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130 active trials for Frailty

Characterising Frailty Using Magnetic Resonance Imaging

Ageing is associated with the development of various negative conditions, such as frailty. Defined as a decreased ability to combat negative stressors (e.g. injury and illness), frailty is highly prevalent in elderly adults and significantly increases an individual's risk of adverse events such as falls, illness and death. The underlying physical characteristics of frailty are currently incompletely understood, with many previous studies focusing on one tissue (e.g. the brain) in isolation. However, frailty is known to affect many tissues simultaneously, and to further our insight into the biological basis of frailty and how to treat it, we must determine how different organs are affected at the same time. The study will look at the physical characteristics of non-frail and frail elderly females (aged 65 years and over), who are attending geriatric clinics across the Nottingham University Hospitals NHS Trust. We will aim to recruit 51 participants with this cohort broken down into non-frail (n=17), pre-frail (n=17) and frail (n=17) subgroups. Participants will be allocated to these groups based on their Electronic Frailty Index, Clinical Frailty Scale and Fried frailty phenotype scores. All participants will undergo basic muscle function tests (grip strength, leg strength and muscle activity) and questionnaires on their first visit to University of Nottingham laboratories. At a second visit, they will then undergo one Magnetic Resonance Imaging (MRI) scanning session, at the Sir Peter Mansfield Imaging Centre within the University, to gather information about the structure and function of their heart, brain and skeletal muscle. MRI scan protocols will take approximately 45-60 mins. Data gathered from MRI scanning will be compared across non-frail, pre-frail and frail groups to investigate differences across frailty states, with the aim of highlighting the defining physical characteristics of the frail state which may help to develop future treatment interventions to combat the condition. We hypothesise that frail females will present with common physical characteristics, the clustering of which will be indicative of frailty severity. We also hypothesise that certain physical traits present in the frail will not be present in the non-frail.

Start: May 2021

Protocol for Multi-site Evaluation of New Community-based Frailty Programme

Background: Frailty is increasing in prevalence internationally with population ageing. Frailty can be managed or even reversed through community-based interventions delivered by a multi-disciplinary team of professionals, but to varying degrees of effectiveness. However, many of the implementation insights of these care models are contextual, and may not be applicable in different cultural contexts. The Geriatric Service Hub (GSH) is a novel frailty care programme in Singapore, that includes key components of frailty care such as comprehensive geriatric assessments, care coordination and the assembly of a multidisciplinary team. The aim of this study is to gain insights on the factors influencing the implementation approaches adopted by five participating sites, and the effectiveness of the programme. Methods: We will adopt a mixed-methods approach that includes a qualitative evaluation among key stakeholders and participants taking part in the programme, through in depth-interviews and focus group discussions. The main topics covered includes factors that affected the development and implementation of each programme, operations and other contextual factors that influenced implementation outcomes. The quantitative evaluation (1) monitors each programme's care process through quality indicators, (2) a multiple-time point survey study to compare programme participants' pre- and post- outcomes on patient engagement (collaboRATE and 13-item Patient Activation Measure;PAM), healthcare experiences (Consumer Assessment of Healthcare Providers and System Clinician and Group Survey Version 3.0; CG-CAHPS), health status and quality of life (Barthel Index of Activities of Daily Living, fall counts, the EuroQol questionnaire and the Control, Autonomy, Self-realization and Pleasure scale; CASP-19), impact on caregivers (Zarit Burden Interview) and societal costs (Client Service Receipt Inventory). (3) A retrospective cohort design to assess healthcare and cost utilisation between participants of the programme and a propensity score matched comparator group. Discussion: The GSH sites share a common goal to increasing accessibility of essential services to frail older adults, and providing comprehensive care. The results of this evaluation study will provide valuable evidence to the impact and effectiveness of the GSH, and inform to the design of similar programmes targeting frail older adults.

Start: April 2019

Physical Function of Older Citizens During Municipality-based Rehabilitation

When choosing outcomes to assess rehabilitation's effect or progress, it is essential to consider the constructs being measured and their value to the patient and the psychometric properties. Choosing an outcome that reflects all aspects of International Classification levels of Functioning, Disability and Health (ICF) is challenging, especially in heterogeneous groups. However, it is important to know the psychometric properties as this gives important knowledge on how to interpret results and, consequently, how this can inform the patient's care. The Short Musculoskeletal Function Assessment (SMFA) questionnaire can reflect differences in patients' functional status with a broad range of disorders, like for elderly citizens undergoing municipality-based rehabilitation. Nevertheless, since there is no golden standard to measure rehabilitation outcomes, construct validity needs to be established to investigate how scores of SMFA can be related to measures on all levels of ICF. Therefore, this study has three main objectives: To investigate how scores of the SMFA questionnaire are related to measures on different ICF levels To describe the characteristics of older citizens starting municipality-based rehabilitation on all ICF levels To investigate predictor variables of upper- and lower extremity strength

Start: January 2021

Qigong to Improve Frailty Among Older Cancer Survivors

The objective of the study is to examine the effects of a 16-week Baduanjin qigong intervention on frailty, physical performance, psychological well-being, and health-related quality of life (HRQoL) among post-treatment older cancer survivors. This will be a randomized controlled, assessor-blind trial conforming to the CONSORT guidelines. A total of 226 cancer survivors aged over 65 who have completed curative treatment and screened as pre-frail or frail will be recruited and randomized into intervention and control groups. It is expected that upon intervention completion, the intervention group will demonstrate greater reversed frailty status, more improvements in physical performance, better psychological well-being, and enhanced HRQoL compared to the control group. Study instruments will be Fried Phenotype Criteria, Edmonton Frail Scale, Short Physical Performance Battery, Geriatric Depression Scale, European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire, and a background questionnaire. The intervention comprises of 1-hour qigong group training twice a week for 8 weeks, then 1-hour weekly follow-up group practice for 8 weeks and self-practice. The control group participants will attend light flexibility exercise group sessions at the same duration and frequency as the intervention group. Intention-to-treat analysis will be performed.

Start: February 2021

Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults

This is study to investigate the effects of a brief mindfulness-based program for frail older adults caregivers.

Start: May 2021

A Study of Wrist Worn Accelerometers in End-Stage Renal Disease

The kidneys are important at getting rid of toxins and excess water from the body. If they fail, then toxins and excess water builds up within the body. Kidney failure is treated by either giving patients a new kidney (a transplant) or by removing the toxins and fluid from the body by the process of dialysis. The investigators' aim is to personalise the care given to patients with kidney failure, and as such, they have started measuring the fitness of patients with kidney failure, who either already require dialysis or may need dialysis in the near future. This is currently done in a number of ways including measuring how strong their grip is, assessing their walking speed and asking questions about how difficult they find certain activities. In the future, the investigators think that this will allow targeted treatments to help improve their fitness and potentially identify any problems earlier. Current approaches to measuring activity and fitness have limitations and in particular may over- or underestimate the level of the physical activity. To over come these limitations, participants will be asked to wear an activity tracker (called an accelerometer) on for a week. Readings from the accelerometer will be compared against the other markers of fitness and activity to see if they are comparable. It will also be noted whether patients are prepared to wear the device for 7 days (compliance).

Start: July 2021

Nitrites, Skeletal Muscle Mitochondrial Bioenergetics, and Physical Activity in Old Age

This 2-site randomized double blinded controlled trial is to confirm and more definitively clarify the impact of a 12-week course of nitrite versus placebo on mitochondrial bioenergetics in older sedentary adults. This investigator will take an integrative physiology approach to determine the effect of nitrite therapy on a comprehensive assessment of mitochondrial energetics, skeletal muscle vascular function, and whole body physical function (cardiorespiratory function, exercise endurance, strength, balance, and physical activity) and fatigability.

Start: April 2021

Identifying Modifiable PAtient Centered Therapeutics (IMPACT) Frailty

Frailty, the decline in physical and cognitive reserves leading to vulnerability to stressors is increasingly being recognized as a public health concern. Although multiple measures exist that can identify frail patients, very little is known about how or when to intervene. Sarcopenia, or the degree of muscle wasting, is closely correlated to frailty and patient outcomes. This is a prospective cohort study of critically ill patients to identify modifiable risk factors of sarcopenia, as potential targets to reduce frailty.

Start: June 2021

Effect of Baduanjin on Functional Performance in Pre-Frail/Frail Older Adults

The aim for this study is to investigate the effectiveness of a 16-week realistic community-delivered Baduanjin training program compared to a waitlist control intervention, in improving functional outcomes among pre-frail and frail older adults in Singapore. It is hypothesized that participants that receive 16-week of BDJ training will have significant improvement in physical function (including balance, muscle strength, and endurance); alleviate exhaustion; reduce risk of falling and fear of falling; potentially reverse frailty; reduce depression; and improve quality of life, potentially with greater improvements in area(s) for individuals with lower baseline measures. Whereas, participants in the waitlist control group, will have insignificant changes to their baseline measures.

Start: April 2021

Correlation of Preoperative Olfactory Identification Function With Frailty and Postoperative Complications and Mortality

The aim of this research project is to evaluate whether olfactory identification impairment is a reliable predictor of preoperative frailty and of postoperative complications and mortality in a population of older patients scheduled for elective surgery. The investigators will measure preoperative olfactory identification function and evaluate whether olfactory impairment predicts frailty, using the Edmonton Frail Scale and handgrip strength. The investigators will analyze whether preoperative olfactory impairment predicts postoperative complications and mortality.

Start: July 2020

PRecisiOn MEdicine to Target Frailty of Endocrine-metabolic Origin

This is a multicenter, observational, retrospective and prospective study for the evaluation of precision medicine to target frailty of endocrine-metabolic origin, with a genetic study.

Start: August 2020

ReVital-CORE Program

Pilot feasibility study of the ReVital Chemotherapy Online Resiliency Evaluation (CORE) program. As part of standard of care, patients starting a new chemotherapy regimen are referred to complete a pre-chemotherapy cancer rehabilitation evaluation (i.e., prehab) and invited to enroll in the ReVital-CORE program study. Once enrolled in ReVital-CORE, participants will complete a monthly online evaluation for 1 year. If frailty (or pre-frailty) is detected on any survey, physical or occupational therapy will be initiated for standard of care rehabilitation evaluation and treatment.

Start: January 2021

Cognitive Frailty in Older Adults: The Role of Technology in Physical Activity Enhancement

This study intends to determine if smart watches and mobile phone application prompts can complement physical activity as a preventive intervention by motivating participants to exercise, so as to improve their physical and cognitive outcomes. The investigators hypothesize that technology will help increase engagement in physical activity for the intervention group relative to the control group and subsequently improve cognitive and physical outcomes.

Start: December 2020

Correlation of Preoperative Global Olfactory Function With Frailty, Perioperative Neurocognitive Disorders and Mortality

The aims of this research project are to evaluate whether global olfactory impairment is a reliable indicator of preoperative frailty and cognitive impairment, and whether it may predict postoperative neurocognitive disorders, morbidity and mortality in a population of older patients scheduled for elective intermediate- to high-risk elective surgery. We will measure preoperative global olfactory function (threshold, discrimination, identification) and evaluate whether olfactory impairment predicts preoperative frailty (using the Edmonton Frail Scale, the Clinical Frailty Scale and handgrip strength) and postoperative complications and mortality. We will address the question whether preoperative olfactory impairment may be associated with a preoperative cognitive impairment (through a neuropsychological test battery) and whether it may predict a decrease in postoperative neurocognitive function.

Start: March 2021

Postoperative Cognitive Dysfunction in Elderly Urologic Oncology Patients (POCD)

Postoperative cognitive changes are more common in elderly patients, which can result in poor quality of life, loss of workforce, disability, early retirement, physical-social dependence, increased health care cost and premature mortality. Postoperative cognitive complications are also quite common in extensive oncological surgeries. In this study, our aim is to evaluate the relationship between the development of postoperative cognitive dysfunction (POCD) in geriatric urologic oncology patients with brain injury and inflammatory markers [S100 ?, neuron specific enolase (NSE), interleukin 6 (IL-6) and high mobility group box-1 (HMGB-1 protein)].

Start: April 2020

LIFT Intervention in Liver Transplant Candidates

Frailty is a significant problem in patients undergoing liver transplant and is associated with poor outcomes and survival. Hence, optimizing physical fitness and counteracting frailty is important. However, many interventions are very resource intensive and therefore not feasible. In this study, the investigators aim to test the effectiveness of a newly designed intervention to improve frailty in liver transplant candidates. The "LIver FrailTy" intervention (LIFT) will consist of an evaluation by a physical therapist, an individualized home exercise prescription (HEP), exercise tracking using a smart phone application, daily text reminders to exercise and recurrent telephone check-ins. The investigators also aim to perform "Realistic Effort Action Planning" (REAP), which is a form of personality-informed motivational interviewing, in a subset of patients to determine if this enhances the LIFT intervention.

Start: October 2020

Comparison of Three Frailty Screening Tools

The financial health care and social impact of the frailty of the elderly is an important issue for preventive health care in various countries around the world. The Taiwan government launched the long-term care 10-year plan version 2.0 in 2017 and expanded service target with older people with frailty as a service need. There is no consensus on the definition of frailty. However, there are many existing frailty screening instruments. It is very important to choose accurate and simple and rapid tools for screening to reduce the extra medical costs caused by negative outcomes of frailty. The primary purpose of this study is to understand the transition changes of the elderly in the community during the six months of frail state (robust, pre-frail, frail), and examine the validity of the frailty, physical function (handgrip strength, walking speed) to predict negative outcomes (falls, institutionalization/hospitalization), and will be compared with the results of three frailty screening tools. The secondary purpose is to compare the feasibility (screening time, screening completion rate, equipment and space) of the three tools for the frailty screening of the elderly in the community.

Start: March 2021

Reducing Frailty for Older Cancer Survivors Using Supplements

The purpose of the study is to to obtain preliminary data on the effects of twelve weeks oral supplementation of Epigallocatechin-3-gallate (EGCG) on frailty and inflammation in older survivors of colon cancer

Start: March 2021

Comprehensive Geriatric Assessment for Frail Older People With Chronic Kidney Disease - The GOAL Trial

The GOAL trial addresses patient-prioritised research topics and outcomes and will be conducted, disseminated and implemented in partnership with patients and their caregivers. This will be the first study, internationally, to evaluate the clinical and cost effectiveness of Comprehensive Geriatric Assessment (CGA), a highly promising intervention for improving patient-important health outcomes in frail older people with CKD.

Start: March 2021

Diet and Exercise Plus Metformin to Treat Frailty in Obese Seniors

The continuing increase in prevalence of obesity in older adults including many older Veterans has become a major health concern. The clinical trial will test the central hypothesis that a multicomponent intervention consisting of lifestyle therapy (diet-induced weight loss and exercise training) plus metformin will be the most effective strategy for reversing sarcopenic obesity and frailty in older Veterans with obesity.

Start: March 2021