Clinical trial NCT06418425: Exercise Program and Protein Intake Counselling for Frailty Prevention in Singapore
Official title: EPPIC Trial: Exercise Program and Protein Intake Counselling for Frailty Prevention in Singapore
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Keywords: frailty
pre-frailty
primary care
exercise
high protein diet
nutrition
Lead sponsor: National Healthcare Group Polyclinics
Sponsor class: OTHER_GOV
Collaborators: name: National Healthcare Group, Singapore
First posted: 2024-05-17
Enrollment: 240
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Repeated Chair Rise Test
timeFrame: Baseline, 3 months, 12 months
Secondary outcomes:
measure: Clinical Frailty Scale (CFS)
timeFrame: Baseline, 3 months, 12 months
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline, 3 months, 12 months
measure: Health-related Quality of life
timeFrame: Baseline, 3 months, 12 months
measure: Sarcopenia
timeFrame: Baseline, 3 months, 12 months
measure: Physical activity
timeFrame: Baseline, 3 months, 12 months
measure: Dietary Protein Intake
timeFrame: Baseline, 3 months, 12 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Ang Mo Kio Polyclinic
Study officials:
affiliation: National Healthcare Group Polyclinic
name: Liew Pui Mun Doctor, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Travers 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.