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Frailty clinical trials

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NCT ID: NCT02938923 Completed - Sarcopenia Clinical Trials

Starting a Testosterone and Exercise Program After Hip Injury

STEP-HI
Start date: March 5, 2019
Phase: Phase 3
Study type: Interventional

This study is a randomized controlled double-blinded multi-center clinical trial enrolling female hip fracture patients who are 65 and older. It will compare the effects of six months of supervised exercise training combined with daily topical testosterone gel, to six months of supervised exercise and inactive gel, and to Enhanced Usual Care. Out of nine participants, 4 will receive topical testosterone gel and a supervised exercise training program; 4 will receive topical inactive gel and a supervised exercise training program; and 1 will receive a home exercise program. All participants will receive nutritional counseling, and calcium and vitamin D supplements.

NCT ID: NCT02910687 Completed - Frailty Clinical Trials

FINE75+: 5 Year Follow up

FINE75+5
Start date: October 2016
Phase: N/A
Study type: Observational

In the FINE 75+ study, 307 Non ST Elevation Myocardial Infarction (NSTEMI) patients, 75 years old or older, were included between September 2009 and June 2010. The purpose of this observational study (FINE75+5) is to describe these patients, especially regarding the following variables: cardiovascular risk, co-morbidity and frailty, and to assess the prognostic value of frailty on 5-year outcomes. We hypothesize that frailty is independently associated with 5-year mortality.

NCT ID: NCT02838511 Completed - Frailty Clinical Trials

Measure of Frailty in Perioperative Setting

Start date: January 2015
Phase:
Study type: Observational

Though most physicians believe they can identify frail patients, frailty is a poorly characterized and complex clinical syndrome. Frailty has been categorized four dimensions by de Vries et al: 1) physical (physical activity, nutrition, mobility, strength and energy); 2) biochemical (nutritional and inflammatory biomarkers); 3) psychological (cognition and mood); and, 4) social (social contact and support). 1 However, the pathophysiology of frailty remains unclear. Two broad hypotheses have been proposed. Deficit accumulation model: This hypothesis assumes that frailty occurs due to accumulation and additive effect of multiple deficits, which occur across various domains. The more deficits a person has, the more likely that person is to be frail. Frailty in this paradigm is thus measured by identifying the number of positive factors/ deficits from a list. This is used to create a proportional index of deficits, expressed as the ratio of deficits present to the total number of deficits considered. Many studies have used a modified frailty index (MFI) with 11 factors, which has shown to correlate well with patient outcomes after surgery. Phenotype model: Fried et al in 2001 proposed a phenotype based model, in which she identified various clinical features that define frailty as a clinical syndrome. This criterion, known as Fried index, consists of 5 factors- shrinking, weakness, exhaustion, slowness, and low physical activity level. The Fried index is the most commonly used phenotype-based assessment tool to evaluate frailty. An advantage is its ease-of use during preoperative visits. Measurement of these factors in a perioperative setting was further characterized by Makary et al in 2010, and was the basis for the Hopkins Frailty Score (HFS). Currently, there exists no gold standard for assessment of frailty, especially in the perioperative setting. In the absence of a well-accepted gold standard, a measurement of frailty which would predict adverse postoperative outcomes would be useful. However, no study has compared the prognostic abilities of HFS and MFI, after non-cardiac surgery. All adult patients presenting to pre anesthesia evaluation clinic (PACE) at Cleveland Clinic main campus will be included in the this prospective observational cohort study. Frailty would be evaluated prospectively using HFS and components of MFI will be obtained from Cleveland Clinic Perioperative Health Documentation System registry (PHDS).

NCT ID: NCT02816580 Completed - Elderly Persons Clinical Trials

Biological MArkers of FRAilty in Elderly Subjects

MAFRA
Start date: February 23, 2015
Phase: N/A
Study type: Interventional

Epidemiological data from Europe have shown that around 30% of subjects aged over 65 years of age are pre-frail, and 15% are frail. Recent research has demonstrated that identifying frailty and implementing preventive measures can help to slow cognitive decline. Screening and treating frailty seem to be a good start towards preventing dependency. On the premise that this frailty is the result of more pronounced tissue alterations in certain elderly subjects, assessment of post-translational modification derived products (PTMDP) represents an innovative evaluation method. These include advanced glycation end-products (AGE), and carbamylation-derived products (homocitrulline). Indeed, the intensity of these modifications increases with ageing, and assessing the products resulting from these alterations could show the existence of differences according to frailty status. This would make it possible to adapt treatment accordingly in elderly subjects.

NCT ID: NCT02806154 Completed - Cancer Clinical Trials

Frailty and Body Composition in the Elderly Cancer Patients Treated With Chemotherapy

FRACTION
Start date: March 27, 2017
Phase:
Study type: Observational

The investigators could hypothesize that age-related changes in body composition parameters play a role in the variable tolerance to chemotherapy in the elderly.

NCT ID: NCT02804672 Completed - Physical Disability Clinical Trials

Study on Cardiovascular Health, Nutrition and Frailty in Older Adults in Spain

Seniors-ENRICA
Start date: March 2008
Phase:
Study type: Observational

The purpose of this study is to examine the association between ideal cardiovascular health, diet and other lifestyles, biological risk factors, either well-established or emergent, and the risk of frailty in older adults, throughout different waves (2008-10, 2012 and 2015 -16).

NCT ID: NCT02803281 Completed - Lung Cancer Clinical Trials

Assessment of Patient Frailty Prior to Thoracic Surgery

Start date: July 29, 2015
Phase:
Study type: Observational

Determine the feasibility of assessment of measures of frailty and determine if these measures provide a clinically important contribution of risk assessment in a population of patients undergoing major thoracic surgery for lung or esophageal cancer.

NCT ID: NCT02755129 Completed - Heart Failure Clinical Trials

FRailty WAlking Patterns (FRAP) Study

FRAP
Start date: September 20, 2016
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate sit-stand phases and gait speed detection using an externally worn Reveal LINQ (TM) compared to an external reference (3D accelerometer, and/or the Computer Assisted Rehabilitation Environment (CAREN) system) in one center in the Netherlands

NCT ID: NCT02715453 Completed - Fragility Clinical Trials

Intervention in Frailty Versus Usual Care in Frail Patients After an Acute Myocardial Infarction

FRAMIP
Start date: January 2016
Phase: N/A
Study type: Interventional

Frailty has been associated to a worse outcome in acute coronary syndromes, but the best management of frail patients after an acute coronary syndrome remains unknown. The aim was to investigate the benefit of an intervention on frailty in frail patients after an acute myocardial infarction. Patients survivors after an acute myocardial infarction (with and without ST-segment elevation), older than 70 years and with pre-frailty (1-2 points) or frailty (≥3 points) according to the Fried's scale measured 24 hours before hospital discharge, will be included. The participants will be randomized to 2 strategies: a) intervention on frailty in addition to the usual care by the cardiologist, and b) conventional strategy consisting only of the usual care by the cardiologist. A multidisciplinary team (physicians, nurses and physiotherapists and nutritionists) will carry out the intervention on frailty The study contemplates a 2-year inclusion period and a 3rd year for the follow-up of the last included patient. The main outcome will be the frailty status (Fried's scale) at 3 months and 1 year. The secondary endpoint will be the clinical events, both cardiovascular and not cardiovascular events, including recurrent events (cumulative events analysis), for the total follow up (3 years in the case of the first included patient). The hypothesis is that an intervention on frailty will improve frailty status and the clinical outcomes in frail patients after an acute myocardial infarction.

NCT ID: NCT02669927 Completed - Frailty Clinical Trials

Frailty and Postoperative Shock

Start date: January 2013
Phase: N/A
Study type: Observational

To find an objective, affordable and manageable way to measure frailty in elderly patients and to examine relationship between peri-operative metabolism of frail older people and outcome after hip surgery.