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Frailty clinical trials

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NCT ID: NCT02214485 Completed - Frailty Clinical Trials

Integrated Care and Lower Extremity Strength Training Among Community-Dwelling Frail Older Adults in Taiwan

Start date: March 2011
Phase: N/A
Study type: Interventional

Objective: To determine the differential effectiveness of integrated care (IC) and lower extremity strength training (LEST) among community-dwelling frail older adults in Taiwan. Method: The investigators randomize participants at Bei-Hu site from the "Intervention study of Geriatric Frailty, Osteoporosis, and Depression in a Community Based Randomized Trial" into 12 weeks of either IC or LEST. Outcome assessments are performed at baseline, 12 weeks and 6 months after initiation of the interventions. Interventions: 1. IC: Participants visit the study site with health education, social activities, warm up, stretch, and low intensity resistance exercise for about 1 hour per week. If any medical problems or functional decline suspected during the visit, the case manager refers participants to their primary care physicians for further managements. 2. LEST: Participants receive 2 sessions of 30-minute lower extremity strength straining using isotonic strength training machines each week. The intensity is set at 60-80% of 1 repetition maximum (RM). Evaluation of the exercise protocol are repeated every 2 weeks for individualized adjustments

NCT ID: NCT02094040 Completed - Frailty Clinical Trials

Municipality-based Post-discharge Follow-up Visits

Start date: February 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether discharge follow-up visit by primary physician and community-based nurse affects the risk of early re-hospitalisation among high risk older people discharged from a medical ward.

NCT ID: NCT02082171 Completed - Physical Disability Clinical Trials

Multidomain Intervention to Prevent Disability in Elders

MINDED
Start date: October 16, 2013
Phase: N/A
Study type: Interventional

Prevention of physical disability represents a major priority for the public health system. Physical disability is the final result of a complex cascade of negative events occurring at different levels (i.e., environmental, social, biological, and clinical). The heterogeneity of the underlying mechanisms responsible for the onset of physical disability may require the adoption of preventive interventions affecting multiple domains. Although several studies suggest that single or different combinations of preventive interventions (in particular, physical activity, cognitive training, and healthy diet) might provide beneficial effects in preventing functional loss (and its related features, such as pain or reduced quality of life), very limited evidence coming from clinical trials is currently available on the topic. Intervention trials are usually designed to test the effect of a specific monodimensional intervention on a very selected population, so to reduce the risk of biased results. This approach, although legitimate and methodologically correct, may 1) be insufficient to target the multiple and heterogeneous physiopathological mechanisms underlying the onset of physical disability, and 2) cause a population selection bias leading to difficulties in implementing the study results to the overall older population (thus, determining the "evidence-based medicine" issue in the elderly). To our knowledge, there are no available data from clinical trials evaluating the effects of a multidomain intervention based on lifestyle modifications (e.g., physical activity, cognitive training, nutritional modification) for preventing mobility disability (a very early phase of the disabling process) in community-dwelling older persons. In the present project (Multidomain Intervention to preveNt Disability in ElDers, MINDED), we propose to conduct a pilot study aimed at estimating the effects of a multidomain person-tailored preventive intervention (based on physical activity, cognitive training, and nutritional modifications) on frailty status, physical performance, cognitive function, nutritional status, health-related quality of life, and use of health care services. In addition, we will perform cost-effectiveness analyses of the proposed intervention. The project will yield the necessary preliminary data to design a definitive full-scale Phase 3 randomized clinical trial. By providing a conclusive answer about the effectiveness of a multidimensional preventive program in the primary prevention of major health-related outcomes, the results of the full-scale trial will have relevant clinical and public health implications, and will promote the practicing of a truly evidence-based geriatric medicine.

NCT ID: NCT02065245 Completed - Frailty Clinical Trials

AllogeneiC Human Mesenchymal Stem Cells (hMSC) in Patients With Aging FRAilTy Via IntravenoUS Delivery

CRATUS
Start date: March 3, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to look at the safety of treatment with stem cells in patients with Frailty.

NCT ID: NCT02041585 Completed - Depression Clinical Trials

Discharge Functional Status and Rehospitalization in the Elderly

DC PROMIS
Start date: October 2012
Phase:
Study type: Observational [Patient Registry]

The DC PROMIS Study (also known as the Discharge Patient Reported Outcomes Measurement Information System Study) is a study to see the effect of patients' social, physical and mental function on their health after hospital discharge.

NCT ID: NCT01973283 Completed - Clinical trials for Major Depressive Disorder

Antidepressant Response in the Treatment of Depressive Symptoms and Frailty Characteristics in Older Adults

Start date: February 19, 2014
Phase: Phase 4
Study type: Interventional

The goal of this open-administration treatment study of citalopram (or duloxetine) is to evaluate the effect of antidepressant medication on treating the syndrome of "frailty" in older adults with depressive symptoms. Patients with significant depressive symptoms (defined as CES-D (Center for Epidemiological Studies - Depression scale) > 10) and 1 or more symptoms of the frailty syndrome (exhaustion, decreased energy, weight loss, decreased grip strength, and slow/unsteady gait) will be evaluated and treated with citalopram (or duloxetine) for 8 weeks to test whether antidepressant medication improves both the syndrome of frailty and depressive symptoms. Patients evaluated at the Adult and Late Life Depression clinic and eligible to participate in the study will be treated with an antidepressant medication and assessed on the primary outcome variables (characteristics of frailty, depressive symptoms) as well as on secondary variables which include cognition (global cognition, episodic memory, executive function), and function (physical mobility, instrumental activities of daily living, and social functioning) prior to treatment initiation and following 8-weeks of treatment. The hypotheses for this protocol predict that we will discover a significant improvement on both frailty characteristics and depressive symptoms in this clinical population when treated with antidepressant medication (citalopram or duloxetine).

NCT ID: NCT01898611 Completed - Frailty Syndrome Clinical Trials

Ghrelin Plus Strength Training in Frail Elderly Study

Start date: July 1, 2013
Phase: Phase 2
Study type: Interventional

Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting (sarcopenia) and unintentional weight loss. There are currently no approved therapies for frailty. Ghrelin is a hormone produced by the stomach that stimulates appetite centers in the brain. The investigators already know that a single dose of Ghrelin improves food intake immediately after the dose in frail older people. In addition, exercise programs have been shown to improve strength and function in older people. In this study, the investigators are trying to find out if a joint intervention of ghrelin and resistance training will improve walking, balance and leg strength in frail elderly people.

NCT ID: NCT01864772 Completed - Clinical trials for Metastatic or Recurrent Head and Neck Squamous Cell Cancer

Phase II Trial of Carboplatin, 5-FU and Cetuximab in Elderly Fit (no Frailty) Patients With Recurrent/Metastatic HNSCC

ELANFIT
Start date: September 2013
Phase: Phase 2
Study type: Interventional

The aim of the trial is to evaluate the clinical benefit (efficacy, safety, preservation of autonomy) of cetuximab-carboplatin-5FU combination as first line treatment of recurrent or metastatic head and neck squamous cell carcinoma in patients over 70 years without frailty (after geriatric assessment).

NCT ID: NCT01605435 Completed - Clinical trials for The Frailty Syndrome

Ghrelin Dose Finding In Frail Elderly

Start date: May 2012
Phase: Phase 2
Study type: Interventional

Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting (sarcopenia) and unintentional weight loss. There are currently no approved therapies for frailty. Ghrelin is a hormone produced by the stomach that stimulates appetite centers in the brain. The purpose of this study is to determine the optimal subcutaneous ghrelin dose as a potential intervention for frail elderly individuals. We will examine food intake and metabolic parameters after placebo and ghrelin administration at three escalating subcutaneously administered doses.

NCT ID: NCT01477086 Completed - Sarcopenia Clinical Trials

Prevalence and Pathophysiology of Sarcopenia in the Elderly Patient With Hip Fracture

PREFISSARC
Start date: January 2012
Phase: N/A
Study type: Observational

Sarcopenia is the loss of muscle mass and function that accompanies aging. The term sarcopenia comes from the Greek "sarx" (flesh) and "penia" (loss). Sarcopenia is a topic of great interest to geriatricians, and from 2010 discussing the possibility of considering it as a geriatric syndrome. Diagnostic criteria are reduced muscle mass, reduced strength and impaired physical performance. The presence of muscle mass reduction set presarcopenia diagnosis, when combined with one of the other two are talking about sarcopenia and when are the three is defined as severe sarcopenia. The hypothesis of our study is that sarcopenia is highly prevalent in older people with hip fracture. The increase in inflammatory indices of older people, along with bed rest, represent factors that accelerate the development of sarcopenia. These factors together could be the base of the high percentage of patients who do not recover the degree of autonomy before the fracture.