key: cord-0820876-knqrd3on authors: Chew, Kimberly Ann; Xu, Xin; Siongco, Paula; Villaraza, Steven; Phua, April Ka Sin; Wong, Zi Xuen; Chung, Chooi Yu; Tang, Ning; Chew, Effie; Henry, Christiani Jeyakumar; Koo, Edward; Chen, Christopher title: SINgapore GERiatric intervention study to reduce physical frailty and cognitive decline (SINGER)–pilot: A feasibility study date: 2021-03-15 journal: Alzheimers Dement (N Y) DOI: 10.1002/trc2.12141 sha: 2bfbd49a5eed25d479b6e1d8567092dc545fba44 doc_id: 820876 cord_uid: knqrd3on INTRODUCTION: The SINGER pilot randomized controlled trial aims to examine the feasibility and acceptability of the Finnish Geriatric Intervention Study (FINGER) multi‐domain lifestyle interventions compared to Singaporean adaptations. METHODS: Seventy elderly participants were recruited and randomized into FINGER (n = 36) or SINGER (n = 34) interventions; involving physical exercise, cognitive training, diet, and vascular risk factors management, for 6 months. RESULTS: Both intervention groups were equally feasible and acceptable with participants completing at least 80% of the interventions. Body strength improved in both groups (P(upper body) = .04, P (lower body) = .06, P (core) = .05). More participants in the SINGER group attained good blood pressure control at month‐6 compared to FINGER (41% vs 19%; P = .06). DISCUSSION: This study is the first to compare the feasibility of multi‐domain interventions adapted to local culture with the FINGER interventions. The findings will be utilized for a larger study to provide evidence for the efficacy of multi‐domain lifestyle interventions in preventing cognitive decline. The prevalence of cognitive impairment and dementia is rising globally, 1 with Asia having the most rapidly ageing societies worldwide. Consequently, there will be a marked increase in the prevalence of cognitive impairment which is associated with poor long-term health outcomes, such as hospitalization and dependency in daily activities. 2 In Singapore, a multicultural Asian country, dementia prevalence is projected to increase exponentially due to a rapidly ageing population from 12.4% above the age of 65 in 2019 to 33.3% in 2050. 3, 4 Such an increase will put an enormous strain on societies. Therefore, the challenge lies in the development of safe and effective interventions that can prevent and reduce cognitive impairment. In recent years, there has been a shift from pharmacological treatment after symptom onset to non-pharmacological interventions that may help prevent and delay the emergence of symptoms. Compared to pharmacological interventions, non-pharmacological interventions are less expensive and invasive with fewer side effects. 5 Several promising non-pharmacological multi-domain interventions have been studied, [6] [7] [8] yet not all have yielded positive efficacy outcomes. Hence, illustrating the importance of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) trial, which has produced promising results. 8 The FINGER study, a population- cultural, and economic settings. 9 As part of the WW-FINGERS initiative, the SINgapore GERiatric intervention study to reduce physical frailty and cognitive decline (SINGER) was designed as a proof-of-concept pilot study testing a series of multi-domain interventions adapted from the original FINGER study. This trial will help determine the cultural feasibility and practicality of the adaptations in a multi-ethnic Asian community, as a precursor to expand into a large-scale community-based RCT to determine the efficacy of such interventions in delaying cognitive decline and pre- The SINGER pilot study is a 6-month RCT conducted at the National After obtaining informed consent, participants were randomized into the FINGER intervention or the SINGER intervention in a 1:1 ratio. Randomization was computer-generated by random allocation sequence. F I G U R E 2 Timeline of study period affected by the COVID-19 pandemic All participants completed screening and outcome measures at baseline, month-3 and month-6 ( Figure 1 ). The study team attended to all participants at all 3 time points for a detailed medical history and examination. Figure 2 Blood pressure management by study team followed SPRINT protocol guidelines. 12, 13 Blood pressure management by primary healthcare followed national healthcare guidelines. 11 heart disease, defined as a previous diagnosis of myocardial infarction, congestive heart failure, atrial fibrillation, or intervention procedures such as angioplasty, or stenting; and history of smoking (ever/never). Participants also provided self-reported information on lifestyle factors at baseline. Level of independence was measured on a five-point Likert scale, and subjective memory complaints was measured on a yes/no scale. Previous diagnosis of major depression and/or other major psychiatric disorders were also recorded and reported. Lifestyle interventions were conducted in two blocks -the first (Table 1 ). More details of the individual interventions can be found in Appendix A. Interventions and outcome measures were conducted in the participant's primary language. The following measures were used to assess the compliance to the study interventions: The following measures were used to evaluate the efficacy of the study interventions: • Diet and vascular management: Diet and vascular risk factor man- Descriptive statistics were performed to determine participants' demographics such as age, sex and education ( Seventy-one participants were recruited between October 2018 and April 2020. Of which, one did not meet inclusion criteria hence 70 participants were randomized -36 into FINGER and 34 into the SINGER intervention, with a mean age of 74 years in the whole sample (Table 2) . Two participants withdrew consent before interventions began, resulting in a total of 68 participants who completed the study (Figure 1 ). FINGER group participants were more educated than the SINGER group, and were more hypertensive (P < .05). Notably, while all participants completed month-6 BP measurement, 12 of them recorded their BP at home via teleconsultation (due to COVID-19 pandemic) with the study doctor ensuring that the BP measurement followed the SPRINT protocol (n FINGER = 7, n SINGER = 5). There was no difference in BP measurements between subjects who measured their BP in clinic versus at home (P > .05). Overall, there was no difference between groups in terms of the feasibility of the exercise, diet and vascular risk factor interventions in a Singaporean population ( Upper body strength z-score 0.0 ± 1.0 0.2 ± 1. Though there was no significant difference between groups in intervention effectiveness (P > .05), average performance improved across the 6 months regardless of grouping. Specifically, upper body strength improved (P upper body = .04) while lower body and core strength trended to significance respectively (P lower body = .06; P core = .05). Notably, we found a positive trend where more in SINGER attained overall good BP outcome at month-6 compared to the FINGER group (41% vs 19%; P = .06; Figure 3 ). Further analysis showed that subjects in SINGER with poor BP at baseline were driving this trend towards good BP outcome at month-6. Hyperlipidemia (HLD) and diabetes mellitus (DM) were well-controlled in both FINGER and SINGER groups, with good outcomes at month-6 (89% vs 97%, 64% vs 75% respectively; P > .05). Adherence to exercise, diet, vascular and cognitive training interventions between subjects in the FINGER and SINGER groups from baseline to month-6 Home-based exercise The effects of the lifestyle interventions on clinical outcomes suggest that participants are trending to improvement regardless of whether they were assigned to the FINGER or SINGER lifestyle interventions. Our findings thus suggest that a multi-domain lifestyle intervention has positive effects on mild-to-moderately frail older adults. Supporting this is an RCT consisting 246 pre-frail and frail older adults in Singapore that delivered cognitive training, nutritional intervention and a combination of both alongside physical training over 6 months, and were found to improve cognition over time. 16 Though Ng et al. 16 utilized a series of lifestyle interventions similar to the SINGER study, a vascular management component was not included. While the vascular management clinical outcomes (eg, BP, cholesterol) did not show any significant improvement, this was due to the short study duration. Although there was no difference between groups in good HLD and DM outcomes at month-6, these vascular risk factors were generally well-controlled in both groups. Our sample has a higher prevalence of hypertensive elderly compared to the Singaporean general population (76% vs 49% to 66%). 17 We found a trend towards better BP outcome at month-6 in the SINGER group, suggesting that close monitoring of BP is vital in attaining improved outcomes compared to general management in the primary healthcare system. Interestingly, further analysis demonstrated that subjects with poor baseline BP in SINGER were driving this trend as they had better BP outcomes compared to those Our study has strengths and weaknesses. This is the first to evaluate the feasibility of the FINGER interventions in a multi-ethnic population. By implementing an RCT design, we were able to compare the established FINGER interventions with locally modified SINGER interventions and illustrate the cultural acceptance and feasibility of both sets of interventions. Moreover, our study followed a rigorous protocol, with blinded raters assessing comprehensive outcome measurement. Extensive considerations for intervention materials such as thumbdrives for the FINGER home-based cognitive training, and light weights for the home-based exercise training were also taken into account. Conversely, one limitation is the short period of time for intervention. We only provided interventions for 6 months, which may be too short to obtain a more robust secondary measurement of intervention efficacy. Nonetheless, as our primary outcome is feasibility, the intervention period was deemed sufficient. Nevertheless, even with a shorter intervention period, we were able to establish superiority in BP management for the SINGER intervention, highlighting the importance of having a dedicated study physician to monitor BP compared to leaving it to the general healthcare system. Other limitations include the small sample size and the lack of a control (general health management) group to evaluate the efficacy of the SINGER intervention. This will be addressed in a larger-scale trial that will be developed. Future studies should include more biomarkers of ageing, such as blood and imaging biomarkers, as well as quality of life assessments for both participants and caregivers, to determine a more comprehensive presentation of the intervention outcomes. Our study has found that the SINGER vascular management and both types of cognitive training, physical exercise and diet interventions are feasible in Singapore. It is therefore essential to develop a larger RCT with at least 2 years of interventions such as the original FINGER study to further evaluate the efficacy of these interventions on cognition in older adults in Singapore. In conclusion, our study evaluated the feasibility and efficacy of the SINGER lifestyle interventions, which were adapted from the FINGER lifestyle interventions. We found that the FINGER lifestyle interventions were as feasible as the SINGER interventions in a Singaporean population of older adults. Furthermore, we found that all interventions were effective over the 6 months regardless of intervention group. Of note, more subjects in SINGER achieved good BP control than those in FINGER in 6 months, illustrating the effectiveness of close monitoring by a study physician. None declared. • Soy milk (substitute for milk) • Lean meat, bean products (tofu) and less saturated fat • Peanut, sunflower and canola, rice bran oils (avoid frying) • Almonds and walnuts • Consumption of two portions of fish/fish oil supplementation and tofu per week • Less added sugar and salt. The group sessions took ≈ 60-90 minutes and included topics on a healthy meal/plate, healthy food choices and reading food labels. The individual sessions (30-minutes) were adapted and personalized to each participant's needs identified by the nutritionist. 3-day food diaries (2 weekdays, 1 weekend) were completed by participants at baseline, month-3 and month-6. Participants attended two groupbased nutritional sessions and two individual nutritional sessions over the first 3 months. A diet compliance score was generated using the participants' food diaries and were based on a specific criterion (Figure 1 ). The SINGER exercise programme consisted of supervised strength and aerobic exercise classes. Both occurred twice weekly over 12 weeks. The supervised strength class comprised of: • Stretching (5 minutes) • Balance training (10 minutes) • Strengthening (30 to 45 minutes) ∘ 10 reps of 10 Repetition Maximum (RM) of major muscle groups using free weights, TheraBands and weights machine The supervised 30-minutes aerobic exercise class were recommended twice weekly and required a minimum Heart Rate Reserve (HRR) of 55% at the start of the study. The target HRR after 2 months is 75%. Individualized home-based programmes were also provided to all subjects for them to complete muscle strength training and aerobic exercise for a recommended twice weekly. Subjects recorded their activities in an exercise diary. The SINGER cognitive intervention programme comprised of individual sessions and group-based sessions. Participants attended two group-based sessions consisting non-structured discussions on topics such as age-related changes in cognition, memory strategies and everyday memory training. The pen-and-paper training tasks were designed to enhance multidomain skills such as memory, executive function, attention and processing speed. There were three levels in total, with 24 sessions within one level. Each session comprised of four tasks. There were two different sets of the four tasks and these sets switched every four sessions. Participants advanced to a higher level of difficulty after 24 sessions. Level advancements aimed to reduce practice effects and adjust to participants' cognitive abilities. Participants were provided with the instructions for each task at every session. Participants attended a minimum of three study team visits (ie, baseline, month-3, month-6). Participants in the FINGER group had their vascular risk factors managed by their primary healthcare physicians. They were advised by the study team at baseline, month-3 and month-6 follow-ups to contact their primary physician if further management such as high BP was required. Meanwhile, subjects in the SINGER group had their medical care transferred to the study physician for the duration of the study. Therefore, changes in medications were also handled by the study physician. BP of the SINGER group was managed by the study physician, who followed the SPRINT protocol guidelines for clinical management of BP (ie, good BP control defined as ≤120 mmHg). World Health Organisation. Dementia. 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Cardiovascular disease, chronic kidney disease, and diabetes mortality burden of cardiometabolic risk factors from 1980 to 2010: a comparative risk assessment How to cite this article SINgapore GERiatric intervention study to reduce physical frailty and cognitive decline (SINGER)-pilot: A feasibility study refine products, sufficient intake of vegetables, fruits and protein, fish consumption at least twice a week, reduce consumption of added sugar in food/drinks and choosing low fat option. The SINGER diet intervention followed the FINGER dietary component criteria High consumption of Asian fruits and vegetables (eg, kai lan, guava, papaya) Whole grain rice including brown rice; consumption of oats, wholemeal bread