Fragility

9

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

Condition / disease
Location
Status: Recruiting

Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients

The goal of this observational and prospective study is to investigate changes in physical performance, lung function, respiratory and peripheral muscle strength in patients during the postoperative period following pulmonary endarterectomy (PET).

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University of Sao Paulo General HospitalUpdated: Jun 22, 2026Locations: 1
Eligibility criteria

Age ≥ 18 years [+3]

Reoperation for any reason [+1]

Status: Recruiting

Sedation Methods in Percutaneous Transhepatic Biliary Drainage: Procedure Quality and Recovery

This prospective, randomized, single-center study aims to evaluate and compare two different sedation and analgesia regimens used during percutaneous transhepatic biliary drainage (PTBD) procedures. A total of 96 adult patients undergoing elective PTBD or biliary stenting will be randomized to receive either propofol-remifentanil or propofol-ketamine sedation. The primary outcome is recovery time assessed using the Modified Aldrete Score. Secondary outcomes include procedure quality, pain scores, patient and operator satisfaction, hemodynamic stability, and the incidence of sedation-related adverse events. The study is designed to determine the optimal sedation strategy for PTBD, particularly in fragile and elderly patient populations.

Participants needed: 98
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Ankara City Hospital BilkentUpdated: Jun 10, 2026Locations: 1
Eligibility criteria

Scheduled for elective percutaneous transhepatic biliary drainage (PTBD) and/or... [+3]

Inability to provide informed consent or to complete study assessments (e.g., Ra... [+7]

Status: Recruiting

IMPACT OF A MULTICOMPONENT PHYSICAL EXERCISE PROGRAM ON THE FUNCTIONAL CAPACITY OF PATIENTS ADMITTED TO AN INTERMEDIATE CARE HOSPITAL. VIVIFRAIL FOR A BETTER VIG-FRAIL.

INTRODUCTION Physical exercise in frail individuals has demonstrated benefits in variables such as reduced mortality risk and improved frailty and quality of life. Specifically, the most beneficial type appears to be multicomponent exercise, which includes strength, endurance, balance, and gait training. Within this field, the VIVIFRAIL project is an internationally recognized physical exercise promotion program. OBJECTIVES To analyze the effects of an individualized multicomponent physical exercise program as an effective method for preventing/improving functional status and frailty in individuals admitted to an intermediate care hospital (ICH). To assess whether improvements in functionality/frailty are maintained 3-4 months after discharge and to evaluate the impact of the program on quality of life variables and health indicators at 6 months. METHODOLOGY Design: randomized clinical trial with two groups (control and intervention) and 6 months of follow-up. Study population: adults older than 65 years admitted to an intermediate care hospital (ICH). Inclusion criteria: baseline Barthel Index ≥60, ability to communicate, ambulate, and complete the exercise program. Primary variables: functionality (Short Physical Performance Battery - SPPB) and frailty (Frail-VIG Index). Secondary variables: grip strength, depressive symptoms, fear of falling, mortality, institutionalization, hospital admissions/emergency room and primary care visits, level of physical activity, medications (number, analgesics, opioid use, antidepressants, anxiolytics), and quality of life. Sample size: assuming a 15% loss to follow-up, the final required sample size is 120 patients. Linear mixed-effects models will be used with a significance level of 0.05.

Participants needed: 120
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUpdated: Jun 9, 2026Locations: 1
Eligibility criteria

baseline Barthel Index ≥60 [+1]

Status: Not yet recruiting

Effects of VIVIFRAIL Program on Functional Capacity and Geriatric Syndromes in the Elderly.

The aim of this quasi-experimental, pretest-posttest study is to evaluate the effectiveness of the Vivifrail multicomponent physical exercise program in improving the functional capacity of pre-frail and frail older adults (aged 70 and older) attending the Virgen del Mar Health Center in Almería. The main questions it aims to answer are: * Does functional capacity, as measured by the Short Physical Performance Battery (SPPB), significantly improve after participating in the Vivifrail program? * What is the effect of the Vivifrail program on various geriatric syndromes and associated health conditions (e.g., fall risk, sarcopenia, chronic pain, mild cognitive impairment, depression), and what patient profile is most likely to benefit from the intervention? * As a single-arm interventional study, there is no parallel comparison group. Researchers will compare each participant's outcomes against their own baseline at three time points (baseline, week 6, and week 12) to assess for significant improvements following the intervention. Participants will: * Complete a 12-week home-based, multicomponent physical exercise program (five sessions per week including strength, balance, flexibility, and aerobic endurance training), tailored to their baseline functional level. * Attend three in-person visits at the health center (baseline, a 6-week follow-up, and a final visit at 12 weeks) for the research staff to assess their clinical, functional, and sociodemographic variables. * Complete an Activity Diary to record their home-based sessions and perceived rate of exertion in order to monitor adherence. * Receive biweekly follow-up phone calls from the research team to reinforce motivation, track adherence, and monitor for any potential adverse events (e.g., falls, pain).

Participants needed: 86
Trial details
Age: 70+Biological sex: AllType: InterventionalSponsor: Elena Pérez Expósito, MDUpdated: Feb 27, 2026Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

Symptoms, Respiratory Dysfunction and Frailty Level in Allergic and Eosonophilic Asthmatics

The aim of this study is to determine the level of respiratory dysfunction, symptoms and frailty in patients with asthma according to different endophenotypes (allergic and eosonophilic asthma). In the light of the data obtained, it is thought that rehabilitation approaches that can be determined according to different endophenotypes in line with the evaluated parameters will guide health professionals working in this field. Hypotheses H0: There is no difference between allergic and eosonophilic asthmatics in terms of pulmonary function, respiratory dysfunction, symptoms, dyspnoea, fatigue, rhinitis, perception of breathlessness in activities of daily living, asthma control, level of frailty or quality of life. H1: There is a difference between individuals with allergic and eosonophilic asthma in terms of pulmonary function, respiratory dysfunction, symptoms, dyspnoea, fatigue, rhinitis, perception of breathlessness in activities of daily living, asthma control, level of frailty or quality of life.

Participants needed: 60
Trial details
Age: 35-75Biological sex: AllType: ObservationalSponsor: Hacettepe UniversityUpdated: Dec 29, 2025Locations: 1
Eligibility criteria

Age between 35-75 years, [+1]

Known cognitive impairment, [+2]

Status: Recruiting

Ischemic Conditioning to Promote Microvascular Resiliency in Frail Individuals

The goal of this clinical trial is to see how small blood vessels respond to the stress of high intensity exercise, and if a safe and simple intervention called ischemic conditioning can protect blood vessels from the stress of exercise. Participants will come in for 3 study visits and get home-based ischemic conditioning. At Study Visit 1, participants will be assessed for their frailty and physical function. Afterwards, they will perform an exercise test. At Study Visit 2, patients will undergo 2 microvascular assessments, perform a high-intensity exercise, then undergo the same 2 microvascular assessments again. Participants will be given a handheld sphygmomanometer and a blood pressure cuff to take home. Depending on which group the participants get randomized into, participants will place the blood pressure cuff around their non-dominant upper arm and inflate to either a low or high pressure for 2 weeks at home. Participants will repeat the same steps in Study Visit 2 for Study Visit 3. In addition, participants will also be assessed for their frailty and physical function.

Participants needed: 60
Trial details
Phase: Phase 2Age: 65-85Biological sex: AllType: InterventionalSponsor: Medical College of WisconsinUpdated: Sep 23, 2025Locations: 1
Eligibility criteria

Women and men ages 65-85 years of age

Myocardial infarction in last 6 months [+6]

Status: Recruiting

Impact of Nutritional Management on the Frailty of Patients Waiting for Liver Transplantation (Via the LFI Tool)

Cirrhosis is a major public health issue responsible for about 15000 deaths each year. Liver transplantation (LT) remains the only curative treatment for decompensated cirrhosis. Decompensated cirrhotic patients awaiting LT are malnourished, sarcopenic and fragile. The evaluation of the nutritional status of these patients is complex because the anthropometric data that define undernutrition (weight variation, BMI) are often compromised by the presence of edema and ascites related to liver disease. It therefore seems appropriate to focus on the fragility and sarcopenia of the cirrhotic patient as a reflection of the nutritional status. In 2017, the American team of Lai et al. validated a Liver fraily index (LFI) score of frailty specific to cirrhotic patients waiting for LT. The LFI is composed of three simple physical tests (Grip test, chair lift test, and balance tests) performed at the patient's bedside, which results in a quantitative and reproducible frailty score. Frailty while waiting for LT is associated with an increase in mortality on the waiting list, independently of the MELD (Model for End stage Liver disease) score, which is a reflection of liver severity. About half of the patients who are candidates for LT will present an aggravation of their frailty while waiting for LT. To date, no study has reported the results of a nutritional intervention on the evolution of fragility in patients awaiting LT. The objective of our study is to evaluate the impact of a nutritional management and follow-up by a dietitian specialized in hepatology on the fragility of patients waiting for LT. This is a monocentric study, randomized in two parallel groups (an intervention group with nutritional follow-ups by a trained dietitian and a control group with follow-up by the reference hepatologist without specific dietary management by a dietician) in open. All patients enrolled on the LT list with an LFI \> 3.2 (pre-frail and frail state) will be included in the study. It is planned to include 210 patients over a period of 24 months. The LFI will be measured for all patients (control group + intervention group) at 3 and 6 months, as part of their follow-up in the LT center. This study will also make it possible to correlate frailty with other parameters (severity of liver disease, access to LT).

Participants needed: 210
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Hospices Civils de LyonUpdated: Jul 4, 2025Locations: 1
Eligibility criteria

Patient aged ≥ 18 years [+3]

Patient hospitalized in intensive care [+9]

Status: Recruiting

Optimized Recovery After Trauma in Geriatric Patient

Currently, there is evidence that structured care within the healthcare system increases the conditions for good care and better recovery. We want to investigate whether a new care concept (gero-ERAT) that combines two variants of structured care can improve the recovery of elderly patients affected by a physical trauma. Our hope is that the project will reduce the complications, short care times, fewer re-admissions and that more patients can return to regular living, which reduces the suffering for the patient and his relatives. In addition to patient benefit, a successful outcome will also result in reduced costs for healthcare and society as a whole. The concept of care is based on an increased patient participation, which is in line with the values of the Västra Götaland region and the Sahlgrenska university hospital Through the PhD project, four studies will be published. A qualitative interview study to investigate patients' experiences of care and recovery after trauma. After that, a prospective cohort survey of two groups is carried out; conventional care and gero-ERAT. Data will begin to be collected in the control group and when the control group is full geroRATAT will be implemented in the care department and we then collect data in the intervention group. Based on collected data, we will publish two additional studies one with a focus on health economics as well as one focusing on care time and recovery based on age and harvest estimation.

Participants needed: 540
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: Vastra Gotaland RegionUpdated: Nov 25, 2024Locations: 1
Eligibility criteria

≥ 65 years old [+2]

Documented palliative care [+1]

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]