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Clinical trials for Alzheimer's disease (AD) are slower to enroll study participants, take longer to complete, and are more expensive than trials in most other therapeutic areas. The recruitment and retention of a large number of qualified, diverse volunteers to participate in clinical research studies remain among the key barriers to the successful completion of AD clinical trials. An advisory panel of experts from academia, patient-advocacy organizations, philanthropy, non-profit, government, and industry convened in 2020 to assess the critical challenges facing recruitment in Alzheimer's clinical trials and develop a set of recommendations to overcome them. This paper briefly reviews existing challenges in AD clinical research and discusses the feasibility and implications of the panel's recommendations for actionable and inclusive solutions to accelerate the development of novel therapies for AD.
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Enfermedad de Alzheimer , Humanos , Enfermedad de Alzheimer/tratamiento farmacológico , Selección de PacienteRESUMEN
BACKGROUND: Pressure injuries are one of the most challenging secondary conditions for individuals with spinal cord injuries and related disorders (SCI/D) owing to inherent, lifelong risk factors that include a lack of sensory and motor function below the level of injury and reliance on a wheelchair for daily mobility, resulting in prolonged periods of sitting. Although many factors contribute to the development of pressure injuries, the pressure between the skin and a surface is always a factor and the development of injury is dependent on the magnitude and duration of the pressure. Clinically, broad recommendations for relieving pressure are used because we know very little about the unique day-to-day life patterns of the individual wheelchair user. Typically, it is after the occurrence of a pressure injury that the therapist will check equipment fit and the effectiveness of pressure offloading and ask about other surfaces they sit on in their home and community. This time-lapsed, largely self-reported data are fraught with recall bias and inaccuracies that the therapist incorporates into a plan of care. OBJECTIVE: This study's objective is to pilot-test the implementation and clinical effectiveness of a telehealth model of care combined with our mobile health (mHealth) Assisted Weight-Shift device for remote monitoring of factors related to maintaining skin health and wheelchair setup. Our overall hypothesis is that this study will result in an effective implementation plan, and the enhanced connected model of care using remote monitoring of pressure management will result in pilot-level, improved clinical outcomes for adults with spinal cord injury at high risk for pressure injury recurrence. METHODS: For all aims, we will use a mixed methods design using an exploratory, sequential approach to include the strengths of both qualitative and quantitative data. For aims 1 and 2, we will iteratively collect qualitative data from therapists, patients with SCI/D, and other stakeholders. For aim 3, we will perform a hybrid effectiveness-implementation randomized controlled trial to pilot-test the intervention. The projected results include an iteratively developed and tested implementation plan that meets moderate to high levels of acceptability, feasibility, and appropriateness. Additionally, the pilot trial results are expected to show positive trends in relevant clinical outcomes related to reduced pressure injury incidence, recurrence, and improved healing when compared with the standard of care. RESULTS: Currently, 6 participants have been recruited for our aim-1 qualitative study. CONCLUSIONS: This study will expand upon our previous study to move the Assisted Weight-Shift system into routine clinical care, which was a strong desire of adults with SCI/D for improved individualized care plans to prevent pressure injuries. The results of this study will guide the next steps in a full, hybrid effectiveness-implementation trial with the goal of improving care to prevent pressure injuries. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/51849.
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BACKGROUND AND PURPOSE: Thoracic hyperkyphosis is a common condition that progresses with aging and has been associated with impaired functional performance, increased risk of falls, and even mortality. Previous studies to improve posture primarily used exercise for durations of 3 months or longer. The purpose of this pilot study was to examine the feasibility of a manual therapy intervention in community-dwelling older adults over a 4-week time frame that is comparable to the typical clinical setting, to test the appropriateness and procedures for the measurement of posture and function in the older population with hyperkyphosis, and to collect preliminary data to describe change in posture and function measures. METHODS: Twenty-four participants with hyperkyphosis or forward head posture were recruited, and 22 participants completed this pilot study. Feasibility was measured based on attendance, tolerance, safety, and retention. Issues with measurement procedures were recorded. The intervention included manual therapy and exercise 3 times a week for 4 weeks to target spinal and peripheral joint stiffness, muscle lengthening, and muscle activation. Outcomes included height, kyphotic index (KI), Block Test, Acromion to Table (ATT), Timed Up and Go (TUG), 5 times sit-to-stand (5XSTS), Functional Reach (FR), 2-minute walk test (2MWT), and Patient-Specific Functional Scale (PSFS). Data collected at visits 1, 6, and 12 were analyzed using 1-way repeated-measures multivariate analysis of variance. RESULTS AND DISCUSSION: Measurement and intervention protocols were found to be feasible. A significant effect for the aggregate dependent variables change over time was found. Univariate analysis of each dependent variable showed significance except for FR. All postural measures (height, KI, Block Test, and ATT) significantly improved statistically. The KI and ATT exceed the minimal detectable change for clinical significance. Function showed statistical improvements in the TUG, 5XSTS, 2MWT, and PSFS. Clinical significance was reached with the PSFS. Seven of 9 measures showed a statistically significant change in just 2 weeks. CONCLUSIONS: This pilot study suggests that manual therapy and exercise applied to older adults shows promise for improvement in measures of posture and functional performance in a clinically feasible 4-week time frame.
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Cifosis , Manipulaciones Musculoesqueléticas , Humanos , Anciano , Terapia por Ejercicio/métodos , Proyectos Piloto , Vida Independiente , Estudios de Factibilidad , Postura/fisiología , Equilibrio Postural/fisiologíaRESUMEN
The administration of lithium chloride (LiCl) for cardiac output (CO) measurement via a peripheral instead of a central vein has been described previously as a valid alternative route in pigs and dogs. The aim of the study was to compare CO measurements after administration of LiCl using two peripheral veins, cephalic or jugular, in goats. Ten adult, female, experimental goats undergoing bilateral stifle arthrotomy were recruited for the study. Paired CO measurements were taken two minutes apart during stable conditions in isoflurane-anaesthetised goats. Forty-two paired CO measurements were taken in total, and the median (range) of paired CO measurement per goat were 4.5 (3-6). The mean (SD) CO using the cephalic and jugular vein for injection of LiCl was 5.28 (1.29) L min-1 and 5.20 (1.24) L min-1 respectively. The Bland-Altman analysis showed an acceptable agreement with a mean bias of 1.33% with limits of agreement (LoA) of -18.43 to 21.09%. The percentage of error was 25%. The four-quadrant plot analysis showed a poor agreement (71%) between the two routes. The polar plot showed a poor trending ability. An 86% inclusion rate (18/21 points) was reached with a ± 35° radial sector size. The findings revealed that the agreement between the two routes is not as precise as the authors expected, however the results are comparable with studies published previously.
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Isoflurano , Termodilución , Animales , Gasto Cardíaco , Perros , Femenino , Cabras , Litio , Cloruro de Litio , Porcinos , Termodilución/veterinariaRESUMEN
BACKGROUND AND PURPOSE: The purpose of this study was to identify the effects of a corrective exercise for thoracic hyperkyphosis on posture, balance, and well-being in Korean community-dwelling older women. METHODS: Fifty women 65 years of age and older, recruited from 2 senior centers, participated in this study. Participants were assigned to either the experimental group (EG) or the control group (CG) on the basis of convenience of location, and 22 in each were analyzed. Participants in the EG underwent a thoracic corrective exercise program 1 hour each session, twice per week for 8 weeks (a total of 16 sessions), which consisted of specific exercises to enhance breathing, thoracic mobility and stability, and awareness of thoracic alignment. The CG received education on the same thoracic corrective exercise program and a booklet of the exercises. Outcome measures included the extent of postural abnormality (angle of thoracic kyphosis, kyphosis index calculated both in relaxed- and best posture using flexicurve, the ratio of the kyphosis index calculated best posture/relaxed posture, craniovertebral angle, and tragus-to-wall distance), balance (Short Physical Performance Battery and limit of stability), and well-being (Geriatric Depression Scale Short Form and the 36-Item Short Form Health Survey [SF-36]). All data were collected by 6 blinded assessors at baseline, at 8 weeks after the completion of intervention, and at 16 weeks for follow-up. RESULTS AND DISCUSSION: For participants of the EG, means of all parameters showed significant improvements over time (P < .05), with improved values both in comparison of baseline to postintervention and baseline to follow-up. Means of CG parameters were significantly improved in only the angle of thoracic kyphosis and the tragus-to-wall distance (P < .05). Furthermore, in all parameters, percent change between baseline and postintervention data was significantly (P < .05) higher for the EG than that for the CG, except for the limit of stability and SF-36 which improved but not significantly. All parameters between baseline and follow-up data were significantly (P < .05) higher for the EG than those for the CG, except for the limit of stability. CONCLUSIONS: The findings of this study suggest that a well-designed exercise program may be beneficial to improve spinal posture, balance, and well-being in older women with thoracic hyperkyphosis. We recommend the use of the therapeutic strategies utilized in this study to enhance thoracic posture, balance, and well-being of older women with thoracic hyperkyphosis. Future research is needed to apply this exercise protocol on a larger and more diverse population.
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Terapia por Ejercicio/métodos , Cifosis/rehabilitación , Anciano , Anciano de 80 o más Años , Método Doble Ciego , Femenino , Estado de Salud , Humanos , Vida Independiente , Salud Mental , Equilibrio Postural , Postura , Rango del Movimiento ArticularRESUMEN
OBJECTIVE: To determine the factors impacting the decisions of student physical therapists (PTs) and physical therapist assistants (PTAs) to join and maintain membership in the American Physical Therapy Association and the Texas Physical Therapy Association, in light of a membership initiative of Reach 100 that was adopted in Texas. STUDY DESIGN: Survey, descriptive. METHODS: An online membership survey invitation was distributed to Texas PT and PTA students. RESULTS: A total of 479 students responded to the survey. A majority of participants (67%) reported being members, while 33% reported being non-members. The primary reason students (74%) reported for being a member was that they were encouraged by their academic program. Students who are not members (87%) cited the high cost of national dues. A majority of participants (n=379, 83%) rated faculty promotion of membership as somewhat high to high. In contrast, only 26% rated the promotion of membership by their clinical education sites as somewhat high to high. Professional growth and development was cited as the main reason to maintain membership. CONCLUSIONS: Although students are being encouraged to join, a third of the respondents still do not belong. It is imperative that clinical mentors model and support membership activities. Association leadership may use this information to develop strategic plans to be inclusive of the student and new professional.
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Especialidad de Fisioterapia , Sociedades Médicas , Estudiantes , Adulto , Docentes , Femenino , Humanos , Masculino , Mentores , Encuestas y Cuestionarios , Texas , Adulto JovenRESUMEN
The first wave of NHS walk-in centres opened in 2000. Since then, a total of 57 centres have opened in England with 25 more planned in the next few months. These centres do not aim to replace existing primary or secondary care services but to complement them and provide the public with an alternative means of accessing health care for minor illnesses, minor injuries and emergency contraception. Two models of walk-in centre exist: those based in primary care and those based in secondary care.
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Instituciones de Atención Ambulatoria/organización & administración , Modelos Organizacionales , Educación del Paciente como Asunto/organización & administración , Atención Primaria de Salud/organización & administración , Humanos , Enfermeras Practicantes , Rol de la Enfermera , Evaluación en Enfermería/métodos , Estudios de Casos Organizacionales , Educación del Paciente como Asunto/métodos , Atención Primaria de Salud/métodos , Medicina Estatal/organización & administración , Reino UnidoRESUMEN
BACKGROUND: The impact of walking speed has not been evaluated as a feasible outcome measure associated with peak plantar pressure (PPP) distribution, which may result in tissue damage in persons with diabetic foot complications. The objective of this pilot study was to determine the walking speed and PPP distribution during barefoot walking in persons with diabetes. METHODS: Nine individuals with diabetes and nine age-gender matched individuals without diabetes participated in this study. Each individual was marked at 10 anatomical landmarks for vibration and tactile pressure sensation tests to determine the severity of sensory deficits on the plantar surface of the dominant limb foot. A steady state walking speed, PPP, the fore and rear foot (F/R) PPP ratio and gait variables were measured during barefoot walking. RESULTS: Persons with diabetes had a significantly slower walking speed than the age-gender matched group resulting in a significant reduction of PPP at the F/R foot during barefoot walking (p < 0.05). There was no significant difference in F/R foot PPP ratio in the diabetic group compared with the age-gender matched group during barefoot walking (p > 0.05). There was a significant difference between the diabetic and non-diabetic groups for cadence, step time, toe out angle and the anterior-posterior excursion (APE) for centre of force (p < 0.05). CONCLUSION: Walking speed may be a potential indicator for persons with diabetes to identify PPP distribution during barefoot walking in a diabetic foot. However, the diabetic group demonstrated a more cautious walking pattern than the age-gender matched group by decreasing cadence, step length and APE, and increasing step time and toe in/out angle. People with diabetes may reduce the risk of foot ulcerations as long as they are able to prevent severe foot deformities such as callus, hammer toe or charcot foot.
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Pie Diabético/fisiopatología , Caminata/fisiología , Anciano , Fenómenos Biomecánicos/fisiología , Estudios Transversales , Femenino , Marcha/fisiología , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , PresiónRESUMEN
PURPOSE: The purpose of this study was to determine the issues and perceptions of persons newly diagnosed (within last 3 months) with type 2 diabetes. METHODS: In this qualitative study, 16 adults newly diagnosed with type 2 diabetes were recruited, who completed a demographic, lifestyle, and diabetes management questionnaire and then were interviewed using cognitive mapping. Participants were asked to write words or phrases that came to mind when thinking about living with diabetes. From these words, common concepts were identified, grouped into clusters, and reduced into categories. Associations were sought between demographics and categories. RESULTS: A total of 260 Post-It notes were written, from which 123 concepts were identified and grouped into 24 clusters. The most frequent concept was eat, and the 3 most frequent clusters were food, negative emotions, and diabetes and its complications. The 9 categories, in order of frequency, were as follows: (1) need to (self-management), (2) concerns, (3) "I'm sick", (4) emotional distress, (5) loss, (6) the no's (limitations), (7) fears and complications, (8) have to (medical management), and (9) coping. Persons with a college education and a later interview date since diagnosis were associated with the concepts in the need to and have to categories. Concepts in the I'm sick category were associated with lower income and Hispanic ethnicity. CONCLUSIONS: Diabetes educators should consider this holistic representation of the issues and perceptions reflected in the common concepts, clusters, and categories expressed by persons newly diagnosed with diabetes.
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Cognición , Formación de Concepto , Diabetes Mellitus Tipo 2/psicología , Emociones , Hispánicos o Latinos , Autocuidado/psicología , Población Blanca , Adaptación Psicológica , Adulto , Anciano , Ansiedad/etnología , Ansiedad/etiología , Diabetes Mellitus Tipo 2/epidemiología , Diabetes Mellitus Tipo 2/etnología , Femenino , Grupos Focales , Conocimientos, Actitudes y Práctica en Salud , Humanos , Masculino , Persona de Mediana Edad , Educación del Paciente como Asunto , Relaciones Profesional-Paciente , Psicometría , Investigación Cualitativa , Autocuidado/estadística & datos numéricos , Clase Social , Encuestas y Cuestionarios , Texas/epidemiologíaRESUMEN
Three young grey seals (Halichoerus grypus) were presented separately for fracture repair to the veterinary teaching hospital of University College Dublin. The seals were premedicated with a combination of pethidine, midazolam and atropine; anaesthesia was induced with propofol via the front flipper vein and maintained with sevoflurane or isoflurane in oxygen. One of the seals did not breathe spontaneously after anaesthesia; a cardiac arrest, resulting in death, occurred after several hours of mechanical ventilation. Post-mortem examination revealed a severe lungworm infestation and parasitic pneumonia in this animal. The two other seals recovered uneventfully from anaesthesia.