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Frail status reflects increased vulnerability to stressors due to diminished physiological reserves, often observed in older adults but not limited by age. Clinical trials involving frail individuals explore approaches to improve quality of life, pre...

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Found 548 Actively Recruiting clinical trials

A

Actively Recruiting

Researchers are evaluating the AGIL Barcelona program to help frail older adults improve their physical abilities and delay disability. This study focuses on adapting and expanding the program across different community health centers in Barcelona. It aims to measure improvements in physical performance using a simple test SPPB and assess how well the program can be implemented in various neighborhoods. The program includes up to 10 weekly group exercise sessions led by a physiotherapist, emphasizing strength, balance, flexibility, and endurance. Participants receive personalized exercises supported by easy-to-understand materials. The program also offers advice on healthy habits like the Mediterranean diet, sleep improvement, and managing swallowing or memory issues. Medication reviews are conducted to ensure safe and appropriate treatments, and support is provided to connect participants with local activities to reduce social isolation. Participants will be involved in assessments of their physical performance, quality of life, cognitive function, social engagement, diet adherence, medication use, and any adverse events at the start, three months, and six months. The study uses a stepped approach to introduce the program at different sites gradually. Researchers will also gather qualitative feedback on participants experiences and program implementation. The total participation duration includes baseline and follow-up visits over six months.

Age: 65Years +All GendersPhase Not Applicable
3 locations
Y

Actively Recruiting

Healthy Volunteer

The 100-Year Human Aging Study is a long-term observational research project enrolling adult participants to undergo detailed multi-system health screenings and follow them throughout their lives until death. The study aims to identify which health measurements taken at enrollment and repeatedly over time can predict overall mortality, cause-specific death, serious diseases, and functional disability. It addresses the current lack of validated longevity measures by generating data on how various physiological and cognitive functions relate to aging outcomes. Participants undergo a comprehensive clinical screening that includes tests of cardiorespiratory fitness, strength, mobility, neurocognitive performance, sensory functions, and metabolic health. Structural imaging assessments like DEXA scans, echocardiography, electrocardiography, spirometry, retinal photography, and vascular ultrasound are performed. Laboratory tests and detailed medical, social, and environmental histories are also collected. The study allows participation from single tests up to a full two-visit screening, with repeat testing encouraged to track health changes over time. Throughout the study, participants receive individualized reports with investigational estimates of biological age and predicted mortality risks, which are being evaluated against actual health outcomes. Researchers collect data continuously on mortality, disease occurrence, disability, and health behavior changes. The study involves ongoing follow-up with periodic assessments and aims to preserve all collected data for future analyses, with participant involvement potentially spanning their entire lifespan.

Age: 18Years +All Genders
1 location
B

Actively Recruiting

Healthy Volunteer

Bipolar disorder BD is a serious mental illness that tends to run in families and affects behavior, thinking, emotions, social interactions, and work. It has characteristics like high prevalence, frequent recurrence, and early onset. Early recognition and diagnosis are challenging but important for better outcomes. This research aims to create a large, high-quality group of BD high-risk individuals by enrolling 400 participants over four years and following them intensively for ten years using an electronic mental health platform. The study will collect various types of data including clinical, genetic, cognitive, neuroimaging, sleep, EEG, eye movement, speech, facial expression, and movement to understand how biological, clinical, and environmental factors interact in BD onset. The study is observational and includes three groups children aged 6 to 18 who have at least one parent with BD, children with atypical depression diagnosed by DSM-5 criteria, and healthy children matched by age and gender without psychiatric family history. Participants will be assessed yearly for four years, including brain scans and multiple follow-ups to track the development of mental illnesses, brain structure and function, cognitive function, sleep quality, quality of life, and genetic features. Participants will be involved in annual evaluations for four years, including clinical assessments and brain imaging. Researchers will monitor the differences in development among the three groups over time. The main outcomes focus on the prevalence of mental illness, brain development, and multi-modal feature changes. Secondary outcomes include cognitive function, sleep quality, quality of life, and genetic differences. This long-term follow-up aims to develop predictive models for BD onset and guide early, personalized interventions for those at high risk.

Age: 6Years - 18YearsAll Genders
1 location
E

Actively Recruiting

Healthy Volunteer

Researchers are evaluating how a combined program of aerobic and resistance exercises along with cognitive training affects brain function in older adults aged 60 and above. The study focuses on people who are sedentary and may or may not have cardiovascular risk factors like diabetes, high blood pressure, or high cholesterol, conditions known to impact memory and attention. This trial aims to compare the effects of physical exercise alone versus combined physical and cognitive training on thinking skills and brain health. The trial includes three groups one group will do both cognitive and physical training, another will do only aerobic and resistance exercises, and the third group will perform stretching and toning exercises as an active control. Each group participates in three sessions per week for 46 weeks, with options to train at home or at a center. The physical exercise sessions include warm-up, moderate to vigorous aerobic activity monitored by heart rate, and resistance training, while cognitive training involves computer-based memory and attention tasks. Participants will undergo assessments at the start and after 12 months to measure changes in general cognition, processing speed, executive functions, and memory. Brain imaging and blood flow measures will also be evaluated to observe changes in brain structure and function. Throughout the study, participants will be monitored for exercise intensity and adherence. The total study duration covers 12 months, with safety and cognitive outcomes closely tracked to understand the impact of these interventions.

Age: 60Years +All GendersPhase Not Applicable
1 location
C

Actively Recruiting

Researchers are evaluating the use of a high protein egg white pudding as a nutritional supplement for people with kidney failure who are on dialysis. The study aims to find out if giving this egg white pudding after dialysis is practical and whether it can improve blood protein levels, frailty, dietary intake, and other blood markers compared to a standard supplement called Ensure Plus. This trial is conducted by Seven Oaks Hospital Chronic Disease Innovation Centre. Participants will be randomly assigned to receive either the egg white protein pudding or Ensure Plus at the end of their dialysis treatments three times a week for 12 weeks. Both supplements are dietary and taken during the dialysis sessions. The study collects data during this 12-week intervention period to evaluate the effects of the two supplements. During the study, participants will be monitored for their ability to stay in the trial, adherence to the supplements, and health measures such as hand grip strength, walking speed, balance, and blood levels including serum albumin and electrolytes. These assessments occur at the end of the 12 weeks. The trial also tracks recruitment and follow-up rates to evaluate feasibility. Overall, participants are involved in regular supplement intake and health testing during dialysis over three months.

Age: 18Years +All GendersPhase Not Applicable
2 locations
N

Actively Recruiting

The global population of older adults is rapidly growing, with a significant increase in those aged 65 and over, especially in China. Frailty, a condition marked by reduced strength and function across multiple body systems, is common among the elderly and can lead to serious health issues such as falls, disability, hospitalization, and increased mortality. This trial aims to explore the characteristics and influencing factors of frailty in community-dwelling older adults in China, as well as to evaluate how nutritional and combined nutrition-exercise interventions affect frailty progression and management in this population. Participants will be randomly assigned to one of three groups for a 3-month intervention period followed by a 9-month follow-up. The first group receives a multifaceted nutrition intervention including anti-inflammatory dietary plans, personalized nutritional management with daily dietary tracking via WeChat, and biweekly health education sessions for participants and caregivers. The second group receives the same nutrition intervention combined with a structured exercise program conducted three times a week, featuring warm-up, aerobic, resistance strength, and relaxation training overseen by professional coaches. The control group will continue with routine community health management including chronic disease education, counseling, and health examinations. During the study, participants will undergo evaluations at baseline, after the 3-month intervention, and at 3, 6, and 12 months follow-up to assess physical performance using the Short Physical Performance Battery SPPB and frailty scores. Additional measures include assessments of frailty trajectories, nutritional risk, intrinsic capacity, quality of life, cognitive function, sleep quality, serum protein and inflammatory markers, and adverse events. Data will be collected via validated questionnaires, clinical exams, and laboratory tests to understand the sustainability and impact of the interventions over time.

Age: 65Years - 85YearsAll GendersPhase Not Applicable
1 location
E

Actively Recruiting

Researchers are investigating how a combination of brain stimulation and aerobic exercise can improve thinking skills, mobility, and brain function in older adults with cognitive frailty. This trial compares different types of theta burst stimulation, including intermittent theta burst stimulation iTBS primed with continuous theta burst stimulation cTBS, non-priming iTBS, and sham stimulation, to understand their effects on brain structure and function. The study aims to identify how these treatments impact cognition and movement and the brain mechanisms behind these changes. Participants will be randomly assigned to one of three groups receiving different theta burst stimulation protocols three times a week for three months cTBS followed by iTBS, sham cTBS followed by iTBS, or sham cTBS followed by sham iTBS. After each stimulation session, all participants will take part in 60-minute aerobic exercise sessions for a total of six months. The brain stimulation will be delivered using a special coil guided by MRI scans to target specific brain areas. During the study, participants will undergo tests at the start, three months, and six months to assess their cognitive abilities, mobility, and brain activity. These include memory and attention tests, physical performance measures like gait speed and balance, and brain imaging scans. Researchers will also monitor physical activity levels, mood, fatigue, and daily functioning. The total involvement includes 39 stimulation sessions and ongoing exercise, with comprehensive evaluations throughout the study period.

Age: 60Years - 90YearsAll GendersPhase Not Applicable
1 location
A

Actively Recruiting

Healthy Volunteer

This research investigates how aging affects motor control, focusing on healthy elderly individuals and patients with mild cognitive impairment. Researchers aim to understand differences in upper limb motor adaptation and to develop interventions that improve motor function and cognitive abilities through multisensory rhythmic skill training. The study also uses artificial intelligence to classify grasp patterns among young adults, elderly, and those with mild cognitive impairment. Participants are assigned to one of three groups virtual reality-based rhythmic skill training using VR headsets and controllers for 35 minutes, rhythmic skill training with visual feedback via a computer interface for 35 minutes, or an upper limb strengthening exercise program supervised by a therapist. These interventions include various exercises and sensory stimulations designed to enhance motor planning, execution, and cognitive processing. Throughout the study, participants undergo assessments at baseline, 8 weeks, and 16 weeks to measure changes in grip behavior, sensory perception, manual dexterity, and cognitive function using tests like the Mini-Mental Status Examination and Purdue pegboard test. Researchers monitor motor adaptation and cognitive improvements, with the overall goal of preserving independence and quality of life for the elderly. The study is randomized and double-blind, lasting up to 16 weeks.

Age: 18Years - 85YearsAll GendersPhase Not Applicable
1 location
I

Actively Recruiting

Maintaining the ability to perform daily activities is crucial for the quality of life, health, and independence of older adults. This research focuses on improving how functional impairments and frailty are identified and managed among older Veterans in primary care settings within the Veterans Health Administration VHA. The study aims to increase the use of standardized, low-burden tools to measure functional status, which has been challenging to implement widely due to the complexity of current methods. The initiative aligns with national VA priorities to support aging Veterans and improve healthcare planning. The study evaluates a patient-centered intervention called the PACT Function Initiative, which includes routine, standardized functional status measurement, nursing screening with primary care follow-up, electronic tools for documentation, educational sessions for staff, and tailored reports on functional status. Initially, all participating sites will use a standard bundle of implementation strategies such as champions and system-level audit and feedback. Sites with lower uptake after three months will be randomized to receive either continued standard implementation or an enhanced bundle that adds technical assistance and clinician-level audit and feedback. The study includes phases of pre-implementation, implementation, crossover allocation, and sustainment. Participants, who are older Veterans seen in VA primary care, will be part of assessments over 24 months. Researchers will measure changes in reach, clinical effectiveness, adoption, fidelity, patient experience, sustainability, and functional status using electronic health records and screening data. The study collects data at multiple time points to evaluate the impact of implementing the intervention. This ongoing monitoring will help inform strategies for better managing functional impairment and frailty in this population.

Age: 60Years +All GendersPhase Not Applicable
1 location
P

Actively Recruiting

Researchers are evaluating the effectiveness of a personalized prevention program PPP based on the Comprehensive Geriatric Assessment CGA for older adults with non-communicable chronic diseases NCDs. The study aims to reduce hospitalization rates and explore biological factors related to aging and frailty. This research involves 1216 participants recruited by General Practitioners GPs in Italy and focuses on the impact of the CGA in primary care settings. Participants are randomly assigned to two groups an intervention group that receives the PPP guided by the CGA and a control group receiving standard clinical care. The PPP includes assessments using the Brief-MPI scale covering motor, cognitive, nutritional, medication, vaccination, daily activities, and living situation domains. Participants in the intervention group receive brochures with tailored advice for 12 months, specialist referrals if needed, and provide saliva samples for biomarker analysis. The control group continues usual care without CGA evaluation or saliva collection. All participants will be monitored at baseline, 6 months, and 12 months with follow-up contacts to assess adherence, satisfaction, and health outcomes. Researchers will measure hospitalization rates as the primary outcome and secondary outcomes including combined health events, unplanned GP visits, and mortality rates. The study also collects data on psychological wellbeing and resilience. Statistical analyses will compare outcomes between groups over 12 months to assess the programs impact.

Age: 65Years +All GendersPhase Not Applicable
4 locations

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