Randomized Controlled Trial of Community-based Nutritional, Physical and Cognitive Training Intervention Programmes for At Risk Frail Elderly
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Frailty score (continuous variable)
研究概览
简要总结
The aims of this proposed community-based randomized controlled trial are to evaluate the effectiveness of nutritional, physical exercise and cognitive training interventions for at-risk and frail elderly, to elucidate the biological determinants and changes associated with frailty, and to develop, evaluate and demonstrate the feasibility of screening instruments for frailty.
详细描述
Community-living elderly persons are screened and 250 participants satisfying rigorous criteria for frailty are randomized to received nutritional, physical training, cognitive training, combined or control arms for 24 weeks and followed up for 12 months. Baseline evaluations will include an extensive range of potential markers of frailty and outcome measures, including functional disability and hospitalizations.
Frail subjects who were selected for the interventional trial (N=250) are followed up at 3, 6 and 12 months after baseline assessment. Non-trial subjects (about 2750) are followed up at 1 year after baseline assessment
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 89 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of 65 years or older
- •Living at home
- •Able to walk without personal assistance and no other physical limitations that can limit participation and adherence, particularly to exercise intervention programme
- •Meet criteria for frailty
- •Operational definition of frailty.
- •The participants are assessed and classified on the level of frailty by the following measures and criteria:
- •Weight loss
- •Poor balance and weakness assessed by chair stand test
- •Muscle weakness assessed by hand grip and knee extension strength
- •Exhaustion, fatigue or low endurance
- •Low physical activity
排除标准
- •Member of household already enrolled
- •Dementia or cognitive impairment, major depression or other psychotic disorders
- •Severe audio-visual impairment
- •Progressive, degenerative neurologic disease like Parkinsonism, fits/ epilepsy, etc
- •Rapidly progressive or terminal illness under palliative care with life expectancy less than 12 months
- •History of alcohol abuse or any other substance abuse
- •Severely affect muscle/joint dysfunction resulting in disability
- •Hospital admission in the past 3 months
- •Regular physical training or physiotherapy or current participation in a vigorous exercise or weight-training program more than once per week
- •Undergoing therapeutic diet incompatible with nutritional supplementation
- •In the opinion of research clinician, the intervention is deemed to be potentially hazardous for the subject, such as serious cardiac and pulmonary disease.
结局指标
主要结局
Frailty score (continuous variable)
时间窗: 12 months
Measures of frailty components (BMI, fast gait speed test, knee extension, exhaustion score and time spent on physical activities per day).
时间窗: 12 months
Reduction of frailty
时间窗: 12 months
次要结局
- Mortality(12 months)
- Frequency of falls (defined as an event resulting in a person coming to rest unintentionally on the ground or other lower level; near-falls are not included; Robertson, 2001).(12 months)
- Health service utilization (frequencies of doctor visits, emergency room visit, hospitalization, nursing home admission)(12 months)
- Disability in activities of daily living (ADL) and instrumental activities of daily living (IADL).(12 months)
研究者
Ng Tze Pin
Associated professorial fellow
National University of Singapore