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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 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
Scientific title
Effectiveness of a multicomponent frailty management program among community-dwelling older adults in Singapore: A pilot-controlled trial
Secondary ID [1] 304365 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 322150 0
Falls 322151 0
Condition category
Condition code
Physical Medicine / Rehabilitation 319844 319844 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 320725 0
Rehabilitation
Intervention code [2] 320726 0
Lifestyle
Intervention code [3] 320727 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 327712 0
The Clinical Frailty Scale was used to assess the level of frailty.
Timepoint [1] 327712 0
This was conducted at the baseline, immediately post-intervention (primary endpoint) and 3 months post-intervention.
Secondary outcome [1] 396312 0
A 16-item Falls Efficacy Scale-International (FES-I) was used to assess the fear of falling.
Timepoint [1] 396312 0
This was conducted at the baseline, immediately and 3 months post-intervention.
Secondary outcome [2] 396313 0
Fatigue Severity Scale (FSS) was used to assess the fatigue levels and the impact on Activities of Daily Living.
Timepoint [2] 396313 0
This was conducted at the baseline, immediately and 3 months post-intervention.
Secondary outcome [3] 396314 0
Modified Barthel Index (MBI) was used to screen the level of independence in Activities of Daily Living.
Timepoint [3] 396314 0
This was conducted at the baseline, immediately and 3 months post-intervention.
Secondary outcome [4] 396315 0
Jamar Hand Dynamometer was used to test the handgrip strength.
Timepoint [4] 396315 0
This was conducted at the baseline and immediately post-intervention.
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.
Timepoint [5] 396316 0
were recorded from baseline to 3 months post-intervention completion.

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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Educational / counselling / training
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
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/03/2019
Date of last participant enrolment
Anticipated
Actual
30/04/2019
Date of last data collection
Anticipated
Actual
1/11/2019
Sample size
Target
28
Accrual to date
Final
23
Recruitment outside Australia
Country [1] 23741 0
Singapore
State/province [1] 23741 0

Funding & Sponsors
Funding source category [1] 308737 0
University
Name [1] 308737 0
Singapore Institute of Technology
Country [1] 308737 0
Singapore
Primary sponsor type
University
Name
Singapore Institute of Technology
Address
10 Dover Drive,
Singapore 138683
Country
Singapore
Secondary sponsor category [1] 309633 0
None
Name [1] 309633 0
Address [1] 309633 0
Country [1] 309633 0
Other collaborator category [1] 281815 0
Other
Name [1] 281815 0
Wellness Kampung@Yishun 115
Address [1] 281815 0
Blk 115 #01-495, Yishun Ring Rd, Singapore 760115
Country [1] 281815 0
Singapore
Other collaborator category [2] 281816 0
Other
Name [2] 281816 0
The Church of Our Lady Star of the Sea
Address [2] 281816 0
10 Yishun Street 22, Singapore 768579
Country [2] 281816 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308658 0
The Institutional Review Board of Singapore Institute of Technology
Ethics committee address [1] 308658 0
Ethics committee country [1] 308658 0
Singapore
Date submitted for ethics approval [1] 308658 0
07/02/2019
Approval date [1] 308658 0
20/03/2019
Ethics approval number [1] 308658 0
2019014

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

Contacts
Principal investigator
Name 111450 0
Dr Tianma Xu
Address 111450 0
Health and Social Sciences Cluster
Singapore Institute of Technology
10 Dover Drive
Singapore 138683
Country 111450 0
Singapore
Phone 111450 0
+65 65928673
Fax 111450 0
Email 111450 0
tim.xu@singaporetech.edu.sg
Contact person for public queries
Name 111451 0
Tianma Xu
Address 111451 0
Health and Social Sciences Cluster
Singapore Institute of Technology
10 Dover Drive
Singapore 138683
Country 111451 0
Singapore
Phone 111451 0
+65 65928673
Fax 111451 0
Email 111451 0
tim.xu@singaporetech.edu.sg
Contact person for scientific queries
Name 111452 0
Tianma Xu
Address 111452 0
Health and Social Sciences Cluster
Singapore Institute of Technology
10 Dover Drive
Singapore 138683
Country 111452 0
Singapore
Phone 111452 0
+65 65928673
Fax 111452 0
Email 111452 0
tim.xu@singaporetech.edu.sg

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11864Ethical 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.