Walk, Talk and Listen: a pilot randomised controlled trial targeting functional fitness and loneliness in older adults with hearing loss.

BACKGROUND: Age-related hearing loss (HL) is a prevalent disability associated with loneliness, isolation, declines in cognitive and physical function and premature mortality. Group audiological rehabilitation (GAR) and hearing technologies address communication and cognitive decline. However, the relationship between loneliness, physical function and GAR among older adults with HL has not been studied. OBJECTIVES: Explore the impact of a group exercise and socialisation/health education intervention and GAR on physical function and loneliness among older adults with HL. TRIAL DESIGN: A Young Men's Christian Association (YMCA)-based, 10-week, single-blind, pilot randomised controlled trial (RCT). PARTICIPANTS: Ambulatory adults aged 65 years or older with self-reported HL. INTERVENTIONS: Seventy-one participants were screened. Thirty-five were randomised to intervention (strength and resistance exercise, socialisation/health education) and GAR (hearing education, communication strategies, psychosocial support) or control (n=31): GAR only. OUTCOMES: Ninety-five per cent of eligible participants were randomised. GAR and exercise adherence rates were 80% and 85%, respectively. 88% of participants completed the study. Intervention group functional fitness improved significantly (gait speed: effect size: 0.57, 30 s Sit to Stand Test: effect size: 0.53). Significant improvements in emotional and social loneliness (effect size: 1.16) and hearing-related quality of life (effect size: 0.76) were related to GAR attendance and poorer baseline hearing-related quality of life. Forty-two per cent of participants increased social contacts outside the study. DISCUSSION: Walk, Talk and Listen was feasible and acceptable. Exercise and socialisation/health education improved loneliness and key fitness measures but provided no additional benefit to GAR only for loneliness. This is the first preliminary evidence about the benefits of exercise on fitness and GAR on loneliness among older adults with HL. IMPLICATIONS: This pilot trial provides key information on the sample size required for a larger, longer term RCT to determine the enduring effects of this holistic intervention addressing the negative psychosocial and musculoskeletal downstream effects of HL among older adults.

Targeting the psychosocial and functional fitness challenges of older adults with hearing loss: a participatory approach to adaptation of the walk and talk for your life program.

OBJECTIVE: Explore the acceptability of a socialisation, health education and falls prevention programme (Walk and Talk for Your Life: WTL) as an adjunct to group auditory rehabilitation (GAR) and how it might be adapted for older adults with hearing loss (HL). DESIGN: Content theme analysis (CTA) of guided interviews explored the experience of HL, the acceptability of a WTL programme and suggestions on how to adapt the WTL programme to better suit the needs of older adults with HL. STUDY SAMPLE: Twenty-eight (20 women, 8 men) adults (>55 years of age) with HL were interviewed. Seventeen had participated in past WTL programmes and eleven were sampled from the community. RESULTS: Interviewees reported difficulty socialising and a tendency to withdraw from social interactions. Addition of GAR to a WTL programme was found to be highly acceptable. Interviewees suggested that to best suit their needs, sessions should take place in a location with optimal acoustics; include small groups integrating hearing-impaired and hearing-intact participants; include appropriate speaking ground rules; and include an option for partner involvement. CONCLUSIONS: The adapted WTL programme provides a holistic and unique approach to the treatment of HL that has the potential to positively impact the hearing-impaired elderly.

Targeting functional fitness, hearing and health-related quality of life in older adults with hearing loss: Walk, Talk 'n' Listen, study protocol for a pilot randomized controlled trial.

BACKGROUND: Hearing loss (HL) is a disability associated with poorer health-related quality of life including an increased risk for loneliness, isolation, functional fitness declines, falls, hospitalization and premature mortality. The purpose of this pilot trial is to determine the feasibility and acceptability of a novel intervention to reduce loneliness, improve functional fitness, social connectedness, hearing and health-related quality of life in older adults with HL. METHODS: This 10-week, single-blind, pilot randomized control trial (RCT) will include a convenience sample of ambulatory adults aged 65 years or older with self-reported HL. Following baseline assessments, participants will be randomized to either intervention (exercise, health education, socialization and group auditory rehabilitation (GAR)) or control (GAR only) groups. The intervention group will attend a local YMCA twice a week and the control group once a week. Intervention sessions will include 45 min of strengthening, balance and resistance exercises, 30 min of group walking at a self-selected pace and 60 min of interactive health education or GAR. The control group will attend 60-min GAR sessions. GAR sessions will include education about hearing, hearing technologies, enhancing communication skills, and psychosocial support. Pre-post trial data collection and measures will include: functional fitness (gait speed, 30-s Sit to Stand Test), hearing and health-related quality of life, loneliness, depression, social participation and social support. At trial end, feasibility (recruitment, randomization, retention, acceptability) and GAR will be evaluated. DISCUSSION: Despite evidence suggesting that HL is associated with declines in functional fitness, there are no studies aimed at addressing functional fitness declines associated with the disability of HL. This pilot trial will provide knowledge about the physical, mental and social impacts on health related to HL as a disability. This will inform the feasibility of a larger RCT and preliminary evidence about the initial effects of a novel, community-based, holistic intervention addressing both the negative psychosocial and functional physical effects of HL among older adults. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02662192 . Registered on 14 January 2016.

Thrombin based gelatin matrix and fibrin sealant mediated clot formation in the presence of clopidogrel.

BACKGROUND: Platelet inhibitors are commonly used to reduce the risk of atherothrombotic events. The aim of this study was to determine the impact of platelet inhibitors, specifically clopidogrel and aspirin, on clot kinetics, strength, and/or structure during the use of thrombin based gelatin matrices and fibrin sealants. METHODS: Blood was collected and heparinized from donors on clopidogrel (and aspirin) and age matched control donors. Blood component analysis, whole blood platelet aggregometry, and activated clotting time (ACT) were used to monitor compliance to therapy and identify any differences between donor groups. Clot kinetics and strength were analyzed using thrombelastography (TEG). Field Emission Scanning Electron Microscopy (FESEM) was used to analyze clot structure. RESULTS: Blood component profiles were similar for both donor groups. Aggregometry indicated that aggregation response to adenosine diphosphate (ADP) for clopidogrel donors was 12% of that for the controls (p = 0.0021), an expected result of clopidogrel induced platelet inhibition. However, blood from both donor groups had an elevated thrombin induced aggregation response. Heparinization of donor blood resulted in similarly elevated ACTs for both donor groups. TEG results indicated similar clot kinetics and strength between clopidogrel and control donor groups for blood alone and when clotting was induced using thrombin based gelatin matrices and fibrin sealants. FESEM images supported TEG findings in that similar morphologies were observed in ex vivo formed clots from both donor groups when thrombin based gelatin matrices and fibrin sealants were used. CONCLUSION: These results suggest that platelet inhibitors do not negatively impact clot kinetics, strength, and structure when clotting is initiated with thrombin based gelatin matrices and fibrin sealants.

Paclitaxel nanosuspensions for targeted chemotherapy - nanosuspension preparation, characterization, and use.

OBJECTIVE: The purpose of this work was to prepare a stable paclitaxel nanosuspension and test it for potential use as a targeted chemotherapeutic. Different particle coatings were employed to assess their impact on cellular uptake in vitro. In vivo work was then performed to demonstrate efficacy in tumor-bearing mouse models. MATERIALS AND METHOD: Paclitaxel nanosuspensions were prepared using a homogenization process and coated with excipients. Surface charge was measured by zeta potential, potency by high-performance liquid chromatography, and solubility using an in-line UV probe. Cellular uptake studies were performed via flow cytometry. In vivo experiments were performed to determine residence time, maximum tolerated dose, and the efficacy of paclitaxel nanosuspensions (Paclitaxel-NS). RESULTS: A stable paclitaxel nanosuspension was prepared and coated with various excipients. Studies in mice showed that the nanosuspension was well-tolerated and at least as effective as the IV Taxol control in prolonging mouse survival in a head and neck cancer model as well as an ovarian cancer model with a lower overall drug dose than the traditional IV administration route. CONCLUSIONS: The paclitaxel nanosuspension is suitable for cellular uptake. The nanosuspension was effective in prolonging life in two separate xenograft orthotopic murine cancer models through two separate routes of administration.

A photovoice study of older adults' conceptualizations of risk.

Risk is a multifaceted and complex concept that mediates quality of life through the balance between risk taking and risk avoidance. Society expects older adults to identify and manage their personal risks yet little is known about the meaning of risk in their daily lives and how they balance the tensions between taking and avoiding risks. Therefore the purpose of this study was to explore how older adults construe risk. A qualitative exploratory study that incorporated photovoice methodology was used. Seventeen older adults, over a weeklong period, took pictures and kept a log of the places, spaces, events, activities, or situations that best represented risk. Subsequently, they participated in a follow-up individual interview. Older adults viewed risk both positively and negatively, judging the saliency of a risk according to criteria that related both to the risk itself and to personal characteristics. Although risk was avoided in specific situations, risk taking was participants' primary approach to risk, which assumed three forms: adaptive, opportunistic, and/or unjustifiable. Contrary to societal views, older adults view risk as constructive and personally relevant, and as something to be taken and need to be supported in risk taking rather than risk avoidance.

Forces between insulin microspheres and polymers surfaces for a dry powder inhaler.

Here we demonstrate the use of a colloidal probe atomic force microscope (AFM) to compare the interactions between a model protein microsphere (insulin) and a set of common device polymers (polytetrafluoroethylene, polyethylene and polypropylene) with and without antistatic additive. For inhalation-based delivery devices the solid protein microspheres will interact with the device surfaces under ambient atmospheric conditions, and as such we studied the particle device interaction at a range of relative humidities. The results clearly discriminate between the five different polymer choices, and the impact of the antistatic additive. Although the mechanistic understanding is incomplete, it is evident that the polypropylene with antistatic additive gives consistent and relatively small interaction forces over the entire humidity range. The other polymer surfaces have humidity ranges where the pull-off forces are substantially greater. At 80% relative humidity, the insulin-polymer adhesion forces were similar for all the polymers probably due to the dominance of static charge mitigation and surface hydration effects. Overall, direct measurement of adhesion forces between pharmaceutical microspheres and container substrates can help direct rational choice of plastics/coatings for medical devices.