FrailtyEPPICNCT06418425
Exercise Program and Protein Intake Counselling for Frailty Prevention in Singapore
A study testing counselling on home-based exercise program and dietary protein intake in people with Frailty, run by National Healthcare Group Polyclinics at 1 site in Singapore.
Trial summary
This is a randomized controlled trial that is designed to study the effectiveness of home-based exercise program and high dietary protein counselling in preventing frailty among elderly in Singapore primary care setting. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Frailty
- What is being tested?
- counselling on home-based exercise program and dietary protein intake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSingapore
- Study dates
- 18 Apr 2024to 18 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 - 100 years old
- Community dwelling
- On chronic disease follow up with polyclinic
- Ability to communicate in English or Mandarin
- Able to understand the study and give consent
Who cannot join
- Individuals with existing dietitian/ physiotherapy intervention (Individuals who are already seeing dietitian for special delivery requirements, or seeing physiotherapist for musculoskeletal exercises for specific condition or injury)
- Institutionalized individuals
- Individuals with significant medical conditions limiting their physical activity or high protein diet, such as severe heart conditions, recent strokes, active malignancy, chronic kidney disease stage 3-5 etc.
- Terminal illness with life expectancy < 12 months
- severe audiovisual impairment
- Not able to communicate in English or Mandarin
- Pregnant women ( as population involves participants beyond childbearing age, investigators do not expect to include pregnant women in this study)
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Ang Mo Kio Polyclinic
Singapore, Singapore, 569666
Pui Mun Liew, MBBS
About this study
Official title: EPPIC Trial: Exercise Program and Protein Intake Counselling for Frailty Prevention in Singapore
This is a randomized controlled trial that is designed to study the effectiveness of home-based exercise program and high dietary protein counselling in preventing frailty among elderly in Singapore primary care setting.
Read the detailed description
The investigators are studying the elderly population who have prefrailty (Fried Frailty). Participants include those who are: a) Aged 65 to 100 years old b) screened CFS 3-4. Patients will be approached via phone call by care coordinators, as part of the routine care. As part of the routine care to our chronic patients, care coordinators identify eligible patients for annual screening to update personal particulars/ cancer screening and vaccination statuses as per the Healthier SG program before patient's chronic disease appointment. Also as part of the routine care, care coordinators will screen for CFS 3 and 4 patients over the phone. Patients who fulfil CFS 3 and 4 will be arranged to have a physical consultation with care coordinators on their day of prescheduled visit in the clinic. Patients meeting the eligibility criteria for the study, will be approached by the care coordinator to ask for research interest. If interested in participating, patients will be referred to the research team member for recruitment and consent will be taken. Participants will then be randomly assigned to "intervention" or "usual care" parallel arms. Randomisation of participants will be done on 1:1 allocation to intervention or usual care by a simple randomisation procedure. Participants randomly assigned to the usual care group will receive normal primary care, including dietitian and physiotherapy services if needed. Intervention participants will receive the described intervention on top of usual care. Intervention participants will be taught specific resistance and balance exercises and participants will receive a leaflet with pictorial guide on the home based exercise regime. The participants will be advised to consume adequate protein and participants will also receive another leaflet on protein consumption as part of a balanced diet. At the 3 month and 12 month mark, participants in the intervention group will see the care coordinator who will assess compliance and re-enforce the exercise regime and dietary protein intake counselling, and check for any difficulties faced.
- Conditions
- Frailty
- Being tested
- counselling on home-based exercise program and dietary protein intake
- Keywords
- frailty, pre-frailty, primary care, exercise, high protein diet, nutrition
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counselling on home-based exercise program and dietary protein intakeBehavioural
Participants in the intervention group will be on a home-based exercise program and go through counselling on dietary protein intake with the aim of achieving prevention of frailty status. Participants will be required to attend the 3 study visits throughout the study period. Research procedures include physical measurements (eg. Weight, height, waist and hip circumference, calf circumference, hand grip strength, blood pressure, short physical performance battery tests), administration of questionnaires on sociodemographics, physical activity, dietary habits, smoking, alcohol, health conditions, health-related quality of life, clinical frailty status and sarcopenia screening. At three months and twelve months, the intervention group participants will see the care coordinators who will check their compliance to the exercise programme and high protein diet, reinforce the interventions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants randomly assigned to the intervention group will be taught specific resistance, balance and aerobic exercises by the care co-ordinator and participants will receive a leaflet with pictorial guide on the home-based exercise regime. The participants will be given a monitoring log to record the date and frequency of exercise they do. The participants will be advised to consume adequate protein and they will also receive another leaflet on protein consumption as part of a balanced diet. Receives: Behavioral: counselling on home-based exercise program and dietary protein intake |
| Usual Care | No intervention | Participants in the control group will receive usual care at the polyclinic which does not include counselling on dietary protein intake and home-based exercise program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeated Chair Rise Test
Measured with repeated chair rise test which is a functional performance frailty metric. As the intervention is more exercise based, the primary outcome will be able to capture the changes brought about by the intervention.
Measured: Baseline, 3 months, 12 months
Secondary outcomes (6)
Clinical Frailty Scale (CFS)
The CFS is a scale that ranges from 1 to 9, with each number representing a different level of frailty, depending on the physical activity level, fatigue level and functional level of the participant. The care-coordinator will assign a CFS score after a brief assessment of the participant. Additionally, the participant will also completed a self-rated CFS questionnaire (CFS-self) that will rate their CFS level. CFS 1 is very fit, with progressive frailty status down the scale to maximum CFS 9 for terminally ill.
Measured: Baseline, 3 months, 12 months
Short Physical Performance Battery (SPPB)
The SPPB (score range 0-12) consists of chair-stand, gait speed and standing balance. In the balance test, the participant will be made to stand in three different feet positions (side-by-side, semi-tandem, tandem) for 10 seconds each and will be scored for how long they are able to hold that position. The gait speed test will score the participants based on how long they take to walk three meters. Lastly, the chair rise test will score the participants on how long they take to complete five raises from a seated position in a chair.
Measured: Baseline, 3 months, 12 months
Health-related Quality of life
Measured by the EuroQoL 5 Dimensions - 5L (EQ5D-5L) and the EuroQoL 5 Visual Analogue Scale (EQ5D-VAS). The EQ5D-5L consists of two components, the first component is the healthstate Utility Index (UI). It measures five dimensions of health-related quality of life (mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression) on a five-point severity scale (no problems, slight problems, moderate problems, severe problems and extreme problems). The Singapore time trade-off values will be used to convert the information into UI scores, with -0.790 being the worst health state and 1.000 being the best health state. The second component of the EQ5D is the visual analogue scale (VAS) which consists of a scale from 0 to 100. It assesses self-perceived global levels of health, with 0 representing the worst imaginable health state and 100 the best imaginable health state.
Measured: Baseline, 3 months, 12 months
Sarcopenia
According to the Asian Work Group of Sarcopenia (AWGS) 2019 criteria, which is SARC-Calf more than or equal to 11 and poor handgrip strength (<28kg for men and <18kg for women). The SARC-Calf is a combination of assessments for the SARC-F questionnaire and calf-circumference. The SARC-F questionnaire has 5 items measuring self-reported strength, assistance in walking, difficulty rising from a chair, difficulty in climbing stairs, and falls in the past year. Each item requires a response of "None" or "Some" or "Great difficulty", except for the last item on falls which has responses of "None" or "1-3 falls" or "4 or more falls". The calf circumference measures the maximum value of both calves using a non-elastic tape, with a cut-off of <34cm for men and <33cm for women for sarcopenia case finding. Each item of the SARC-Calf is scored 0-2 and the items are summed together to give a total score.
Measured: Baseline, 3 months, 12 months
Physical activity
Measured by International physical activity questionnaire (IPAQ). 3.3 METs for low level, 4.0 METs for moderate level, and 8.0 METs high level of physical activity.
Measured: Baseline, 3 months, 12 months
Dietary Protein Intake
Measured by 24-hour dietary recall and food frequency on protein sources. Participants will be asked to recall the food or drink they consumed the previous day in detail. The information collected will be analyzed to quantify daily protein intake in grams. Additionally, participants will be asked to complete a brief food frequency questionnaire on various protein sources.
Measured: Baseline, 3 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start18 Apr 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion18 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants meeting the eligibility criteria, will be approached by the care coordinator. If interested in participating, they will be referred to the research team member for recruitment and consent will be taken. Participants will then be randomly assigned to "intervention" or "usual care" parallel arms. Randomisation of participants will be done on 1:1 allocation to intervention or usual care using block randomisation. Allocation will be concealed using opaque envelopes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Healthcare Group Polyclinics
- Sponsor type
- Other government
- Collaborators
- National Healthcare Group, Singapore
- Responsible party
- Sponsor
- Investigators
- Liew Pui Mun Doctor, MBBS, Principal investigator, National Healthcare Group Polyclinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418425
- Sponsor's protocol ID
- 2023/00860
- Other IDs
- EPHF-C/2023/POV/S/4, 2023
- Acronym
- EPPIC
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Serra-Prat M, Sist X, Domenich R, Jurado L, Saiz A, Roces A, Palomera E, Tarradelles M, Papiol M. Effectiveness of an intervention to prevent frailty in pre-frail community-dwelling older people consulting in primary care: a randomised controlled trial. Age Ageing. 2017 May 1;46(3):401-407. doi: 10.1093/ageing/afw242.
PubMed 28064172Travers J, Romero-Ortuno R, Bailey J, Cooney MT. Delaying and reversing frailty: a systematic review of primary care interventions. Br J Gen Pract. 2019 Jan;69(678):e61-e69. doi: 10.3399/bjgp18X700241. Epub 2018 Dec 3.
PubMed 30510094
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPPIC Trial: Exercise Program and Protein Intake Counselling for Frailty Prevention in Singapore
- ClinicalTrials.gov ID
- NCT06418425
- Acronym / sponsor ID
- EPPIC / 2023/00860
- Conditions
- Frailty
- Keywords
- frailty, pre-frailty, primary care, exercise, high protein diet, nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- National Healthcare Group PolyclinicsOther government
- Collaborators
- National Healthcare Group, Singapore
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 18 Apr 2026 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial that is designed to study the effectiveness of home-based exercise program and high dietary protein counselling in preventing frailty among elderly in Singapore primary care setting.
Detailed description
The investigators are studying the elderly population who have prefrailty (Fried Frailty). Participants include those who are: a) Aged 65 to 100 years old b) screened CFS 3-4. Patients will be approached via phone call by care coordinators, as part of the routine care. As part of the routine care to our chronic patients, care coordinators identify eligible patients for annual screening to update personal particulars/ cancer screening and vaccination statuses as per the Healthier SG program before patient's chronic disease appointment. Also as part of the routine care, care coordinators will screen for CFS 3 and 4 patients over the phone. Patients who fulfil CFS 3 and 4 will be arranged to have a physical consultation with care coordinators on their day of prescheduled visit in the clinic. Patients meeting the eligibility criteria for the study, will be approached by the care coordinator to ask for research interest. If interested in participating, patients will be referred to the research team member for recruitment and consent will be taken. Participants will then be randomly assigned to "intervention" or "usual care" parallel arms. Randomisation of participants will be done on 1:1 allocation to intervention or usual care by a simple randomisation procedure. Participants randomly assigned to the usual care group will receive normal primary care, including dietitian and physiotherapy services if needed. Intervention participants will receive the described intervention on top of usual care. Intervention participants will be taught specific resistance and balance exercises and participants will receive a leaflet with pictorial guide on the home based exercise regime. The participants will be advised to consume adequate protein and participants will also receive another leaflet on protein consumption as part of a balanced diet. At the 3 month and 12 month mark, participants in the intervention group will see the care coordinator who will assess compliance and re-enforce the exercise regime and dietary protein intake counselling, and check for any difficulties faced.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants meeting the eligibility criteria, will be approached by the care coordinator. If interested in participating, they will be referred to the research team member for recruitment and consent will be taken. Participants will then be randomly assigned to "intervention" or "usual care" parallel arms. Randomisation of participants will be done on 1:1 allocation to intervention or usual care using block randomisation. Allocation will be concealed using opaque envelopes.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: counselling on home-based exercise program and dietary protein intakeParticipants randomly assigned to the intervention group will be taught specific resistance, balance and aerobic exercises by the care co-ordinator and participants will receive a leaflet with pictorial guide on the home-based exercise regime. The participants will be given a monitoring log to record the date and frequency of exercise they do. The participants will be advised to consume adequate protein and they will also receive another leaflet on protein consumption as part of a balanced diet. |
| Usual Care | No intervention | –Participants in the control group will receive usual care at the polyclinic which does not include counselling on dietary protein intake and home-based exercise program. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 65 - 100 years old
- Community dwelling
- On chronic disease follow up with polyclinic
- Ability to communicate in English or Mandarin
- Able to understand the study and give consent
Key exclusion criteria (7 listed)
- Individuals with existing dietitian/ physiotherapy intervention (Individuals who are already seeing dietitian for special delivery requirements, or seeing physiotherapist for musculoskeletal exercises for specific condition or injury)
- Institutionalized individuals
- Individuals with significant medical conditions limiting their physical activity or high protein diet, such as severe heart conditions, recent strokes, active malignancy, chronic kidney disease stage 3-5 etc.
- Terminal illness with life expectancy < 12 months
- severe audiovisual impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| counselling on home-based exercise program and dietary protein intakeParticipants in the intervention group will be on a home-based exercise program and go through counselling on dietary protein intake with the aim of achieving prevention of frailty status. Participants will be required to attend the 3 study visits throughout the study period. Research procedures include physical measurements (eg. Weight, height, waist and hip circumference, calf circumference, hand grip strength, blood pressure, short physical performance battery tests), administration of questionnaires on sociodemographics, physical activity, dietary habits, smoking, alcohol, health conditions, health-related quality of life, clinical frailty status and sarcopenia screening. At three months and twelve months, the intervention group participants will see the care coordinators who will check their compliance to the exercise programme and high protein diet, reinforce the interventions. | Behavioural | Intervention |
Primary outcome
Repeated Chair Rise Test
Time frame: Baseline, 3 months, 12 months
Measured with repeated chair rise test which is a functional performance frailty metric. As the intervention is more exercise based, the primary outcome will be able to capture the changes brought about by the intervention.
6 secondary outcomes
Clinical Frailty Scale (CFS)
Time frame: Baseline, 3 months, 12 months
Short Physical Performance Battery (SPPB)
Time frame: Baseline, 3 months, 12 months
Health-related Quality of life
Time frame: Baseline, 3 months, 12 months
Sarcopenia
Time frame: Baseline, 3 months, 12 months
Physical activity
Time frame: Baseline, 3 months, 12 months
Dietary Protein Intake
Time frame: Baseline, 3 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Background: PubMed 28064172Serra-Prat M, Sist X, Domenich R, Jurado L, Saiz A, Roces A, Palomera E, Tarradelles M, Papiol M. Effectiveness of an intervention to prevent frailty in pre-frail community-dwelling older people consulting in primary care: a randomised controlled trial. Age Ageing. 2017 May 1;46(3):401-407. doi: 10.1093/ageing/afw242.
- Background: PubMed 30510094Travers J, Romero-Ortuno R, Bailey J, Cooney MT. Delaying and reversing frailty: a systematic review of primary care interventions. Br J Gen Pract. 2019 Jan;69(678):e61-e69. doi: 10.3399/bjgp18X700241. Epub 2018 Dec 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liew Pui Mun Doctor, MBBS principal investigator
National Healthcare Group Polyclinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing counselling on home-based exercise program and dietary protein intake in people with Frailty, run by National Healthcare Group Polyclinics at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liew Pui Mun Doctor, MBBS (63553000, pui_mun_liew@nhgp.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repeated Chair Rise Test (time frame: Baseline, 3 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06418425, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.