Feasibility Studies

BackgroundSarcopenia leads to functional disability, dependence in activities of daily living (ADL), and is a key contributor to frailty. Reducing and breaking up sedentary time is associated with improved sarcopenia and frailty-related outcomes. The aim of this study was to determine the feasibility of delivering and evaluating a remote sedentary behaviour intervention to improve sarcopenia and independent living in older adults with frailty.MethodsA two-arm randomised controlled feasibility trial was conducted with a target of 60 older adults (mean age 74 ± 6 years) with very mild or mild frailty. Participants were randomised to the Frail-LESS (LEss Sitting and Sarcopenia in Frail older adults) intervention or usual care control group for six months. The intervention included tailored feedback on sitting, standing and stepping; an education workbook that included goal setting and action planning; one-to-one health coaching; peer support; and a wearable device to self-monitor sedentary behaviour. Participant recruitment (percentage of eligible individuals recruited), retention and data completion rates were used to assess trial feasibility. Acceptability of the trial was explored through interviews and safety was evaluated via unplanned healthcare utilisation and number of falls. Sitting, standing, stepping and sarcopenia were measured to evaluate potential intervention effects.ResultsSixty participants were recruited. Recruitment and retention rates were 72% and 83%, respectively. Completion rates for outcome measures ranged from 70 to 100%. The trial was safe (ConclusionsThis study demonstrates the feasibility and safety of delivering and evaluating a remote intervention to reduce and break up sitting in older adults with frailty. The intervention showed evidence towards reducing daily sitting and improving sarcopenia, supporting its evaluation in a definitive randomised controlled trial.Trial registrationISRCTN registry (registration number: ISRCTN17158017). Registered 6th August 2021.

BackgroundThe Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) multimodal lifestyle intervention yielded cognitive and other health benefits in older adults at risk of cognitive decline. The two-year multinational randomized controlled LETHE trial evaluates the feasibility of a digitally supported, adapted FINGER intervention among at-risk older adults. Technology is used to complement in-person activities, streamline the intervention delivery, personalize recommendations, and collect digital biomarkers.MethodsTrial includes older adults (60-77 years) with digital readiness/experience with smart devices and increased dementia risk but without substantial cognitive impairment. Participants are enrolled at four sites (Austria, Finland, Italy, Sweden). At baseline, participants were randomized 1:1 ratio to 1) intervention i.e., structured multimodal lifestyle program (including diet, exercise, cognitive training, vascular/metabolic risk management, social stimulation, sleep/stress management) where in-person activities led by professionals are supported with an Android mobile phone application developed by the consortium (the LETHE App); or 2) control i.e., self-guided program (regular health advice; simplified App with no personalized/interactive content). All participants wear smartwatches to gather passive data (e.g., physical activity, sleep). Primary outcomes are retention, adherence, and change in validated dementia risk scores. Secondary outcomes include changes in lifestyle, cognition, stress, sleep, health-related quality of life, and health literacy. Additional outcomes (exploratory) include e.g. participant experiences and dementia-related biomarkers (Alzheimer's disease blood markers, neuroimaging). A sub-study explores the feasibility of novel interactive technology (audio glasses, social robot).ResultsRecruitment began in September 2022, and the last participant was randomized in June 2023. In total, 156 individuals were randomized (mean age 69 years, 65% women; balanced recruitment across the four sites). Vascular and lifestyle risk factors were common (e.g., 65% with hypertension, 69% with hypercholesterolemia, 39% physically inactive), indicating successful recruitment of a population with risk reduction potential. Trial will be completed by summer 2025. Retention until the first post-baseline visit at 6 months is high (n = 2 discontinued, retention 98.7%).ConclusionLETHE provides crucial information about the feasibility of technology and a digitally supported FINGER lifestyle program to promote brain health. Digital tools specifically designed for older adults could offer potential for large-scale, cost-effective prevention programs.Trial registrationClinicalTrials.gov (NCT05565170).

BackgroundFrailty leads to reduced physical activity can cause increased fall risk. This contributes to accelerated aging processes, leading to adverse health outcomes and reduced quality of life. We have developed and piloted the design, usability, safety, and feasibility of a gaming-based cognitive-motor (CogXergaming) tele-exercise protocol in prefrail older adults.ObjectiveThis pilot randomized control trial tested preliminary feasibility and effectiveness of the CogXergaming telehealth protocol for improving physical function.MethodsCommunity-dwelling, prefrail older adults were randomly assigned to CogXergaming (n=13) or a control group (n=14). The CogXergaming group received supervised tele-exercises in a gaming format for 6 weeks (3 sessions per week) comprising 18 sessions lasting 90 minutes each. Control group participants participated in a Matter of Balance (MOB), an 8-week, once-a-week structured 90-minute tele-session that has been shown to reduce the fear of falling and increase physical activity. Feasibility of training was obtained by computing the median duration of training sessions for the CogXergaming group. Effectiveness was assessed using dynamic balance control (Four Square Step Test), subjective self-efficacy (Activities-Specific Balance Confidence scale), gait function (Tinetti Performance Oriented Mobility Assessment), muscle strength (30-second chair stand test), and endurance (2-minute step in-place test).ResultsOf the 45 participants enrolled in the study, 4 participants from CogXergaming group and 5 from MOB group lost contact after signing the consent form and did not receive their respective intervention. Eighteen participants were randomized to each group. In the CogXergaming group, 15 (83%) completed the intervention, with 3 (16%) dropping out in the first week. In the MOB group, 16 (88%) completed the program, with 2 (11%) withdrawing during the first week. In addition, there was a significant time group interaction for Four Square Step Test (F1,21=5.55, P=.03), Tinetti Performance Oriented Mobility Assessment (F1,25=4.16, P=.05), and 30-second chair stand test (F1,21=5.06, P=.03), with a significant improvement in these measures for the CogXergaming group post training, compared with no change observed in the MOB group.ConclusionsThese pilot findings indicate that CogXergaming is feasible and applicable in prefrail older adults. Such game-based protocols can be beneficial in improving physical function among community-dwelling, prefrail older adults, however, the efficacy of such training requires further investigation.Trial registrationClinicalTrials.gov NCT04534686; https://clinicaltrials.gov/study/NCT04534686.

BackgroundPatients undergoing surgery often experience stress and anxiety, which can increase complications and hinder recovery. Effective management of these psychological factors is key to improving outcomes. Preoperative anxiety is inversely correlated with the amount of information patients receive, but accessible, personalized support remains limited, especially in preoperative settings. Face-to-face education is often impractical due to resource constraints. Digital health (DH) interventions offer a promising alternative, enhancing patient engagement and empowerment. However, most current tools focus on providing information, overlooking the importance of personalization and psychological support.ObjectiveThis study aimed to assess the viability of a DH intervention known as the Adhera CARINAE DH Program. This program is specifically designed to offer evidence-based and personalized stress- and anxiety-management techniques. It achieves this by using a comprehensive digital ecosystem that incorporates wearable devices, mobile apps, and virtual reality technologies. The intervention program also makes use of advanced data-driven techniques to deliver tailored patient education and lifestyle support.MethodsA total of 74 patients scheduled for surgery across 4 hospitals in 3 European countries were enrolled in this study from September 2021 to March 2022. Surgeries included cardiopulmonary and coronary artery bypass surgeries, cardiac valve replacements, prostate or bladder cancer surgeries, hip and knee replacements, maxillofacial surgery, and scoliosis procedures. After assessment for eligibility, participants were randomized into 2 groups: the intervention group (n=23) received the Adhera CARINAE DH intervention in addition to standard care, while the control group (n=27) received standard care alone. Psychological metrics such as self-efficacy, self-management, and mental well-being were assessed before and after the intervention, alongside physiological markers of stress.ResultsThe intervention group demonstrated significant improvements across several psychological outcomes. For example, Visual Analogue Scale Stress at the hospital improved at admission by 5% and at hospital discharge by 11.1% and Visual Analogue Scale Pain at admission improved by 31.2%. In addition, Hospital Anxiety and Depression Scale Anxiety after surgery improved by 15.6%, and Positive and Negative Affect Scale-Negative at hospital admission improved by 17.5%. Overall, patients in the intervention study spent 17.12% less days in the hospital. Besides these individual scores, the intervention group shows more positive relationships among the psychological dimensions of self-efficacy, self-management, and mental well-being, suggesting that the CARINAE solution could have a positive effect and impact on the reduction of stress and negative emotions.ConclusionsOur results provide an important first step toward a deeper understanding of optimizing DH solutions to support patients undergoing surgery and for potential applications in remote patient monitoring and communication.Trial registrationClinicalTrials.gov NCT05184725; https://clinicaltrials.gov/study/NCT05184725.International registered report identifier (irrid)RR2-10.2196/38536.