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Frailty clinical trials

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NCT ID: NCT03913299 Recruiting - Surgery Clinical Trials

Frailty Assessment by Edmonton Frail Scale to Predict Outcome in Patients Undergoing Cardiovascular Surgery

FRAIL-HEART
Start date: April 23, 2019
Phase:
Study type: Observational [Patient Registry]

The aim of the study is to assess frailty of patients admited for cardio-vascular surgery in Cliniques Universitaires Saint Luc in Brussels. And analyse the correlation between frailty, functionnal decline and postoperative mortality.

NCT ID: NCT03880422 Recruiting - Obesity Clinical Trials

Nutrition and Exercise Interventions in Reducing Androgen Deprivation Therapy-Induced Obese Frailty in Prostate Cancer Survivors

Start date: May 2, 2019
Phase: N/A
Study type: Interventional

This trial studies how well nutrition and exercise interventions work in reducing androgen deprivation therapy-induced obese frailty in prostate cancer survivors. Individualized nutrition and exercise advice for prostate cancer patients on androgen deprivation therapy may help to reduce obese frailty and change the levels of myokines in blood.

NCT ID: NCT03842579 Recruiting - Physical Frailty Clinical Trials

Protein and Exercise to Counteract Frailty in Older Adults

Start date: February 13, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effects of interventions with high-protein diet alone or in combination with resistance training on muscle mechanical function (muscle power and strength), frailty status, functional performance, muscle mass and quality of life.

NCT ID: NCT03824106 Recruiting - Frailty Clinical Trials

Frailty Rehabilitation

Start date: September 2, 2022
Phase: Phase 4
Study type: Interventional

Frailty is an important clinical state that contributes to falls, hospitalization, institutionalization and death. When an individual simultaneously has many health problems, a frailty "tipping point" may be triggered by even a minor stressful event such as adding a new drug or urinary tract infection. Our research suggests that approximately 23% of Canadians over age 65 are frail, and by age 85 this estimate increases to over 40%. As we learn more about frailty and its consequences, there is an urgent need to develop community-based interventions that will prevent or delay frailty in older adults. Our proposed study will examine if frailty rehabilitation program is an effective community-based intervention to promote healthy aging. The primary objective of our study is to determine if 4-month frailty rehabilitation improves physical function compared with control and exercise alone in community-dwelling older adults living with frailty and sarcopenia. Secondary objectives of our study are to determine if 4-months of frailty rehabilitation can improve functional abilities and reduce healthcare utilization during a 6-month follow-up period compared with control and exercise alone. Results will translate the first Canadian model of frailty and sarcopenia rehabilitation and management.

NCT ID: NCT03801460 Recruiting - Frailty Clinical Trials

Physiological Reconditioning Program Administered Remotely in Patients Undergoing Transcatheter Aortic Valve Replacement: A Pilot Study

PREPARE-TAVR
Start date: July 1, 2020
Phase: N/A
Study type: Interventional

The PREPARE TAVR pilot study will examine the effects of remotely administered physiological reconditioning program (RAPR) on quality of life (QOL) and clinical outcomes at one year post TAVR in frail older adults.

NCT ID: NCT03782519 Recruiting - Frailty Clinical Trials

Quality of Life of Frail Aged Patients in Incremental Hemodialysis

Qualifragilys
Start date: May 9, 2019
Phase: N/A
Study type: Interventional

End stage renal disease (ESRD) is a major public health problem. The dialysis population is aging. As a result we observe a high prevalence of frailty among dialysis patients (ranges from 3 to 10 fold higher than in the comparably aged general public). Frailty is a medical syndrome characterized by diminished strength, endurance, and reduced physiologic function that increases an individual's vulnerability for developing increased dependency and/or death. Without systematic approach it is difficult for physicians to detect frailty phenotype which however might be reversible or attenuated by interventions. Fried et al. developed a frailty phenotype consisting of 3 or more of: unintentional weight loss, exhaustion, physical inactivity, slow gait speed, and weak grip strength. The primary care of hemodialysis patient is often supported by the nephrologist. Identification of frailty is integrated into the primary care setting as one of the steps necessary for the overall assessment of the person and planning to formal prevention interventions in an individualized care plan. Thrice-weekly hemodialysis (HD) schedules are the standard default hemodialysis prescription in Western countries, imposed in the 70s. For incremental HD, the weekly dose of dialysis is based on variety of clinical factors such as residual kidney function, volume status, cardiovascular symptoms, potassium level, nutritional status and, comorbid conditions. Incremental HD scheme generally starts with 2 weekly sessions and then periodic monitoring of criteria mentioned above are used to determine the timing for increasing dialysis dose and frequency to 3 weekly sessions. An approach that integrates systematic frailty phenotype assessment by nephrologists and individualized incremental HD therapy can be beneficial within the first year of HD. It could optimize health-related quality of life and other pertinent outcomes without affecting negatively the quality of dialysis. The purpose of this study is to evaluate for frail aged incidents hemodialysis patients the impact of implementation of an incremental HD on HRQoL compared to conventional HD.

NCT ID: NCT03720041 Recruiting - Multiple Myeloma Clinical Trials

Myeloma XIV: Frailty-adjusted Therapy in Transplant Non-Eligible Patients With Newly Diagnosed Multiple Myeloma

FiTNEss
Start date: August 4, 2020
Phase: Phase 3
Study type: Interventional

Trial Title: FiTNEss (UK-MRA Myeloma XIV) - Frailty-adjusted therapy in Transplant Non-Eligible patients with newly diagnosed Multiple Myeloma Overview: A phase III, multi-centre, randomised controlled trial to compare standard (reactive) and frailty-adjusted (adaptive) induction therapy delivery with the novel triplet ixazomib, lenalidomide and dexamethasone (IRD), and to compare maintenance lenalidomide (R) to lenalidomide plus ixazomib (R+I) in patients with newly diagnosed multiple myeloma not suitable for a stem cell transplant. All participants receive induction treatment with ixazomib, lenalidomide and dexamethasone and are randomised on a 1:1 basis at trial entry to the use of frailty score-adjusted up-front dose reductions vs. standard up-front dosing followed by toxicity dependent reactive dose-modifications during therapy. Following 12 cycles of induction treatment participants alive and progression-free undergo a second randomisation on a 1:1 basis to maintenance treatment with lenalidomide plus placebo versus lenalidomide plus ixazomib. Participants and their treating physicians will be blinded to maintenance allocation. Participant population: - Newly diagnosed as having Multiple Myeloma (MM) according to the updated IMWG diagnostic criteria 2014 (see Appendix 1 for criteria) - Not eligible for stem cell transplant - Aged at least 18 years - Able to provide written informed consent Number of participants: 740 participants will be entered into the trial at Randomisation 1 (R1), with 478 participants at Randomisation 2 (R2). Objectives: The primary objectives of this study are to determine: - Early treatment cessation (within 60 days of randomisation) for standard versus frailty-adjusted up-front dosing - Progression-free survival (PFS, from maintenance randomisation) for lenalidomide + placebo (R) versus lenalidomide + ixazomib (R+I) The secondary objectives of this study are to assess progression-free survival (PFS) for standard versus frailty-adjusted up-front dosing reductions, time to progression, time to 2nd PFS event (PFS2), overall survival (OS), survival after progression, deaths within 12 months of R1, overall response rate (ORR), attainment of ≥VGPR, attainment of MRD negativity, duration of response, time to improved response, time to next treatment, treatment compliance and total amount of therapy delivered, toxicity & safety including the incidence of SPMs, Quality of Life (QoL), cost effectiveness of standard versus frailty-adjusted up-front dosing of IRD and cost-effectiveness of R + I versus R. Exploratory objectives are prospective validation of a novel frailty risk score (UK-MRA Myeloma Risk Profile - MRP), usefulness of Karnofsky Performance Status (PS), and association of molecular subgroups with response, PFS and OS.

NCT ID: NCT03696134 Recruiting - Clinical trials for Musculoskeletal Pain, Frailty, Disability

Investigating Musculoskeletal Health and Wellbeing

Start date: June 22, 2018
Phase:
Study type: Observational

Background The progression and associations of central and peripheral musculoskeletal pain, frailty, disability and fracture risks are not well known. This study aims to characterise the development and progression of different frailty, pain and disability phenotypes and their individual associations. Methods A prospective cohort of 10000 people aged > 18 will be recruited from general practice surgeries, secondary care and the general public. Data collection waves will be at baseline,and then annual follow-ups for up to five years. Data will be collected using a questionnaire asking about demographic characteristics, pain severity (0-10 scales), pain distribution (a pain Mannikin), pain quality (the McGill Pain Questionnaire), central pain (the CAP-Knee Scale), fracture risks (a modified version of the FRAX instrument), frailty (the Fried Criteria and the FRAIL scale) and disability (the FRAIL scale). Discussion Participant data will be analysed to determine phenotypic subgroups of frailty, pain and disability. Further to this, the progression of these characteristics and their influences upon health and wellbeing will be quantified.

NCT ID: NCT03680677 Recruiting - MDS Clinical Trials

Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies

Start date: September 21, 2018
Phase:
Study type: Observational

The purpose of this research study is to determine if frailty assessments can be used to predict how well patients aged 60 years and older will do after chemotherapy, CAR T-cell therapy, or allogeneic stem cell transplant.

NCT ID: NCT03668821 Recruiting - Clinical trials for Peripheral Artery Disease

Frailty in Vascular Patients Undergoing Surgery

Start date: January 1, 2021
Phase:
Study type: Observational

An observational cohort study of the frailty of vascular surgery patients undergoing intervention and their outcomes.