technology
10 Dover Drive
Singapore 138683
Query!
Country
111451
0
Singapore
Query!
Phone
111451
0
+65 65928673
Query!
Fax
111451
0
Query!
Email
111451
0
[email protected]
Query!
Contact person for scientific queries
Name
111452
0
Dr Tianma Xu
Query!
Address
111452
0
Health and Social Sciences Cluster
Singapore Institute of Technology
10 Dover Drive
Singapore 138683
Query!
Country
111452
0
Singapore
Query!
Phone
111452
0
+65 65928673
Query!
Fax
111452
0
Query!
Email
111452
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
In view of our organizational data management policy and personal data protection act by law in Singapore, we are unable to share individual participant data.
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
11864
Ethical approval
382098-(Uploaded-31-05-2021-18-00-03)-Study-related document.pdf
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.
Download to PDF