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Frailty clinical trials

View clinical trials related to Frailty.

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NCT ID: NCT06070532 Not yet recruiting - Frailty Clinical Trials

A Study of Human Allogeneic Bone-marrow-derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Aging Frailty

Start date: January 1, 2025
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this phase I/II clinical trial is to evaluate the safety and tolerability of intravenous infusion of human allogeneic bone-marrow-derived mesenchymal stromal cell product StromaForte in patients with aging frailty. The main questions it aims to answer are: To assess the safety and tolerability after 28 days of injection by reporting the number of adverse events assessed by Common Terminology Criteria For Adverse Events (CTCAE) Observe the change in inflammatory markers from baseline to 6 months (baseline to 28, 84, and 168 days post-infusion.) Participants will receive 100 x 106 allogeneic bone marrow (BM)-derived Mesenchymal Stromal Cell (MSC) formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion 100 million cells in approximately 30 min

NCT ID: NCT06069297 Recruiting - Pancreatic Cancer Clinical Trials

Prehabilitation in Pancreatic Surgery

PIPS
Start date: July 14, 2023
Phase: N/A
Study type: Interventional

In patients with pancreatic cancer, older age, multiple comorbidities, frailty, malnutrition and poor functional status are common, especially in individuals receiving neoadjuvant chemotherapy. These characteristics represent potentially modifiable risk factors for poor postoperative outcomes. The goal of this clinical randomized controlled trial is to evaluate the extent to which a four-week multimodal prehabilitation program impacts on postoperative morbidity, functional and nutritional status and health-related quality of life in patients with localized pancreatic or periampullary cancer scheduled for curative surgery. In addition, the impact of prehabilitation on circulating sarcopenia and cancer cachexia biomarkers in PDAC patients will be explored. Included patients will be randomized (ratio 1:1) and allocated either to the intervention group (Multimodal Prehabilitation), which will receive prehabilitation, or to the control group, which will receive no prehabilitation.

NCT ID: NCT06068543 Not yet recruiting - Inflammation Clinical Trials

Reducing Frailty for Older Cancer Survivors Using Supplements II

ReFOCUS2
Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

This study is a two-arm placebo controlled randomized clinical trial, to assess the effect of a 12-week EGCG intervention on physical frailty compared to placebo in pre-frail older cancer survivors.

NCT ID: NCT06064227 Completed - Frailty Clinical Trials

The Effect of Health Promotion Comprehensive Education Intervention on the Frailty Levels of Elderly Family Caregivers

Start date: June 15, 2023
Phase: N/A
Study type: Interventional

This study was conducted to evaluate the effect of a comprehensive health promotion educational intervention applied to family caregivers over the age of 60 on their fragility levels. The main question(s) it aims to answer are: - Does the educational intervention have a significant impact on caregivers' vulnerability? - Does the educational intervention have a significant impact on caregivers' quality of life? The population of the study consists of family members who care for individuals receiving home health services in public hospitals in Antalya city center. G power test was used to determine the number of samples and the result of the analysis on the subject; Alpha value of 0.01 for independent sample t test at 95% confidence level; Taking an effect size of 1.35 and theoretical power of 99%, the minimum total sample size was determined as 58 people, 29 for each group. It was thought that it would be appropriate to take 30% more than the calculated minimum sample number due to possible losses that may occur during the research process, and as a result, it was decided to recruit 40 people for each group. In the study, the Participant Information Form developed by the researcher, the Health Promoting Lifestyle Profile (HPLP) scale, the frailty (FRAIL) scale and the World Health Organization quality of life scale for elderly individuals will be applied to family caregivers. SPSS statistical software package will be used in the analysis of the data obtained.

NCT ID: NCT06063590 Recruiting - Aging Frailty Clinical Trials

A Study to Evaluate Allogenic Bone-Marrow Mesenchymal Stromal Cell Product StromaForte in Aging Frailty Patients

Start date: November 28, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/IIa study in frail patients is designed to assess the safety of intravenous human allogenic bone marrow-derived mesenchymal stromal cell product StromaForte by reporting the number of adverse events assessed by Common Terminology Criteria. 12 male and female patients aged 60 to 85 years will be enrolled.

NCT ID: NCT06056934 Recruiting - Clinical trials for Cognitive Deterioration

Pain Management in Elderly Patients With or Without Cognitive Frailty Hospitalized "ALGOGER"

ALGOGER
Start date: March 9, 2023
Phase:
Study type: Observational

Today, the standard treatment is to operate on patients suffering from a fracture of the upper end of the femur. The aim of treatment is to enable immediate mobilization and weight-bearing, and as rapid a return as possible to normal living conditions. Surgery is the best treatment option. It maximizes the chances of functional recovery and, by stabilizing the fracture, reduces pain: it is the most effective and longest-lasting analgesic. Adequate analgesia in elderly patients with femoral neck fractures has a beneficial effect. In particular, a lower probability of death has been shown in cervical fracture patients receiving opioids than those not receiving them. Pain management is a matter of protocol in the UPOG department of the CHU de Nîmes. Pain prevention appears to improve morbidity and mortality. Cognitive fragility, such as neurocognitive disorders, confusion or long-term use of psychotropic drugs, appear to be confounding factors in pain management. The investigators therefore wished to observe whether the presence of cognitive fragility has an impact on pain management on the ward, despite protocol-based management.

NCT ID: NCT06055387 Recruiting - Gastric Cancer Clinical Trials

Frailty Assessment and Intervention in Elderly Patients With Gastric Cancer Receiving Gastrectomy and Adjuvant Chemotherapy

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Gastric cancer ranks among the top ten leading causes of death in Taiwan. Radical surgery is the sole curative method for gastric cancer. However, our previous research has revealed that elderly gastric cancer patients undergoing radical surgery face a significantly elevated risk of postoperative complications. Even after gastric cancer resection, only 70% of patients receive adjuvant chemotherapy, with a particularly low likelihood among those aged ≥ 65 to undergo such treatment. With the increasing elderly population in our country, an increasing number of elderly gastric cancer patients must decide whether they can withstand radical surgery for gastric cancer and whether to undergo adjuvant chemotherapy. Therefore, increasing the rates of elderly gastric cancer patients undergoing radical surgery and adjuvant chemotherapy, as well as improving the success rate of chemotherapy, has become a critical issue. Frailty has been a frequent topic in geriatric medicine in recent years. It involves assessing multifaceted aspects of physical functioning to determine an individual's frailty status, which can help predict the likelihood of severe side effects from medical interventions. International organizations like the American Cancer Society recommend frailty assessment for all elderly cancer patients before undergoing chemotherapy and corresponding interventions to address frailty. However, there is a lack of large-scale studies on frailty assessment and its practical clinical benefits in our population. This study is a prospective, open-label, randomized clinical trial designed to investigate the impact of geriatric intervention on the tolerance of surgery/chemotherapy in patients diagnosed with gastric cancer. As part of the study protocol, all enrolled patients will undergo a comprehensive frailty assessment within a window of 7 days before initiating their first treatment, followed by tailored geriatric interventions. The primary objective of this study is to assess and compare the effects of geriatric intervention on postoperative complications, chemotherapy tolerance, treatment-related toxicity, and overall quality of life among two distinct groups: frail and non-frail patients. Our research team aims to promote widespread frailty assessment and interventions with the following objectives: 1. Reduce the probability of postoperative complications among elderly gastric cancer patients receiving surgery. 2. Enhance the tolerance and success rate of adjuvant chemotherapy for gastric cancer. These efforts ultimately aim to improve the survival prognosis of this patient group.

NCT ID: NCT06044298 Not yet recruiting - Frailty Clinical Trials

Advers Events in Patients Undergoing Gastrointestinal Procedural Sedation

Start date: January 2024
Phase:
Study type: Observational

Investigators will include in our study patients aged 60 and over who have been evaluated in the pre-anesthesia clinic for procedures such as endoscopy, colonoscopy, ERCP, PEG, EUS, and ESD, and who have received sedation by an anesthesiologist. Patients will be assessed for frailty prior to the procedure; during and after the procedure, respiratory monitoring (SpO2, capnography) will be closely observed, and they will be contacted by phone three days later. Primary goal of the study is to prospectively investigate the incidence of peri-procedural complications (desaturation, bradycardia, hypotension, etc.) in elderly patients undergoing gastrointestinal procedural sedation, and to assess its relationship with detected frailty using the FRAIL scale.Secondary goals of the study are to identify risk factors for adverse events, examine the relationship of these factors with 'ASA score - age and frailty scale', and determine their impact on the incidence of adverse events. Additionally, investigators aim to research the effects of capnography-based respiratory monitoring on adverse events.

NCT ID: NCT06042244 Enrolling by invitation - Multiple Sclerosis Clinical Trials

Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis

Start date: November 20, 2023
Phase: N/A
Study type: Interventional

Study Significance: This proposed investigation is designed to examine the feasibility of an exercise-based intervention to reduce frailty in people living with MS. The proposed research will be the first to establish the feasibility of targeting frailty in pwMS and will begin to examine the dynamic nature of frailty in MS. These advances will pave the way for planned prospective studies toward effective targets for diagnostics, and rehabilitation of frailty in MS.

NCT ID: NCT06040658 Recruiting - Surgery Clinical Trials

Frailty Assessment in Vascular Hot Clinic Setting - Feasibility and Prognostic Value

FAVOUR
Start date: March 15, 2023
Phase:
Study type: Observational

A single-centre prospective study of feasibility assessing the suitability of introducing routine frailty screening in a controlled, and reproducible, outpatient department setting for Vascular Surgery patients. This study will also perform head-to-head comparisons of the prognostic value of five frailty assessment tools, selected based on the previous demonstration of their popularity and familiarity within the speciality, their designs being based on different theories of frailty and that some are endorsed by local healthcare police. Inter-user variability (patient self assessment and clinician assessment will also be compared).