Frail Elderly Syndrome

14

Review clinical trials related to Frail Elderly Syndrome. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

The Impact of Geriatric Assessment on the Treatment Plan of Elderly Patients With T2DM

Introduction: With the aging of the world population and the increasing incidence of type 2 diabetes mellitus (T2DM) with age, the number of elderly individuals living with diabetes has been considerably rising. It is known that uncontrolled T2DM negatively impacts various health outcomes, including geriatric outcomes such as sarcopenia, frailty, immobility, incontinence, and infections. Current medical literature fails to establish appropriate glycemic targets for different elderly profiles. Although guidelines emphasize the need to individualize targets, there is no concise tool to identify which individuals benefit from each therapeutic approach. Data suggest that frailty is the best predictor of negative outcomes in elderly patients living with T2DM. The Clinical Frailty Scale (CFS) and the 10-minute Targeted Geriatric Assessment (TaGA-10) are validated tools for prognosis in elderly patients and for identifying frail elderly individuals. Methods: Randomized controlled trial. Elderly individuals diagnosed with T2DM at a tertiary care outpatient clinic will be included. All enrolled patients will undergo geriatric assessment using CFS, TaGA-10, and Charlson Comorbidity Index. Patients will be randomized into usual care and intervention groups, and the intervention involves providing the geriatric assessment to the care team to support their decisions. The adequacy of the therapeutic approach will be measured in one week by reviewing the consult record or interviewing the physician. The clinical impact on the frequency of hypoglycemia, falls, infections, hospitalizations, and mortality will be evaluated at 3 and 6 months by telephone interviews. Discussion: Current guidelines recommend using age, comorbidities, cognitive, and functional status to individualize therapeutic targets in elderly patients with T2DM; however, it is possible that these variables alone may not be sufficient to classify all elderly individuals in their complexity adequately. A tool with such power and easy to use in clinical practice is necessary.

Participants needed: 220
Trial details
Age: 60+Biological sex: AllType: InterventionalSponsor: Hospital de Clinicas de Porto AlegreUpdated: May 29, 2026Locations: 1
Eligibility criteria

Age 60 years or older [+3]

Lack of consent for research participation from the patient or the physician [+1]

Status: Not yet recruiting

High-technology TeleRehabilitation for the Treatment of the FRAgile Patient

The aim of this randomized controlled clinical trial is to evaluate the efficacy of an 8-week sensorimotor and cognitive telerehabilitation program in frail and pre-frail older adults with stable chronic heart failure. The study will compare a synchronous telerehabilitation intervention with a caregiver-supervised home exercise program. The primary question is whether telerehabilitation improves functional capacity, measured by change in peak oxygen uptake (VO₂peak) on cardiopulmonary exercise testing, more than the control intervention. A key secondary question is whether telerehabilitation improves frailty status, measured by the Italian Frailty Index (IFI), compared with the control group. Secondary outcomes include quality of life, physical performance, cognitive function, treatment adherence, caregiver burden and stress, and selected biomarkers related to heart failure and frailty. Participants will undergo baseline and follow-up clinical, functional, cognitive, and laboratory assessments and will be followed for up to 24 weeks.

Participants needed: 70
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: University of SalernoUpdated: May 7, 2026
Eligibility criteria

Age 65 years or older. [+4]

Age younger than 65 years. [+6]

Status: Recruiting

Assessing a New Tool to Assess Frailty in Frail Hospitalized Elderly

The major purpose of this study is to establish the use of daily step counts as inexpensive, easy to measure marker for frailty and sarcopenia in an inpatient population of older adults.

Participants needed: 120
Trial details
Age: 65+Biological sex: AllType: ObservationalSponsor: University of British ColumbiaUpdated: May 1, 2026Locations: 1
Eligibility criteria

be 65 years of age or older [+1]

be less than 65 years of age [+2]

Status: Not yet recruiting

The Importance of Anesthesia Method in Fragile Patients

The aim of this study is to comparatively evaluate the effects of different anaesthesia methods (spinal anaesthesia and general anaesthesia) administered to frail elderly patients scheduled for transurethral surgery (e.g. TUR-Prostate or TUR-Bladder) on postoperative morbidity and mortality rates.

Participants needed: 180
Trial details
Age: 65+Biological sex: AllType: ObservationalSponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUpdated: Sep 25, 2025
Eligibility criteria

Elderly patients aged 65 and over [+2]

Non-elective emergency surgeries [+4]

Status: Not yet recruiting

Effect of a Combined Exercise and Anti-Inflammatory Nutritional Intervention in Frail Older Adults

The goal of this clinical trial is to evaluate whether a combined intervention of therapeutic exercise and anti-inflammatory nutritional supplementation improves physical performance and reduces systemic inflammation in frail, malnourished older adults. The main questions it aims to answer are: Does the addition of an anti-inflammatory nutritional supplement (Alisenoc™) to a multicomponent exercise program (Vivifrail) lead to greater improvements in physical performance compared to standard exercise and conventional nutritional support? Does the combined intervention reduce levels of inflammatory biomarkers (e.g., IL-6, TNF-α, IL-8, GDF-15) in this population? Are there measurable changes in body composition (e.g., muscle mass, fat mass, bone health) following the intervention? Does the intervention impact clinical outcomes such as hospital readmissions, functional independence, or mortality over the following 12 months? Researchers will compare two groups: One group receiving the Vivifrail exercise program plus a daily dose of the anti-inflammatory nutritional supplement Alisenoc™. Another group receiving the same Vivifrail program plus an isocaloric, protein-equivalent conventional supplement. Participants will: Be aged 75 years or older and identified as frail and malnourished according to Fried and GLIM criteria. Undergo baseline evaluation including functional performance (SPPB), body composition via bioimpedance analysis, and blood sample collection for inflammatory biomarkers. Be randomly assigned to one of the two intervention groups. Follow a 12-week home-based multicomponent exercise program guided by educational materials and supervised remotely. Consume the assigned oral nutritional supplement daily for the same 12-week period. Return for outcome assessments at 12 weeks, and again at 6 and 12 months for long-term follow-up. All study procedures will take place at the Hospital Universitario de Navarra (HUN), Spain. Participants will be recruited from outpatient geriatrics and nutrition clinics and assessed at a dedicated research unit with nursing support. The intervention is designed to be feasible, scalable, and representative of real-world multidisciplinary care in older populations with high vulnerability. The study aims to provide evidence for an integrative, personalized approach to reversing frailty through combined physical and nutritional strategies targeting the biological basis of inflammaging.

Participants needed: 158
Trial details
Age: 75+Biological sex: AllType: InterventionalSponsor: Fundacion Miguel ServetUpdated: Sep 19, 2025
Eligibility criteria

Patient aged ≥ 75 years. [+5]

Presence of type 1 or type 2 diabetes mellitus with poor metabolic control (HbA1... [+5]

Status: Recruiting

Patient's Database: Prepare for Your Surgery Program

Frailty is a multidimensional syndrome that predominantly affects older people and people with long-term treatments such as cancer and chronic pain. This results in an increased risk of disability, reduced resistance and greater vulnerability to stressors. These factors culminate in worse postoperative outcomes, including higher rates of complications and mortality. With the current demographic shift towards an aging population in Latin America and Chile, the prevalence of frailty among surgical patients is increasing. Despite the clear association between frailty and adverse postoperative effects, in Chile there are few centers that routinely perform objective preoperative frailty assessment before to surgery. This is due to logistical challenges, the need for specialized training, and assessment tools. As a result, frailty remains an underestimated syndrome in the perioperative setting. Various interventions have been proposed to improve the care of fragile surgical patients. Prehabilitation, a multidisciplinary program designed to prepare patients for surgery and improve their resilience to surgical stress, has emerged as a promising intervention. Recent studies indicate that prehabilitation may lead to shorter hospital length of stay (LOS) and fewer complications. Recognizing the vital role that frailty plays in surgical outcomes and the paucity of research on prehabilitation, a prehabilitation or timely presurgical conditioning program (Prepare for Your Surgery Program) has been implemented at our center. This proposal seeks to optimize the patient before a surgical intervention in order to reduce frailty and complications, thus improving recovery and medium-term results. The program consists of interventions 4 to 6 weeks before surgery focused on: nursing assessment, screening and follow-up, geriatric and/or internal medicine assessment and intervention, physiotherapy assessment and intervention, nutrition assessment and intervention, psychological assessment and intervention, and preoperative anesthesiology intervention. For this purpose, it has been proposed to create a prospective database of patients from the Prepare for Your Surgery Program, who undergo elective surgery at Hospital Clinico Red Salud UC-Christus.

Participants needed: 120
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Pontificia Universidad Catolica de ChileUpdated: Jun 10, 2025Locations: 2Duration: 3 Months
Eligibility criteria

Patients referred to the Prepare for Your Surgery program [+2]

Patients who will not undergo elective surgery at Hospital Clínico Red de Salud... [+2]

Status: Recruiting

Non-pharmacological Prevention of POD in Frailty Elderly Undergoing Elective Surgery Applied by Nursing Teams

The increase in the population over 60 years of age who could receive surgery due to changes in life expectancy and advances in surgical and anesthetic techniques. Likewise, elderly people (EP) may have a higher risk of postoperative morbidity and mortality compared to young people, with frailty being one of the risk factors that increases adverse outcomes in this period and increases the probability of developing syndromes such as postoperative delirium (POD). Assessment of frailty in EP prior to surgery is not routine, so it is unknown how many frail and/or pre-frail EP undergo surgery in health care systems. There is an association between being frail and developing greater delirium and/or postoperative cognitive deficit, which in summary translates into an increase in perioperative morbidity and mortality. For the prevention of POD, there are pharmacological and non-pharmacological measures that seek to promote orientation with respect to their environment and make it as familiar as possible, stimulate early aspects of memory and thinking skills, as well as promote sleep using environmental hygiene measures. In Chile, protocols of non-pharmacological measures have been proposed by occupational therapy teams, which have had positive results in reducing POD in frail elderly patients. These measures are temporal-spatial reorientation, physical mobilization, correction of sensory deficits, environmental management, sleep protocol, and reduction of anticholinergic drugs with statistically significant results in the reduction of POD. In accordance with the above, the objective of this study is to evaluate the impact of non-pharmacological measures applied by the nursing team in reducing the incidence of POD during the post-surgical period in fragile and pre-fragile EP undergoing elective non-cardiac surgeries. It is expected that in the end, frail and pre-frail EP who receive non-pharmacological interventions by the nursing team will present a lower incidence of POD at 24 hours compared to those who receive traditional care.

Participants needed: 400
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: Pontificia Universidad Catolica de ChileUpdated: Jun 10, 2025Locations: 1
Eligibility criteria

Patients older than 65 years [+3]

Neurosurgical patients [+3]

Status: Recruiting

The NADage Study: Nicotinamide Riboside Replenishment Therapy Against Functional Decline in Aging

This clinical study, designed as a double-blind, randomized, placebo-controlled trial, aims to investigate the potential of nicotinamide riboside (NR) to decelerate functional decline in the elderly frail population. In animal studies, NR, which is converted to nicotinamide adenine dinucleotide (NAD), has shown potential as a neuroprotective agent, with indications of protection against amyotrophic lateral sclerosis (ALS), Alzheimer's dementia, and Parkinson's disease. Furthermore, aging is commonly associated with decreased tissue NAD levels, a phenomenon linked to premature aging and a spectrum of age-related disorders, including cardiovascular diseases and cancers. Existing preclinical and clinical research highlights the promise of NAD replenishment through enhanced DNA repair, sirtuin activity, and improved mitochondrial function. The research center has conducted two phase II clinical trials on NR for Parkinson's disease (NAD-PARK and NR-SAFE), administering up to 3000 mg of NR daily. These trials have shown promising results, indicating NR's potential as a treatment that may alter the course of the disease and possibly as neuroprotective treatment in Parkinson's disease. The NAD age trial primarily aims to determine: * The efficacy of NAD therapy in improving clinical symptoms of frailty, evaluated through standardized physical and cognitive function tests. * The safety of administering 2000 mg NR daily in an elderly frail population. The study will include 100 individuals, classified as frail based on the Fried Frailty Phenotype. Participants will be randomly assigned to receive either 2000 mg of NR daily or a placebo. Over a 52-week period, participants will undergo: * Clinical evaluations, including actigraphy and questionnaires. * Cognitive assessments. * Bio sampling. * Magnetic resonance imaging (MRI). * Positron emission tomography (FDG-PET) scanning. The outcomes of this study could potentially demonstrate that NR effectively reduces signs of frailty, offering considerable advantages to the individuals affected, their families, and society as a whole.

Participants needed: 100
Trial details
Phase: Phase 2Age: 75+Biological sex: AllType: InterventionalSponsor: Haukeland University HospitalUpdated: Jan 20, 2025Locations: 2
Eligibility criteria

Participant must understand the nature of the study and be able to provide writt... [+3]

Inability to provide informed consent. [+12]

Status: Recruiting

Multimodal Prehabilitation for Surgery in the Elderly: a Randomised, Prospective, Multicenter, Multidisciplinary Trial

This multicentric, randomised controlled trial is to the investigators knowledge the first implementation of a multimodal, multidisciplinary prehabilitation approach using knowledge from different specialties to lower complications and to increase cost effectiveness after major surgery in elderly, frail patients.

Participants needed: 466
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: Insel Gruppe AG, University Hospital BernUpdated: Nov 1, 2024Locations: 1
Eligibility criteria

Written informed consent [+4]

Paralysis or patients with mobility problems (who are unable to exercise), [+4]

Status: Not yet recruiting

Effectiveness of a Socio-Community Health Intervention on Pre-Frailty in Older Adults

The objective of this study is: To evaluate the effectiveness of a health intervention with a socio-community approach on frailty in older adults with pre-frailty. Specific Objectives: To characterize the study population according to sociodemographic and clinical variables. To evaluate the effect of the intervention on the functionality domain at 3 and 6 months. To evaluate the effect of the intervention on the cognitive-emotional domain at 3 and 6 months. To evaluate the effect of the intervention on the socio-community domain at 3 and 6 months. To evaluate the effect of the intervention on frailty in older adults. To determine the proportion of participants hospitalized during the study period. To determine the proportion of participants who visited the emergency room during the study period. To determine the proportion of participants in long-term care facilities. To determine the proportion of adverse events associated with the intervention. Study Hypothesis The mean frailty score pre-intervention is equal to the mean frailty score post-intervention. The mean frailty score pre-intervention is different from the mean frailty score post-intervention.

Participants needed: 160
Trial details
Age: 60+Biological sex: AllType: InterventionalSponsor: Keralty SAS. ColombiaUpdated: Oct 29, 2024
Eligibility criteria

Individuals ≥ 60 years old classified as pre-frail in the last 3 months and docu... [+2]

Individuals receiving care at community-focused medical centers. [+8]

Status: Recruiting

Antibiotic Dosing in Geriatric Patients At the Emergency Department

In this pilot study, we will investigate whether - with the current dosing regimens, used in the Ghent University Hospital - pharmacodynamic targets regarding beta-lactam antibiotics (more specific Amoxicilline-Clavulanate, Piperacillin-Tazobactam and Temocillin) are attained in frail patients admitted to the geriatric department.

Participants needed: 180
Trial details
Age: 75+Biological sex: AllType: ObservationalSponsor: University Hospital, GhentUpdated: Sep 19, 2024Locations: 1Duration: 2 Weeks
Eligibility criteria

Patients presenting at the emergency department and later on admitted to the ger... [+4]

Admission to other units than the geriatric department incl. the ICU. [+3]

Status: Recruiting

INTEgRated Health CARE for Patients With Frailty and Heart Failure

Frailty, an aging-related syndrome of physiological decline characterized by marked vulnerability to adverse health outcomes, has attracted increasing attention in cardiology due to the growing elderly population with heart failure. Frail patients are mainly excluded from large cardiovascular intervention studies, and clinical trials addressing frailty and showing an impact on treatment on symptom burden, quality of life and /or outcome has been requested in recent guidelines and consensus documents. The INTEgrRated health CARE for patients with severe frailty and Heart Failure (INTERCARE-HF) is a proof-of-concept study that aims to evaluate the effect of integrated healthcare services for heart failure patients with a severe level of frailty by establishing interdisciplinary and coordinated follow-up teams across the healthcare boundaries. These teams will assess the patient's needs, goals, and risk areas, conduct advance care planning, and develop individualized treatment and follow-up plans. An open-label, non-randomized intervention study aims to recruit 20 patients and heart failure and a clinical Frailty Score (CSF) \>=5. A control-group (N=40) matched on age an clinical frailty scale score will be included. The overall hypothesis is that the intervention is feasible in routine clinical practice with favorable effects on quality of life, symptoms, caregiver distress, and healthcare service utilization.

Participants needed: 60
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Vestre Viken Hospital TrustUpdated: Jun 13, 2024Locations: 1
Eligibility criteria

Age >18 years old [+4]

Inability to comply with all study requirements, due to major co-morbidities or... [+2]

Status: Recruiting

Frailty Syndrome in Daily Practice of Interventional Cardiology Ward

The impact of frailty on immediate and long term outcomes of invasive treatment of coronary artery disease is not fully characterized. The assessment of frailty may help physicians in the selection of best treatment option and in the timing and modality of the follow-up. The FRAilty syndrome in daily Practice of Interventional CArdiology ward (FRAPICA) study is designed with the aim to validate the use of the Fried frailty scale and instrumental activities of daily living scale (IADL) as prognostic tools in patients admitted to hospital for symptomatic coronary artery disease, either stable, unstable, or acute coronary syndrome (ACS). The FRAPICA study is a single center prospective study enrolling patients aged ≥65 years. The aims are (1) to describe Fried frailty scale and IADL scale distribution before hospital discharge and (2) to investigate the prognostic role of Fried frailty and IADL scores. The outcomes are: (1) results of invasive treatment, (2) its complications (periinterventional MI, contrast-induced nephropathy, blood loss), (3) three-year all-cause mortality, cardiovascular mortality, stroke, myocardial infarction, reintervention, heart failure, hospital readmission for any cause, and a composite of the above mentioned. Ancillary analyses will be focused on different clinical presentations, different tools to assess frailty and risk stratification. The FRAPICA program will fill critical gaps in the understanding of the relation between frailty, cardiovascular disease, interventional procedures and outcome. It will enable more personalized risk assessment and identification of new targets for interventions.

Participants needed: 1,000
Trial details
Age: 65+Biological sex: AllType: ObservationalSponsor: Medical University of SilesiaUpdated: Apr 12, 2023Locations: 1
Eligibility criteria

aged ≥ 65 [+2]

lack of consent

Status: Recruiting

Prevalence, Determinants and Natural History of Frailty and Pre-frailty in Elderly People

Frailty syndrome (i.e. frailty) is a geriatric syndrome which relies on the reduction of multisystem reserve capacity. Frail people have a lower potential to respond to external stressors and various life incidents as well as they present a weak prognosis particularly in cardiovascular diseases. Yet, frailty is not only a set of physical deficits, but it also concerns psychological and social dimensions of human functioning. Hence, an approach to frailty should be multidimensional because such a concept more adequately reflects a functional degradation in the elderly. Frailty is usually associated with the impaired condition of circulatory system, and therefore, an identification of subclinical cardiovascular abnormalities is paramount in the frailty prevention and treatment. Another potential mechanism which may predispose to frailty is a dysfunction of the autonomic nervous system. This system plays a crucial role in the response to internal or external stressors such as diseases and activities of daily living. An impairment of the autonomic nervous system function may maintain or accelerate the frailty process. In this scientific project, a comprehensive echocardiography will investigate cardiac function with a particular attention to features which typically change with age, like flow parameters and chambers sizes. The activity of the autonomic nervous system will be explored with the analysis of heart rate, blood pressure and respiratory signals. The study participants will also undergo routine medical examination and a number of additional tests, including: assessment of cognitive function, psychological condition, nutrition status, activities of daily living, and risk of falls. The study group will comprise community dwelling elderly individuals over the age of 65 years who get around by themselves. After 2 years, the participants will be re-examined for their frailty and independence status, as well as their survival will be checked with the National Health Found electronic system. The aim of this project is to seek for factors determining frailty and to explore the frailty impact on the elderly people survival. Particular attention will be paid to the multidimensional frailty which is a new concept of the functional decline in the elderly. In addition, the prevalence of different modes of frailty in Polish community will be investigated. The results of this research should help to establish preventative and therapeutic strategies against frailty.

Participants needed: 1,093
Trial details
Age: 65+Biological sex: AllType: ObservationalSponsor: The Opole University of TechnologyUpdated: Aug 19, 2020Locations: 1
Eligibility criteria

Community dwelling elderly individuals over the age of 65 years who get around b...

Institutionalization [+2]