Frail Elderly

16

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

Condition / disease
Location
Status: Not yet recruiting

Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults

Brief Summary This clinical study aims to compare the effects of a conventional exercise program and a Pilates exercise program in prefrail and frail older adults. A total of 40 participants aged 60 years and older who are classified as prefrail or frail according to the FRAIL Scale will be included in the study. Participants will be randomly assigned to either the conventional exercise group or the Pilates group. Both exercise programs will be conducted twice weekly for 6 weeks. The interventions will focus on stretching exercises, balance and perturbation training, and strength exercises targeting major muscle groups. Primary outcomes will include changes in frailty status assessed before and after the intervention. Secondary outcomes will include functional mobility and balance assessed by the Timed Up and Go Test, dynamic balance assessed by the Functional Reach Test, lower extremity strength assessed by the 30-Second Sit-to-Stand Test, gait speed assessed by the 10-Meter Walk Test, depressive symptoms and psychological well-being assessed by the Yesavage Geriatric Depression Scale, independence in daily activities assessed by the Lawton Instrumental Activities of Daily Living Scale, cognitive status assessed by the Mini-Mental State Examination, and fatigue assessed by the Modified Borg Scale. Frailty status will be evaluated using the FRAIL Scale. Throughout the study, participant safety will be monitored, and any adverse events, such as injuries or discomfort occurring during exercise sessions, will be recorded and managed appropriately. This study is expected to provide valuable clinical evidence regarding the effectiveness of conventional exercise and Pilates programs in improving physical health and reducing frailty in prefrail and frail older adults, thereby contributing to the identification of best practice approaches for the management of this vulnerable population.

Participants needed: 40
Trial details
Age: 60+Biological sex: AllType: InterventionalSponsor: Istanbul University - CerrahpasaUpdated: Jun 25, 2026
Eligibility criteria

Age 60 years and older Classified as prefrail or frail according to the FRAIL Sc...

Status: Recruiting

Clinical Efficacy of a Multicomponent Exercise and Comprehensive Geriatric Assessment Program (FRAIL+AP) in Frail Older Adults Within Primary Care: A Randomized Controlled Trial

Frailty is a multidimensional clinical syndrome associated with increased vulnerability to adverse health outcomes in older adults. Despite strong evidence supporting multicomponent exercise interventions, their implementation in primary care settings remains limited. This randomized controlled trial aims to evaluate the efficacy of the FRAIL+AP program, which integrates Comprehensive Geriatric Assessment (CGA) with a 12-week multicomponent exercise intervention, including visual-spatial gait retraining using the Tapiz Fisior system. The study will assess whether this intervention improves frailty status, physical performance, and functional independence, while reducing falls among community-dwelling older adults compared to standard care.

Participants needed: 200
Trial details
Age: 70+Biological sex: AllType: InterventionalSponsor: Universidad Europea de MadridUpdated: Jun 11, 2026Locations: 1
Eligibility criteria

Community-dwelling adults aged 70 years or older. [+8]

Absolute contraindications to physical exercise, including recent acute myocardi... [+9]

Status: Recruiting

Up-2 Study: Cognitively Engaging Walking Exercise and Neuromodulation to Enhance Brain Function in Older Adults

Declines in cognitive function and walking function are highly intertwined in older adults. A therapeutic approach that combines complex (cognitively engaging) aerobic walking exercise with non-invasive electrical brain stimulation may be effective at restoring lost function. This study tests whether electrical stimulation of prefrontal brain regions is more beneficial than sham stimulation.

Participants needed: 120
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: University of FloridaUpdated: Jun 3, 2026Locations: 2
Eligibility criteria

Age 65+ [+3]

Major cognitive disorder that interferes with independence [+3]

Status: Recruiting

High Intensity Interval Training Versus Moderate Intensity Continuous Training in Frail Elderly

The assessment and systematic integration of physical activity into the care pathway of frail elderly people is essential to prevent loss of independence and improve the quality of life of this population. This project, which is part of routine care, aims to evaluate the practices and, in particular, the effects of different types of physical exercise currently in use at the Health and Sport Center of the Grenoble Alpes University Hospital. It therefore aims to optimize professional practices without changing the standard care provided to patients. Recommendations regarding intensity during cardiorespiratory endurance training sessions (moderate to high, taking into account emotional factors) are broad and vary greatly in their application depending on the facilities that work with older adults. This project aims to compare the exercise methods used on ergocycle at Health and Sport Center of Grenoble Alpes University Hospital: high-intensity interval training (HIIT) vs. moderate-intensity continuous training (MICT) to reverse the functional decline that occurs in frail older adults.

Participants needed: 92
Trial details
Age: 70+Biological sex: AllType: ObservationalSponsor: University Hospital, GrenobleUpdated: May 5, 2026Locations: 1Duration: 6 Months
Eligibility criteria

Adults aged 70 or older; [+5]

Unstable medical conditions that may be aggravated by physical activity (as dete... [+3]

Status: Recruiting

Pre-operative Risk Assessment Combined With Targeted Intervention in the Chinese Elderly With Spine Surgery II

This multicenter, parallel-group, assessor-blinded randomized controlled trial will enroll 248 adults aged ≥75 years with degenerative lumbar spinal diseases scheduled for elective lumbar fusion surgery, and they will be randomized 1:1 into the intervention and usual care groups. The intervention group will receive a 6-week PHYSIO-Prehab multimodal prehabilitation program, including multicomponent exercise, nutritional intervention, comorbidity optimization, and cognitive prehabilitation with brain protection strategies. The control group will receive standard health education provided via a manual, and both groups will receive consistent perioperative Enhanced Recovery After Surgery care. The primary outcome will be the change in Barthel Index (a tool for assessing independence in activities of daily living) from baseline to 30 days postoperatively; secondary outcomes will include pain scores, disability, patient satisfaction, and the 30-day postoperative Comprehensive Complication Index. The trial will initiate recruitment in April 2026 and conclude in December 2027, aiming to evaluate the feasibility and efficacy of PHYSIO-Prehab and provide high-quality evidence for patient-centered perioperative care pathways in this population.

Participants needed: 248
Trial details
Age: 75+Biological sex: AllType: InterventionalSponsor: Xuanwu Hospital, BeijingUpdated: Apr 28, 2026Locations: 4
Eligibility criteria

Aged ≥75 years at the time of screening [+5]

Scheduled to undergo other emergency surgery or day surgery [+6]

Status: Not yet recruiting

EFFECT OF ANIMATION-BASED DIGITAL EDUCATION ON RISK KNOWLEDGE AND FRAILTY IN OLDER ADULTS

With the global aging trend, the management of geriatric risks faced by older adults and the effectiveness of health education for this population are gaining increasing importance. Literature indicates that health education for older adults, when delivered through methods that support individual engagement and the use of digital tools, yields more effective results in terms of learning and behavior change. This doctoral study aims to evaluate the effect of a digital education model, structured based on the Health Belief Model and developed using branching scenario animation technique, on geriatric risk knowledge level and frailty status among older adults residing in nursing homes. The study will be conducted as a randomized controlled trial in three nursing homes in Istanbul, with measurements at baseline (T0), immediately post-intervention (T1), 1-month follow-up (T2), and 3-month follow-up (T3). Based on power analysis, 66 participants will be randomly assigned to intervention and control groups (33 per group) using block randomization. The intervention group will receive scenario-based digital animation education developed on the Vyond platform and structured according to the theoretical components of the Health Belief Model. The control group will receive standard care during the study period and will be offered the same digital animation education after completion of all assessments (post 3-month follow-up). The primary outcome is geriatric risk knowledge level, assessed using an interactive digital game called "Knowledge Wheel." Secondary outcomes include frailty status, measured by the Edmonton Frail Scale, and technology acceptance. Changes in knowledge and frailty levels measured through assessment tools will reveal the short- and medium-term effects of the education. Thus, the model's impact on health-related behavior change in older adults will be comprehensively evaluated. The unique aspect of this study is that it will be one of the first experimental studies to implement an interactive scenario-based digital education model in older adults. The findings are expected to contribute to the development of age-friendly health education models.

Participants needed: 66
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: Saglik Bilimleri UniversitesiUpdated: Apr 23, 2026
Eligibility criteria

Aged 65 years or older [+5]

Diagnosis of cognitive impairment or dementia [+3]

Status: Recruiting

Targeting Aging With a Ketone Ester for Function in Frailty

This study aims to find out if a food supplement that contains a naturally occurring substance, ketones, can help to improve strength and general wellness in adults at, or over the age of 65 years who are experiencing a slight decline in their physical function. Participation will involve a screening visit and 4 additional study visits over the course of 20 weeks. After being assessed for eligibility, study participants will be sorted into two groups at random and consume either a ketone or placebo supplement at home every day for 20 weeks. Both study products can cause gastro-intestinal side effects in some individuals. At all study visits, subjects will provide blood samples. At three study visits, subjects will be asked to complete physical performance tests, provide blood, stool and urine samples. They will also complete questionnaires during three study visits to assess physical function, markers of inflammation, and other aspects of general well-being. The study enrolls at three sites across the United States, in California (Buck Institute), Ohio (Ohio State University), and Connecticut (University of Connecticut). The study is coordinated by the San Francisco Coordinating Center (California Pacific Medical Center).

Participants needed: 180
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: Buck Institute for Research on AgingUpdated: Mar 13, 2026Locations: 3
Eligibility criteria

Subject is greater than or equal to 65 years of age, inclusive at Screening. [+4]

Subject is non ambulatory. [+23]

Status: Recruiting

Comparison of Smartphone and Community-Based Delivery of the Otago Exercise Program for Fall Risk in Older Adults

The long-term goal of this project is to effectively bridge the research-clinic-community gap and to foster partnerships that support the implementation, utilization, and advocacy of evidence-based fall prevention programs in the older adult community. The Otago Exercise Program (OEP) is an evidence-based fall prevention program that has been shown to reduce falls and fall-related injuries among older adults. Traditionally, OEP is delivered in the home by a physical therapist and focuses on muscle strengthening and balance training. Despite its proven effectiveness, adherence and compliance rates have been low. The personnel and resource demands of program delivery, along with challenges in monitoring participant adherence, represent significant barriers to broader implementation. Alternative delivery systems using remote and community-based platforms may help address these limitations. Specific Aim 1: To compare the effectiveness of two delivery modes of the Otago Exercise Program: a remotely delivered, home-based smartphone program and an in-person, community-based program. Specific Aim 2: To examine the feasibility, acceptability, and usability of the Otago Exercise Program delivered through both smartphone-based and in-person formats.

Participants needed: 30
Trial details
Age: 55+Biological sex: AllType: InterventionalSponsor: Binghamton UniversityUpdated: Feb 25, 2026Locations: 1
Eligibility criteria

Community-dwelling older adults 55 years of age or older [+5]

Lower limb amputation [+5]

Status: Not yet recruiting

Community-Based Program Integrating Nurse-Led Mind-Body Exercise and Nutrition for Frailty

This study aims to develop and evaluate a community-based rehabilitation program integrating nurse-led mind-body exercises and nutritional supplementation for frail older adults in Indonesia. This study uses a Randomized Controlled Trial (RCT) with three parallel groups and assessor blinding. The intervention was conducted for 8 weeks in community-dwelling older adults aged ≥ 65 years who live within the working area of a Community Health Center in Surabaya City. The sample size is 48 elderly. Participants will be divided into 3 groups: the control group, the Nurse-Led Mind-Body Exercise group, and the MBE + Nutritional Supplementation (MBE + Nutrition) group. The procedure is carried out after respondents provide voluntary consent. Confidentiality and anonymity of data will be strictly maintained throughout the research process. Data analysis between groups and within groups will be conducted using repeated-measures ANOVA and Intention-to-treat (ITT) analysis.

Participants needed: 48
Trial details
Age: 65-75Biological sex: AllType: InterventionalSponsor: Universitas AirlanggaUpdated: Feb 18, 2026Locations: 1
Eligibility criteria

Eligibility criteria included age ≥65 years, a Frail Scale score of 1-3 (pre-fra...

Exclusion criteria included severe cardiac or respiratory conditions (contraindi...

Status: Not yet recruiting

FreeFrail Project: A Multicomponent Intervention for the Management of Frailty in Primary Care: A Randomized Controlled Trial

The primary aim is to assess the effectiveness of a multicomponent intervention including dual-task exercise in improving functionality and cognitive performance and in reducing frailty among community-dwelling adults aged ≥65 years compared to usual care. Secondary objectives include evaluating its impact on pain, anxiety or depression, sleep quality, quality of life, physical activity, handgrip strength, and polypharmacy. A double-blind, randomized, parallel-group controlled trial will be conducted in primary care centers in Lleida. Frail older adults (≥65 years) will be recruited and randomly allocated to either the intervention group, receiving a structured cognitive-motor dual-task based multicomponent program, or the control group, receiving usual care. Outcomes will be assessed using validated tools at baseline and follow-up.

Participants needed: 220
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: Universitat de LleidaUpdated: Oct 3, 2025
Eligibility criteria

Aged 65 or older [+4]

Decompensated / Unstable cardiovascular disease or recent diagnosed [+5]

Status: Recruiting

Frailty in Hip or Knee Arthroplasty Patients.

The study aims to understand the existing differences between frail and non-frail subjects who underwent a rehabilitation path after receiving hip or knee arthroplasty surgery.

Participants needed: 124
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Joel PolletUpdated: Jul 25, 2025Locations: 1
Eligibility criteria

Received elective hip or knee arthroplasty; [+2]

Arthroplasty revision or not elective intervention; [+2]

Status: Recruiting

Applying a Multidisciplinary Intervention for Drug Adequacy in an Intermediate Care Hospital (AMIDA-ICH)

The goal of this clinical trial is to learn if a multi-professional (conducted by geriatricians, clinical pharmacists, nurses) medication revision, centered on patients' goals and characteristics, can improve treatment adequacy in older adults admitted to an intermediate care hospital. The main question it aims to answer is: does this approach reduce the average number of medications taken per patient? Researchers will compare this multi-professional patient-centered revision to the usual standard of care (treatment revision conducted by a clinical pharmacist) to see if the patient-centered revision works in improving treatment adequacy. Participants admitted to an intermediate care hospital will undergo a comprehensive assessment by a geriatrician, and a medication revision (conducted by a multidisciplinary team or a clinical-pharmacist alone). They will also be asked to fulfill some questionnaires on their health status and attitudes. Any possible adverse events to the medications will be recorded at discharge. Participants will be contacted again three months after discharge to check for any readmission or death.

Participants needed: 300
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: Parc Sanitari Pere VirgiliUpdated: Jun 11, 2025Locations: 1
Eligibility criteria

older adults (65+ years) [+3]

unable to provide informed consent [+4]

Status: Recruiting

Effect of Modified Poco-Poco Exercise to Frailty Stages, Expression of Global DNA Methylation, GDF15 and Lamin A COP

The goal of this clinical trial is to know the effect of multicomponent exercise in frail elderly in community to aging hallmarks. The main question\[s\] it aims to answer are: 1. Do global DNA methylation levels change in elderly people in Bandung after receiving modified poco-poco exercise? 2. Do GDF15 levels change in elderly people in Bandung after they are given modified poco-poco exercise? 3. Do lamin A COP levels change in elderly people in Bandung after they are given modified poco-poco exercise? 4. Does the level of frailty in elderly people in Bandung change after they are given modified poco-poco exercise? Participants will be asked to do flexibility, balance, aerobic and strengthening exercise included in poco-poco modified exercise three times a week for 12 weeks

Participants needed: 17
Trial details
Age: 60+Biological sex: AllType: InterventionalSponsor: Universitas PadjadjaranUpdated: Mar 4, 2025Locations: 1
Eligibility criteria

Frailty level is in pre-frailty [+3]

There is a hearing impairment that may prevent the subject from receiving verbal... [+8]

Status: Recruiting

Video Decision Support for Advance Care Planning in Geriatric Patients With Frailty

As the proportion of the aging population continues to rise, age-related frailty syndrome, characterized by a decline in the function of multiple physiological systems and accompanied by vulnerability to stress, has become a significant issue. It has been associated with higher mortality rates, hospitalization rates, risk of falls, occurrence of fractures, decreased mobility, depression, cognitive decline, dementia, loneliness, and admission to long-term care facilities. Advance care planning is a thoughtful and communicative process that helps individuals, while still cognitively capable, to pre-determine and express their preferences for medical care in the event of future incapacity. With the ongoing development in the field of frailty and the rapid aging of the population, the increasing age may be accompanied by severe illnesses, symptom burden, functional dependence, caregiver burden, and extensive medical utilization. The importance of advance care planning is increasingly emphasized, but its implementation and promotion remain challenging. In addition to systematic promotion from a policy perspective, tools to assist patients in decision-making have been proposed. Video decision aids can encourage people to engage in advance care planning by sparking conversations about informed consent and helping individuals contemplate the choices they may face. Video decision aids can also assist individuals in envisioning future scenarios and reflecting on their decisions. Previous randomized controlled trials have explored the benefits of such video tools for specific patient populations, such as cancer patients, heart failure patients, and elderly individuals hospitalized. However, there is a need for innovative approaches to enhance the knowledge, willingness, and actual signing rates of advance care planning for frail elderly individuals. This study aims to develop a video decision aid specifically tailored for the elderly frail population undergoing advance care planning. Through a randomized controlled trial, the study aims to validate its actual benefits, expecting to assist the elderly frail population in understanding and expressing their willingness for advance care planning, increasing the actual willingness to sign advance directives, and helping clinical healthcare teams achieve person-centered, high-quality care for this population.

Participants needed: 96
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: National Taiwan University HospitalUpdated: Nov 21, 2024Locations: 1
Eligibility criteria

age > or = 65 y/o can communicate and sign informed consent diagnosed to be frai...

impaired visual acuity or hearing that can't watch video had signed advance deci...

Status: Recruiting

Advanced Practice Nurses for Fall Incidence PrevenTion in Very Old Robust Adults

APN-FIT is a hybrid type 1 clinical trial comparing the effect of an APN delivered fall prevention programme with standard care in non-frail patients. All participants will receive a full geriatric assessment at enrolment and, on a voluntary basis, physical activity programmes during the 12-month period. Falls occurring during the study will be recorded at 2, 4, 6, 8, 10 and 12 months after enrolment. An ancillary study will specifically examine implementation outcomes of the tested intervention.

Participants needed: 386
Trial details
Age: 80+Biological sex: AllType: InterventionalSponsor: Nantes University HospitalUpdated: Nov 15, 2024Locations: 1
Eligibility criteria

Aged 80 or over; [+4]

Under guardianship or trusteeship; [+2]

Status: Recruiting

Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation

The final goal of the present study is to propose a new approach in the Parkinson's Disease rehabilitation, focused on the use of robotic devices and to check the results not only at the end of the treatment but also in the long term, foreseeing 3 follow-up.

Participants needed: 195
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: Istituto Nazionale di Ricovero e Cura per AnzianiUpdated: Oct 23, 2023Locations: 2
Eligibility criteria

Hoen and Yahr scale: 1-3 stage [+4]

Concomitant participation in other studies [+8]