Multifactorial interventions to prevent falls in older adults

BACKGROUND: Falls are one of the most common syndromes in old age. An estimated 646,000 deaths from falls occur each year worldwide. Moreover, most fatal falls occur in people over 65 years of age. Most falls are the result of the interaction of several factors. AIMS: To examine the long-term effectiveness of multifactorial interventions in preventing falls in elderly and senile patients. MATERIALS AND METHODS: A sample of patients territorially attached to the Family Medicine Center of the North-Western State Medical University named after I.I. Mechnikov was established four years ago. Individual fall prevention programs were developed for all study participants (n = 260) because they had different falls risk factors. Patient follow-up was continued for 12 months. The results of the multifactorial intervention were evaluated after 12 months and after 3 years, 2 times in total, the last study in a random subsample of patients (n = 84). Aging asthenia screening, questionnaires, assessment of emotional status, and presence of sleep disturbances were performed to assess the risk of falls. The effectiveness of multifactorial interventions was assessed based on repeated assessment of risk factors for falls. RESULTS: Participants with a history of falls were significantly more likely to have symptoms of depression, anxiety, symptoms of frailty, visual and hearing impairment (p 0.05). On average, each participant in the group with falls had 6.1 2.1 risk factors for falls and 3.8 2.3 in the group without falls (p = 0.000). During the follow-up period after the interventions, the incidence of falls decreased 9-fold after one year (from 28.5% to 3.1%) and then increased to 23.8%. All patients who fell after the multifactorial intervention had a history of cognitive impairment and falls. In addition, in the group of patients with falls, fall risk factors such as low levels of physical activity, hearing impairment, and the presence of a traumatic environment at home were not eliminated. As a result of the interventions, fear of falls disappeared in 9 patients, 95% CI (2.35-65.89), p = 0.039. CONCLUSIONS: The study demonstrated a decrease in the effectiveness of multifactorial interventions to prevent falls at three years. A less persistent effect was seen in patients with a history of falls. A history of falls, symptoms of frailty, complaints of fear of falls, sleep disturbances, and anxiety symptoms were factors that increased the risk of falls. Individualized fall prevention programs resulted in decreased fear of falls.

Efficacy and durability of multifactorial intervention on mortality and MACEs: a randomized clinical trial in type-2 diabetic kidney disease

Background Multiple modifiable risk factors for late complications in patients with diabetic kidney disease (DKD), including hyperglycemia, hypertension and dyslipidemia, increase the risk of a poor outcome. DKD is associated with a very high cardiovascular risk, which requires simultaneous treatment of these risk factors by implementing an intensified multifactorial treatment approach. However, the efficacy of a multifactorial intervention on major fatal/non-fatal cardiovascular events (MACEs) in DKD patients has been poorly investigated. Methods Nephropathy in Diabetes type 2 (NID-2) study is a multicentre, cluster-randomized, open-label clinical trial enrolling 395 DKD patients with albuminuria, diabetic retinopathy (DR) and negative history of CV events in 14 Italian diabetology clinics. Centres were randomly assigned to either Standard-of-Care (SoC) (n = 188) or multifactorial intensive therapy (MT, n = 207) of main cardiovascular risk factors (blood pressure < 130/80 mmHg, glycated haemoglobin < 7%, LDL, HDL and total cholesterol < 100 mg/dL, > 40/50 mg/dL for men/women and < 175 mg/dL, respectively). Primary endpoint was MACEs occurrence by end of follow-up phase. Secondary endpoints included single components of primary endpoint and all-cause death. Results At the end of intervention period (median 3.84 and 3.40 years in MT and SoC group, respectively), targets achievement was significantly higher in MT. During 13.0 years (IQR 12.4–13.3) of follow-up, 262 MACEs were recorded (116 in MT vs. 146 in SoC). The adjusted Cox shared-frailty model demonstrated 53% lower risk of MACEs in MT arm (adjusted HR 0.47, 95%CI 0.30–0.74, P = 0.001). Similarly, all-cause death risk was 47% lower (adjusted HR 0.53, 95%CI 0.29–0.93, P = 0.027). Conclusion MT induces a remarkable benefit on the risk of MACEs and mortality in high-risk DKD patients. Clinical Trial Registration ClinicalTrials.gov number, NCT00535925. https://clinicaltrials.gov/ct2/show/NCT00535925

Effect of Training-Detraining Phases of Multicomponent Exercises and BCAA Supplementation on Inflammatory Markers and Albumin Levels in Frail Older Persons

Nowadays, it is accepted that the regular practice of exercise and branched-chain amino acids supplementation (BCAAs) can benefit the immune responses in older persons, prevent the occurrence of physical frailty (PF), cognitive decline, and aging-related comorbidities. However, the impact of their combination (as non-pharmacological interventions) in albumin and the inflammatory markers is not fully understood. Therefore, we investigated the effect of a 40-week multifactorial intervention [MIP, multicomponent exercise (ME) associated or not with BCAAs] on plasma levels of inflammatory markers and albumin in frail older persons (≥75 years old) living at residential care homes (RCH). This study consisted of a prospective, naturalistic, controlled clinical trial with four arms of multifactorial and experimental (interventions-wahshout-interventions) design. The intervention groups were ME + BCAAs (n = 8), ME (n = 7), BCAAs (n = 7), and control group (n = 13). Lower limb muscle-strength, cognitive profile, and PF tests were concomitantly evaluated with plasma levels of albumin, anti- and pro-inflammatory cytokines [Interleukin-10 (IL-10) and Tumor Necrosis Factor-alpha (TNF-α) respectively], TNF-α/IL-10 ratio, and myeloperoxidase (MPO) activity at four different time-points: Baseline (T1), after 16 weeks of multifactorial intervention (T2), then after a subsequent 8 weeks washout period (T3) and finally, after an additional 16 weeks of multifactorial intervention (T4). Improvement of cognitive profile and muscle strength-related albumin levels, as well as reduction in the TNF-α levels were found particularly in ME plus BCAAs group. No significant variations were observed over time for TNF-α/IL-10 ratio or MPO activity. Overall, the study showed that MIP triggered slight alterations in the inflammatory and physical function of the frail older participants, which could provide independence and higher quality of life for this population.

Effect of a Multifactorial Intervention on Fracture in Patients With Type 2 Diabetes: Subanalysis of the J-DOIT3 Study

Aims To evaluate the effects of an intensified multifactorial intervention and patient characteristics on the incidence of fractures comorbid with type 2 diabetes. Methods Fracture events were identified and analyzed among adverse events reported in the J-DOIT3 study, a multicenter, open-label, randomized, parallel-group trial that was conducted in Japan, in which patients with type 2 diabetes were randomly assigned to receive conventional therapy for glucose, blood pressure, and lipids (targets: HbA1c &lt; 6.9%, blood pressure &lt;130/80 mm Hg, LDL-cholesterol &lt;120mg/dL) or intensive therapy (HbA1c &lt; 6.2%, blood pressure &lt;120/75 mm Hg, LDL-cholesterol &lt;80mg/dL) (ClinicalTrials.gov registration no. NCT00300976). Results The cumulative incidence of fractures did not differ between those receiving conventional therapy and those receiving intensive therapy (hazard ratio (HR) 1.15; 95% CI, 0.91-1.47; P = 0.241). Among the potential risk factors, only history of smoking at baseline was significantly associated with the incidence of fractures in men (HR 1.96; 95% CI, 1.04-3.07; P = 0.038). In contrast, the incidence of fractures in women was associated with the FRAX score [%/10 years] at baseline (HR 1.04; 95% CI, 1.02-1.07; P &lt; 0.001) and administration of pioglitazone at 1 year after randomization (HR 1.59; 95% CI, 1.06-2.38; P = 0.025). Conclusions Intensified multifactorial intervention may be implemented without increasing the fracture risk in patients with type 2 diabetes. The fracture risk is elevated in those with a history of smoking in men, whereas it is predicted by the FRAX score and is independently elevated with administration of pioglitazone in women.

Multifactorial intervention and effect on morbidity, preventive medication and mortality in patients with type 2 diabetes within cardiac rehabilitation

Background Although studies have reported beneficial impact of cardiac rehabili-ta-tion in the overall population, knowledge from clinical randomized trials of the effect of cardiac rehabilitation in patients with type 2 diabetes is still sparse. Purpose In the randomized DANSUK trial, we aimed to evaluate the short- and long-term effect on cardiovascular disease, hospital readmissions, mortality and use of preventive medication in patients with type 2 diabetes referred to comprehensive cardiac rehabilitation by comparing an intensified, targeted, multifactorial intervention with standard of care. Methods From 2000 to 2004 a total of 151 patients with type 2 diabetes and with ischemic heart disease (53%), heart failure (18%), or high-risk patients with at least three risk factors for ischemic heart disease (29%) were included in the DANSUK trial. The patients were allocated to standard of care (N=76) following current guidelines or comprehensive cardiac rehabilitation during a twelve weeks program with a stepwise implementation of behaviour modification and preventive medication to reach treatment goals (N=75). Clinical outcomes were compared after three and fourteen years of follow-up using national registries. Primary composite outcome measure included overall mortality, myocardial infarction or acute first-time readmission. Results Mean age was 66 years and more than one third of the population were women. After three years of follow-up, no difference in primary outcome was obtained (HR: 0,87; 95% CI: 0,58–1,32), but when hospitalized within the first three years, mean length of stay was significantly reduced by 25% in patients who had attended comprehensive cardiac rehabilitation compared to standard of care (5,8 vs. 7,7 days; p&lt;0.04). After fourteen years of follow-up there was still no difference in the combined endpoint between the two treatment groups. Conclusions Although the DANSUK trial earlier has demonstrated reductions in several risk factors and in the use of preventive medication in patients with abnormal glucose metabolism attending comprehensive cardiac rehabilitation compared to standard of care, these effects did not translate into the primary composite endpoint after three and fourteen years of follow-up in patients with known type 2 diabetes at enrolment. Nevertheless, there was a significant reduction in length of stay when admitted to hospital in the cardiac rehabilitation group compared to standard of care within the first three years of follow-up. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): The Danish Heart Foundation