Active clinical trials for "Frailty"

Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting (sarcopenia) and unintentional weight loss. There are currently no approved therapies for frailty. Ghrelin is a hormone produced by the stomach that stimulates appetite centers in the brain. The investigators already know that a single dose of Ghrelin improves food intake immediately after the dose in frail older people. In addition, exercise programs have been shown to improve strength and function in older people. In this study, the investigators are trying to find out if a joint intervention of ghrelin and resistance training will improve walking, balance and leg strength in frail elderly people.

The main purpose of this randomised controlled trial is to study if a Comprehensive Geriatric Assessment (CGA) and follow up for community-dwelling elderly people can improve outcomes such as health and health-related quality of life among both patients and relatives, feeling of safety among both patients and relatives and reduce costs, compared with usual care.

The purpose of this study is to investigate the effects of metformin to prevent frailty in pre-frail non-diabetic elderly. Several outcomes measured in this study are frailty status, quality of life, handgrip strength, gait speed, and serum myostatin levels. We hypothesize that metformin for 16 weeks could prevent frailty in pre-frail elderly.

The primary research question: In critically ill patients with nutrition 'risk factors', what is the effect of providing combined EN/PN to the group prescribed a higher dose (≥2.2 grams/kg/day) of protein/amino acid administration compared to a low group prescribed ≤1.2 gram/kg/day (EN only) on patient's functional recovery as measured by 6-minute walk distance just prior to hospital discharge? The hypothesis: Compared to a control group reflective of usual care prescribing practices and an EN only approach, the administration of a higher dose protein/amino acids using EN and PN to nutritionally high-risk critically ill patients will be associated with improved functional outcome.

Rocha (2017), published a systematic review and meta-analysis highlighting the clinical utility of frailty scales for the prediction of post-operative complications. The results of the review of 15 studies show that, overall, frailty significantly increases the risk for developing adverse outcomes such as, mortality, morbidity and extended length of hospital stay. However, different frailty scales showed different prevalence of frailty even when tested in the same population, which means that future studies are required for a better understanding of frailty tools. Early detection of frailty may provide a window of opportunity for intervention and a key factor to determine clinical outcomes.

Background: Immunosenescence is an aging-dependent phenomenon underlying age dependent deterioration in the function of the immune system, characterized by a decline in B and T cells with a relative increase in natural killer (NK) cells. Aging also promotes chronic inflammation accompanied by increased levels of pro-inflammatory cytokines. Both immunosenescence and inflammation contribute to frailty, which is a geriatric syndrome characterized by age-related deterioration in multiple physiological systems resulting in greater vulnerability to stressors and increased risk of poor outcomes including longer hospital stays, postoperative complications, poor responses to vaccination, functional decline, and death. Although pharmacological interventions could be developed to address immunosenescence, inflammation and frailty, a dietary intervention that does not cause weight or muscle loss may be a preferable option, particularly if it is periodic in nature and it only needs to be adopted for a few weeks per year. Hypothesis: We will test the hypothesis that a newly formulated and relatively high calorie fasting mimicking diet (FMD) to be administered to subjects age 65-80 once a month for 5 days for two to six cycles can partially reverse immunosenescence and inflammation, thus contributing to the reduction of frailty. Aims: This proposal is divided into 2 main tasks: Task 1: We will determine whether FMD cycles in mice: a) prevent frailty syndrome onset and symptoms B) delay or reverse age-related immunosenescence and inflammaging, C) improve the functionality of bone marrow cells, D) enhances the response to flu vaccination. Task 2: A )We will develop a special relatively high calorie FMD medical food for testing in humans, B) We will test the safety and efficacy of the FMD medical food in an aged and frail individuals (65-80 yr) for 2-5 day cycles preceding their annual influenza vaccination. Expected results: In mice, we expect that the FMD diet will reduce the clinical signs of frailty during aging, and in particular increase immune system influenza vaccine response by preventing immunesenescence. We expect that the FMD will reduce phosphorylation of mTOR and of its downstream targets, and induce autophagy and apoptosis in WBCs. These effects are anticipated to remove damaged cells and promote the activation of hematopoietic stem cells and the generation of new WBCs. We also expect that the transient increase in corticosteroids and removal of damage immune cells will be accompanied by a decrease in systemic inflammation. Increased performance on rotarod and other measures of frailty is also anticipated. In humans, we expect that the FMD will be well tolerated by the pre-frail elderly without major adverse events and that it will be possible to achieve high compliance to this diet. We also anticipate that elderly undergoing the FMD protocol followed by 30 days of a normal diet plus supplements will exhibit better functional status and better response to the flu vaccine as compared to patients from the control arm. An improvement in handgrip strength and in lean body mass, as detected by BIA, is also expected, at least in a fraction of the patients from the intervention arm. Impact: Frailty is a geriatric syndrome characterized by age-related deterioration in multiple physiological systems and homeostatic mechanisms, resulting in greater vulnerability to stressors and increased risk of poor outcomes including longer hospital stays, postoperative complications, poor responses to vaccination, functional decline, and death. Thus, the identification of a dietary strategy, potentially to be applied for only 10 days a year but able to rejuvenate the immune profile and function while reducing systemic inflammation could have a major impact on both healthspan and health-related expenses. Because older individuals are often taking multiple drugs, the dietary intervention being investigated here would also reduce the potential toxicity of an additional pharmacological intervention.

Elderly patients residing in nursing homes are particularly at risk of experiencing urgent medical problems needing admission to the Emergency Department (ED). This circumstance contributes to ED overcrowding, increases the risk of ward admission of elderly patients, and puts them at an even higher risk of hospitalization-related adverse events. The study hypothesis is that a complex intervention, delivered directly in nursing homes by hospital physicians in case of urgent medical problems, would contribute to reduce hospitalization of older nursing home residents. The intervention consists in a hospital-based "multidisciplinary mobile unit" (MMU), composed of a hospital specialist and a resident in emergency-urgency medicine who are coordinated by a senior physician serving as "flow manager". The team is active on work days, 8 am to 6 pm, and is activated by general practitioners of nursing homes, in case of urgent medical needs of one of the residents. The activation is made by a phone call to the "flow manager", who triages the clinical needs of the case. The output of the phone consultation may include therapeutic advice provided by phone, immediate on-site visit by the MMU team (specialist and resident), scheduled visit by the MMU team, or direct admission to the hospital unit where MMU is based, avoiding ED visits. The MMU team is provided with a portable ultrasound system, an essential set of drugs and medical devices useful in a urgency setting (central venous lines, nasogastric tubes, rectal tubes, bladder catheters). During on-site visits, the MMU team performs diagnosis, stabilization and therapeutic advice, with the mission of avoiding ED visits and hospital admissions whenever possible. The MMU intervention is already active in two nursing homes, since December 2018. The aim of this prospective, pragmatic, multicenter, quasi-experimental study (sequential design with two cohorts) is to test the effects of the implementation of the MMU care model in terms of reduction of unplanned hospitalization rates (primary outcomes), mortality, health service use and costs (secondary outcomes). Two nursing homes (i.e., the ones who already benefit from the intervention) will serve as study group, and two nursing homes with similar geographical location will serve as control group. All residents of the participating nursing homes will be eligible for study inclusion. The study will last for 18 months, and a number of 338 residents is planned for inclusion.

The POSITIVE platform offers the possibility of unsupervised monitoring of pre-frailty and frailty status in a community setting, to detect the onset of frailty and to assess its evolution. The primary objective of the study is to evaluate whether the POSITIVE system improves frailty in at least 1 point in the Fried's Criteria and 5 points in the FTS-5. This is a multi-centre, non-inferiority, randomized, simple blind and prospective pilot study with a 12-month follow up duration. The study will be carried out in Spain, Sweden and Poland. 150 participants will be randomized into two groups. The control group will receive usual medical care. The intervention group will receive, in addition, the POSITIVE frailty home monitoring and intervention system.

A randomized, controlled, clinical trial on the efficacy of ERAS exercise improve perioperative frailty in patients undergoing elective laparoscopic colorectal surgery Objective to evaluate the efficacy of ERAS exercise improve perioperative frailty in patients undergoing elective laparoscopic colorectal surgery Participants: Patients undergoing elective laparoscopic colorectal surgery over 18 years old. The research intervention was ERAS exercise The study design was a randomized, parallel controlled trial ERAS exercise in perioperative period as the experimental group. No ERAS exercise group was the control group. The sample size was estimated according to the main efficacy index ( the attenuation of frailty after 7 days surgery) of this study. It was assumed that the attenuation of frailty in the ERAS exercise group was better than that of the control group. The parameters were set as test level (alpha) of 0.050 using a two-sided two-sample unequal-variance t-test, β = 0.9, according to the results of previous clinical trials and combined with literature, the population mean difference was 0.6 with standard deviations of 0.8 for the experimental group and 0.8 for the control group. the experimental group: the control group was 1:1, 39 cases in each group, considering the 20% shedding rate, 49 cases in the experimental group and 49 cases in the control group were selected. The experimental group The patients take ERAS exercise from hospitalization to 30 days after operation. The control group The patients do not take ERAS exercise in perioperative period. Efficacy evaluation The primary endpoint of the study was the attenuation of frailty via Frailty Phenotype (FP) between before surgery and 7days, 30 days after surgery. Secondary endpoints included the 6-minute walk test (6MWT),nutritional risk screening (NRS2002), anxious and depressive states, activities of daily living (ADL),postoperative complications and mortality,short-term recovery quality,postoperative pain.

Primary objective: To assess the effects of a modified plant-based Mediterranean diet (vegeterranean diet), circuit resistance training (CRT) and empagliflozin alone or in combination on body composition and physical function in elderly subjects with type 2 diabetes. The rationale for this study is to assess three interventions associated with a negative energy/caloric balance (increased caloric use in exercise, caloric restriction in the vegeterranean diet and caloric wasting by glycosuria with empagliflozin), their interaction and effect on body composition and physical function. Methods and analysis: One hundred and twenty men and women ≥ 65 years of age with type 2 diabetes, and low levels of physical activity will be randomized (1:1:1 manner, gender-stratified) for 10 weeks to one of 3 parallel arms: CRT consisting of 3 home sessions/week; ad-libitum plant-based Mediterranean diet (limited consumption of eggs, dairy and fish, avoidance of red meat and poultry) or empagliflozin 10mg/day. After 10 weeks CRT will be added to the empagliflozin or diet arms for an additional 10 weeks. Allocation concealment and blinding of primary outcome assessors will be implemented. Efficacy will be determined by assessment of lean body mass, body weight, frailty status, sarcopenia, HbA1c and quality of life questionnaires. Safety will be evaluated by routine monitoring of adverse events. This study was approved by the Tel-Aviv Sourasky Medical Center Institutional Review Board