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临床试验/NCT06418425
NCT06418425招募中不适用

EPPIC Trial: Exercise Program and Protein Intake Counselling for Frailty Prevention in Singapore

National Healthcare Group Polyclinics2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年4月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
240
试验地点
2
主要终点
Repeated Chair Rise Test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Research coordinator who assesses the outcomes will be blinded. This clinical research coordinator is different from the one taking the informed consent and performing the randomisation.

入排标准

年龄范围
65 Years 至 100 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Repeated Chair Rise Test

时间窗: 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.

次要结局

  • Clinical Frailty Scale (CFS)(Baseline, 3 months, 12 months)
  • Health-related Quality of life(Baseline, 3 months, 12 months)
  • Dietary Protein Intake(Baseline, 3 months, 12 months)
  • Physical activity(Baseline, 3 months, 12 months)
  • Short Physical Performance Battery (SPPB)(Baseline, 3 months, 12 months)
  • Sarcopenia(Baseline, 3 months, 12 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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