Promoting Health LongevIty Through Mitigation and Prevention of Frailty in Community-dwelling Elderly (Pro-LIFE)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Change in physical performance measures among pre-frail older adults following a 4-month exercise and nutrition intervention programme
研究概览
简要总结
The current healthcare response to frailty has been mainly reactive to acute health crises of the elderly. With its insidious onset and progression, frailty is often not apparent unless actively sought. Well-validated models of frailty already exist and, instead of trying to create new frailty criteria or insisting on a universal approach to measuring frailty, it is needed to move on to higher levels of care systems supporting their practical implementation, mapping the chosen frailty instrument to its specific role. This pragmatic study will equip older persons with awareness of their frailty status through community-based screening, allowing for timely stage-specific care to avoid deleterious outcomes. While older persons meeting frailty criteria will be referred for comprehensive geriatric assessment, pre-frail older persons will be targeted for multi-factorial exercise and nutritional intervention in the community to reverse the frailty trajectory. An over-arching aim will be to create a sustainable triaging system and early intervention programme that can be administered by trained members of the community. This will allow older persons to receive regular re-assessments in the community such that any transitions to a higher state of frailty may be captured and promptly addressed.
详细描述
This is a non-controlled prospective cohort study, recruiting community-dwelling older persons aged >55 years, from various senior activity centres, day care and community centres in the North-East region of Singapore. A mobile community-based platform for frailty and physical fitness assessment will be anchored at the void decks of public housing blocks, senior activity centres (SACs), senior care centres (SCCs) or community clubs for accessibility. The platform will be maintained at each site for 2-3 consecutive weeks, and is managed by members of the multidisciplinary team, with the same site being re-visited at yearly intervals to allow follow-up. Each participant undergoes a multi-domain geriatric screen and physical fitness assessment, and will be triaged by physical frailty status for stage-specific care.
Written informed consent will be obtained from all participants, and ethics approval has been obtained from the Institutional Review Board of Singhealth.
Measures Multi-domain geriatric screen The multi-domain geriatric screen includes assessment of (i) socio-demographic characteristics (including social support network, socio-economic status, education and employment); (ii) mood as assessed using the 15-item Geriatric Depression Scale; (iii) cognitive performance using the locally validated modified Chinese version of Mini Mental State Examination (CMMSE); (iv) nutrition using the Mini Nutrition Assessment-Short Form (MNA-SF) and Subjective Global Assessment (SGA); (iv) physical activity level based on a structured questionnaire to assess the time spent on physical activities over the last 7 days; (v) functional performance using Barthel's Index for activities of daily living (ADLs) and Lawton and Brody's instrumental ADLs, as well as Life Space Questionnaire (LSQ) for functional mobility; (vi) quality of life on EuroQol 5 dimensions (EQ-5D-5L) questionnaire and a visual analogue scale; (vii) sarcopenia using SARC-F questionnaire enquiring ability to carry a heavy load, walking, rising from a chair, climbing stairs and falls, has been validated as a suitable tool for community screening for sarcopenia.
Frailty Assessment Frailty screening will be based on the 5-item FRAIL scale, which assesses for self-reported fatigue, resistance, ambulation, illnesses and loss of weight, to categorize participants as frail (score 3-5), pre-frail (1-2) or robust (0).
Physical frailty will be objectively assessed using modified Fried's criteria, with frailty defined by the presence of at least 3 and pre-frailty as 1-2 of 5 components - exhaustion, slow gait speed, weak grip strength, low body mass index (BMI<18.5kg/m2) and low physical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •any community-dwelling adult aged 55 and above
- •able to ambulate independently (use of walking aids permitted)
排除标准
- •For the pre-frail intervention programme, older adults with significant cognitive impairment, as defined using age- and education-adjusted local norms on the modified Chinese version of the Mini-Mental State Examination (CMMSE) will be excluded
结局指标
主要结局
Change in physical performance measures among pre-frail older adults following a 4-month exercise and nutrition intervention programme
时间窗: End of intervention (7-month)
Physical performance measures include grip strength, gait speed (time taken to 10-m walk at usual pace), lower limb strength (time taken to complete 5 chair stands and number of chair stands completed in 30-seconds), upper and lower limb flexibility (back-scratch test and modified sit-and-reach test), upper limb dexterity (box-and-block test), tandem and dynamic balance (Timed-Up-and-Go test), and cardiorespiratory endurance (6-minute walk test). Cut-off values for tests of gait speed, balance and chair-stand will be applied to derive a score on the Short Physical Performance Battery as a composite measure of physical performance.
Frailty Prevalence in Community-dwelling older adults
时间窗: Baseline
Prevalence of pre-frailty and frailty in community-dwelling older adults aged \>55 years who attend frailty screening. Frailty will be measured using the 5-item FRAIL questionnaire, which assesses for self-reported fatigue, resistance, ambulation, illnesses and loss of weight. 1 point is assigned for each positive response, and participants are categorized as frail (score 3-5), pre-frail (1-2) or robust (0). Agreement of the FRAIL scale with established frailty measures - Fried Phenotype and Frailty Index (35-item) will be examined.
Proportion of pre-frail participant reverting to robustness following a 4-month multi-factorial physical exercise and nutrition intervention programme
时间窗: End of intervention (7-month)
For intervention eligibility, pre-frailty will be operationalized as: (i) FRAIL score 1-2, or (ii) FRAIL score 0 but with weak grip strength or slow gait speed based on Asian Working Group for Sarcopenia cut-offs. The proportion of pre-frail participants who revert to being robust at the end of the 4-month intervention programme will be measured.
次要结局
- Performance in physical fitness tests at 13-month (6 months post-intervention)(13-month)
- Performance in physical fitness tests at 3 month (immediate pre-intervention)(3-month)
- Performance in physical fitness tests at 7-month (immediate post-intervention)(7-month)
- Performance in physical fitness tests at 19-month (12 months post-intervention)(19-month)