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Roles of Baseline Intrinsic Capacity and its Subdomains on the Overall Efficacy of Multidomain Intervention in Promoting Healthy Aging among Community-Dwelling Older Adults: Analysis from a Nationwide Cluster-Randomized Controlled Trial.
Liang, CK, Lee, WJ, Chou, MY, Hwang, AC, Lin, CS, Peng, LN, Hsiao, FY, Loh, CH, Chen, LK
The journal of prevention of Alzheimer's disease. 2024;(2):356-365
Abstract
BACKGROUND Impaired intrinsic capacity (IC), which affects approximately 90% of older adults, is associated with a significantly heightened risk of frailty and cognitive decline. Existing evidence suggests that multidomain interventions have the potential to enhance cognitive performance and yield positive effects on physical frailty. OBJECTIVE To examine roles of baseline IC and its subdomains on the efficacy of multidomain interventions in promoting healthy aging in older adults. DESIGN a cluster-randomized controlled trial. SETTING AND PARTICIPANTS 1,054 community-dwelling older adults from 40 community-based clusters across Taiwan. INTERVENTION A 12-month pragmatic multidomain intervention of exercise, cognitive training, nutritional counseling and chronic condition management. MEASUREMENTS Baseline IC was measured by 5 subdomains, including cognition (Montreal Cognitive Assessment, MoCA), sensory (visual and hearing impairment), vitality (handgrip strength or Mini-Nutritional Assessment-short form), psychological well-being (Geriatric Depression Scale-5), and locomotion (6m gait speed). Outcomes of interest were cognitive performance (MoCA scores) and physical frailty (CHS frailty score) over a follow-up period of 6 and 12 months. RESULTS Of all participants (mean age:75.1±6.4 years, 68.6% female), about 90% participants had IC impairment at baseline (2.0±1.2 subdomains). After covariate adjustment using a generalized linear mixed model (GLMM), the multidomain intervention significantly prevented cognitive declines and physical frailty, particularly in those with IC impairment ≥ 3 subdomains (MoCA: coefficient: 1.909, 95% CI: 0.736 ~ 3.083; CHS frailty scores: coefficient = -0.405, 95% CI: -0.715 ~ -0.095). To assess the associations between baseline poor capacity in each IC subdomain and MoCA/CHS frailty scores over follow-up, a 3-way interaction terms (time*intervention*each poorer IC subdomains) were added to GLMM models. Significant improvements in MoCA scores were shown for participants with poorer baseline cognition (coefficient= 1.138, 95% CI: 0.080 ~ 2.195) and vitality domains (coefficient= 1.651, 95% CI: 0.541 ~ 2.760). The poor vitality domain also had a significant modulating effect on the reduction of CHS frailty score after the 6- and 12-month intervention period (6 months: coefficient= -0.311, 95% CI: -0.554 ~ -0.068; 12 months: coefficient= -0.257, 95% CI: -0.513 ~ -0.001). CONCLUSION AND IMPLICATIONS A multidomain intervention in community-dwelling older adults improves cognitive decline and physical frailty, with its effectiveness influenced by baseline IC, highlighting the importance of personalized strategies for healthy aging.
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Effect of Oral Vitamin D3 Supplementation in Exclusively Breastfed Newborns: Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.
Lin, CH, Lin, CY, Sung, YH, Li, ST, Cheng, BW, Weng, SL, Chang, SJ, Lee, HC, Lee, YJ, Ting, WH, et al
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research. 2022;(4):786-793
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Abstract
Exclusively breastfed infants are at a high risk of vitamin D deficiency. Few studies have evaluated the effects of vitamin D supplementation. Hence, we conducted a prospective randomized controlled trial investigating the effects of oral vitamin D3 400 IU/d supplementation in exclusively breastfed newborns. Serum 25-hydroxy-vitamin D (25[OH]D) levels in pregnant women and their newborns were evaluated. Breastfed newborns were randomized to one of two regimens at age 10 days. One group received vitamin D3 supplementation at a dose of 400 IU/d (vD-400 group), whereas the placebo group received a liquid product without vitamin D3. Outcomes were assessed at 4 months of age. A total of 92 pregnant women and their infants were enrolled, and the data of 72 infants (37 in the vD-400 group and 35 in the placebo group) who completed the study at 4 months of age were assessed. The results showed severe vitamin D deficiency in 15.2% of mothers before delivery, while 54.3% had vitamin D deficiency. Moreover, 15.2% of newborns presented with severe vitamin D deficiency at birth, while 52.2% had vitamin D deficiency. Maternal vitamin D levels were significantly correlated with infant vitamin D levels at birth (r = 0.816, p < 0.001). At 4 months of age, weight, head circumference, serum 25(OH)D, phosphorus, and intact parathyroid hormone levels significantly differed between the vD-400 and placebo groups. However, the body length and bone mineral density of the two groups did not differ significantly. Regardless of vitamin D supplementation, participants with severe vitamin D deficiency had significantly higher intact parathyroid hormone levels and lower bone mineral content. In conclusion, among exclusively breastfed infants, oral supplementation with vitamin D3 at a dose of 400 IU/d from age 10 days increased 25(OH)D concentrations at 4 months of age, but it did not affect bone mineralization. © 2022 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).
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Efficacy of Multidomain Intervention Against Physio-cognitive Decline Syndrome: A Cluster-randomized Trial.
Liang, CK, Lee, WJ, Hwang, AC, Lin, CS, Chou, MY, Peng, LN, Lin, MH, Chen, LK
Archives of gerontology and geriatrics. 2021;:104392
Abstract
BACKGROUNDS To investigate the efficacy of a community group-based intervention among community-dwelling older adults with physio-cognitive decline syndrome (PCDS). METHODS A prospective cluster randomized controlled trial included 733 community-dwelling older adults with adjusted Montreal Cognitive Assessment (MoCA adj) scores >18 from 40 community-based sites across Taiwan. PCDS was defined as the concomitant presence of physical declines, i.e., slowness and/or weakness plus dysfunction in any cognitive domain. The multidomain intervention integrated physical exercise, cognitive training, nutritional advices and health education lessons. Conventional health education in control group entailed periodic telephone calls to offer participants health education and advice. The primary outcome was the mean differences of MoCA adj total scores and all domains of MoCA adj between baseline and 6- and 12-month follow-up in each group of PCDS, cognitive dysfunction, mobility-type frailty and normal functioning, and the secondary outcomes included the changes of frailty score, handgrip strength, gait speed and physical activity. Intervention effects were analysed using a generalized linear mixed model. RESULTS Overall, 18.9% of the study sample had PCDS. Multidomain intervention for 12 months significantly improved cognitive performance in people with PCDS, and those with cognitive dysfunction only. An early benefit on visuo-spatial executive function was seen in older adults with mobility-type frailty. Intervention also improved frailty scores among participants with mobility-type frailty, handgrip strength for participants with PCDS, and gait speed in the normal group. CONCLUSIONS PCDS is a potentially reversible condition that may prevent subsequent disability and dementia, which deserves further investigation to confirm the long-term effects.
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Evaluation of the postoperative cognitive dysfunction in elderly patients with general anesthesia.
Chi, YL, Li, ZS, Lin, CS, Wang, Q, Zhou, YK
European review for medical and pharmacological sciences. 2017;(6):1346-1354
Abstract
OBJECTIVE The present study is aimed to study the neuron-specific enolase (NSE) and S100b proteins in the evaluation of postoperative cognitive dysfunction in elderly patients with general anesthesia. PATIENTS AND METHODS A total of 142 aged patients, who were treated with transurethral resection of the prostate (TURP) surgery under general anesthesia with propofol from June 2014 to December 2015, were randomly divided into two groups. The experiment group was given scopolamine butylbromide by intramuscular injection before the operation, while the control group had no preoperative intramuscular injection. The propofol was used for maintenance during the operation. The Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) scales were adopted for testing the patients on preoperative day 1, postoperative day 2 and postoperative day 9. After the surgery, there were 4 cases of postoperative cognitive dysfunction (POCD) patients in experiment group, while 21 cases of POCD patients in control group. While the 142 healthy adult volunteers, who were admitted to physical examination center of our hospital in the corresponding period, were selected as healthy controls. The expression levels of S100b and NSE of patients, as well as healthy controls, were detected by ELISA. RESULTS In POCD patients, serum S100b and NSE levels were evidently higher than those of patients without POCD and healthy control group (p < 0.05). S100b and NSE levels of POCD patients in experiment group were significantly lower than those of control group (p < 0.05). Serum S100b and NSE levels are higher, the longer duration of POCD is, as the correlation coefficient rs = -0.1342, -1.6644, p < 0.05. CONCLUSIONS The expression levels of S100b protein and plasma NSE in the serum of POCD patients increased, which indicated the severity of the disease. The preoperative intramuscular injection of scopolamine butylbromide has important clinical significance for the prevention of POCD.
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Flecainide in Amyotrophic Lateral Sclerosis as a Neuroprotective Strategy (FANS): A Randomized Placebo-Controlled Trial.
Park, SB, Vucic, S, Cheah, BC, Lin, CS, Kirby, A, Mann, KP, Zoing, MC, Winhammar, J, Kiernan, MC
EBioMedicine. 2015;(12):1916-22
Abstract
BACKGROUND Abnormalities in membrane excitability and Na(+) channel function are characteristic of amyotrophic lateral sclerosis (ALS). We aimed to examine the neuroprotective potential, safety and tolerability of the Na(+) channel blocker and membrane stabiliser flecainide in ALS. METHODS A double-blind, placebo-controlled, randomised clinical trial of flecainide (200 mg/day) for 32-weeks with a 12-week lead-in phase was conducted in participants with probable or definite ALS recruited from multiple Australian centres (ANZCT Registry number ACTRN12608000338369). Patients were reviewed by a cardiologist to rule out cardiac contraindications. Participants were randomly assigned (1:1) to flecainide or placebo using stratified permuted blocks by a central pharmacy. The primary outcome measure was the slope of decline of the ALS Functional Rating Scale-revised (ALS FRS-r) during the treatment period. FINDINGS Between March 11, 2008 and July 1, 2010, 67 patients were screened, 54 of whom were randomly assigned to receive flecainide (26 patients) or placebo (28 patients). Four patients in the flecainide group and three patients in the placebo group withdrew from the study. One patient in the flecainide group died during the study, attributed to disease progression. Flecainide was generally well tolerated, with no serious adverse events reported in either group. There was no significant difference in the rate of decline in the primary outcome measure ALS-FRS-r between placebo and flecainide treated patients (Flecainide 0.65 [95% CI 0.49 to 0.98]; Placebo 0.81 [0.49 to 2.12] P = 0.50). However, the rate of decline of the neurophysiological index was significantly reduced in the flecainide group (Flecainide 0.06 [0.01 to 0.11]; Placebo 0.14 [0.09 to 0.19], P = 0.02). Placebo-treated patients demonstrated greater CMAP amplitude reduction during the course of the study in the subset of patients with a reduced baseline CMAP amplitude (Flecainide: - 15 ± 12%; Placebo - 59 ± 12%; P = 0.03). Flecainide-treated patients maintained stabilized peripheral axonal excitability over the study compared to placebo. INTERPRETATION This pilot study indicated that flecainide was safe and potentially biologically effective in ALS. There was evidence that flecainide stabilized peripheral axonal membrane function in ALS. While the study was not powered to detect evidence of benefit of flecainide on ALS-FRS-r decline, further studies may demonstrate clinical efficacy of flecainide in ALS.
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[Multi-center clinical study on therapeutic effect of kunxian capsule on rheumatoid arthritis].
Lin, CS, Yang, XY, Dai, L
Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine. 2011;(6):769-74
Abstract
OBJECTIVE To assess the therapeutic efficacy and safety of Kunxian Capsule (KXC) in treatment of rheumatoid arthritis (RA). METHODS Randomized positive parallel controlled and multi-center open test method was adopted. 240 RA patients of mild/moderate degree were randomly assigned to three groups equally, i.e., KXC group (who took KXC), the methotrexate (MTX) group (who took MTX), and the KXC + MTX group (who took KXC and MTX simultaneously), respectively. The therapeutic course for them all was 12 weeks. The effect of the treatment was assessed in items of DAS28, ACR20, and ACR50; number of joints with pain and swelling; VAS score of pain, tiredness, and general condition; time of morning stiffness; bilateral grip strength; HAQ score, as well as blood levels of erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), rheumatoid factor (RF), anti-CCP antibody, and platelet count. RESULTS By the end of the 4th week, the improvement of ACR20, ACR50, DAS28 efficacy judgment, and DAS28 score in the KXC + MTX group were much better than those in the other two groups, with statistical difference (P<0.05). The total effective rate was 88. 6% and the markedly effective rate was 51.8% in the KXC + MTX group at the 12 th week. The Improvement was more obviously shown in all groups after treatment (all P<0.05). Better effects in reducing VAS scores of pain and tiredness were shown in the KXC group and the KXC + MTX group. The effects of KXC + MTX were superior to the other two groups in terms of swollen joint numbers, pain joints, grip strength (assessed by researcher), as well as VAS score of general condition and HAQ score (assessed by both patients and researcher, P<0.05). But the differences among groups in improving morning stiffness and the incidence rate of adverse events were in- significant. CONCLUSIONS KXC could relieve symptoms, improve joint functions, physical signs, and laboratory indices of RA patients with less adverse reaction. It was synergistic with MTX.
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An eight-week, multicenter, randomized, double-blind study to evaluate the efficacy and tolerability of fixed-dose amlodipine/benazepril combination in comparison with amlodipine as first-line therapy in chinese patients with mild to moderate hypertension.
Ueng, KC, Lin, LC, Voon, WC, Lin, MC, Liu, YB, Su, HM, Chang, PY, Lin, TH, Chen, WL, Wu, CC, et al
Blood pressure. Supplement. 2008;:24-31
Abstract
AIMS: This study sought to compare the antihypertensive efficacy and tolerability of a fixed-dose combination with amlodipine/benazepril with that of amlodipine monotherapy in Chinese hypertensive subjects. RESULTS This multicenter, double-blind, 8-week study randomized 111 patients to fixed-dose amlodipine besylate/benazepril HCl (2.5/5 mg/day titrated to 5/10 mg/day as needed at week 4 to reach goal blood pressure (BP) <140/90 mmHg) or amlodipine besylate monotherapy (5 mg/day titrated to 10 mg/day as needed). At week 8, patients randomized to combination therapy compared with monotherapy had a comparable BP control rate (56.0% vs. 46.2%; p = 0.32). Fixed-dose combination resulted in similar reductions in sitting systolic (SBP) and diastolic BP (DBP) compared with monotherapy (SBP: -19.3 +/- 12.5 vs. -20.9 +/- 13.3 mmHg; DBP: -9.2 +/- 10.4 vs. -11.3 +/-9.3 mmHg; both p=NS). Safety profiles did not differ between groups, but cough was more common in the combination group (11.0% vs. 0%; p = 0.013). CONCLUSIONS In this group of patients, comparable antihypertensive effects were seen with the fixed-dose combination therapy, compared with amlodipine monotherapy. Both treatments appeared well tolerated in the studied population, but cough was more common in the fixed-dose combination group.