Dataset Information

Multimodal Intervention to Improve Functional Status in Hypertensive Older Adults: A Pilot Randomized Controlled Trial.

ABSTRACT: This pilot randomized controlled trial (RCT) was designed to provide the preliminary data necessary to conduct a full-scale trial to compare the efficacy of differing first-line antihypertensive medications in improving functional status in older adults, when combined with exercise. The primary objectives were to assess study feasibility, safety, and protocol integrity. Dependent outcomes included gait speed, exercise capacity, body composition, and systemic cardiometabolic biomarkers. Thirty-one physically inactive older adults (70.6 ± 6.1 years) with hypertension and functional limitations were randomly assigned to 1) Perindopril (8 mg/day n = 10), 2) Losartan (100 mg/day; n = 13), or 3) Hydrochlorothiazide (HCTZ: 25 mg/day; n = 8). Participants were also assigned to a 24-week multimodal exercise intervention, separated into an aerobic and concurrent (aerobic + resistance) phase to evaluate potential mode effects. Retention was 84% (26/31), and compliance was >90% and >79% with medication and exercise, respectively. A total of 29 adverse events (Perindopril = 5; Losartan = 12; HCTZ = 11) and one unrelated serious adverse event were observed throughout the trial. Overall, this pilot RCT provided critical data and identified several challenges to ultimately designing and implementing a fully powered trial.

SUBMITTER: Baptista LC

PROVIDER: S-EPMC6406861 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Multimodal Intervention to Improve Functional Status in Hypertensive Older Adults: A Pilot Randomized Controlled Trial.

Baptista Liliana C LC Jaeger Byron C BC Anton Stephen D SD Bavry Anthony A AA Handberg Eileen M EM Gardner Anna K AK Harper Sara A SA Roberts Lisa M LM Sandesara Bhanuprasad B Carter Christy S CS Buford Thomas W TW

Journal of clinical medicine 20190206 2

This pilot randomized controlled trial (RCT) was designed to provide the preliminary data necessary to conduct a full-scale trial to compare the efficacy of differing first-line antihypertensive medications in improving functional status in older adults, when combined with exercise. The primary objectives were to assess study feasibility, safety, and protocol integrity. Dependent outcomes included gait speed, exercise capacity, body composition, and systemic cardiometabolic biomarkers. Thirty-on ...[more]

PMID: 30736317

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Project description:BackgroundHospitalization is a major risk factor for functional decline, disability, loss of independence, and mortality in older adults. Evidence-based interventions to improve functional recovery from hospitalization are difficult to evaluate and implement in geriatric patients. The goal of this pilot study was to test the feasibility of recruiting geriatric inpatients and implementing pragmatic interventions to improve physical function following hospitalization.MethodsEnrolled subjects were randomized to one of five 30-day posthospitalization interventions: isocaloric placebo (P), whey protein supplement (W), in-home rehabilitation+placebo (R+P), rehabilitation+whey protein (R+W), or testosterone (T). Data were collected from a single-site university hospital to determine: (i) institution-based feasibility (nonmodifiable factors including number of patients screened, eligible, contacted) and (ii) patient-based feasibility (modifiable factors including number of patients refusing, enrolled, randomized, intervention adherence, and withdrawal).ResultsFrom January 2014 to July 2016, 4,533 patients were chart screened; 594 (13.1%) were eligible to participate; 384 eligible subjects were contacted; 113 were enrolled; and 100 were randomized. Supplement adherence was 75% and was not different by age, education, level of independence, depression, supplement type, or dual intervention, but was significantly higher in subjects who completed the intervention (p < .01). Rehabilitation session adherence was 77% and did not vary significantly by age, education, level of independence, depression, or supplement type, but was significantly higher for sessions directly supervised (p < .01). Adherence was 100% in the testosterone arm with 94.7% of injections given within 24 hours of discharge.ConclusionsFindings from this clinical trial indicate that posthospitalization interventions in geriatric patients are feasible at both the institution and patient level.

Project description:BACKGROUND:Persons living with dementia represent a significant and growing segment of the older adult (aged 65 years and older) population. They are often challenged expressively and may experience difficulties with sharing their feelings or moods. Availability of, and easy access to, tablets facilitates the use of information and communication technologies (ICTs) as a delivery mechanism for nonpharmacological interventions, especially for persons living with dementia. Evidence of the impact of ICTs in different community settings on mood with older adults and the impact of engagement on their caregivers is needed to promote broader adoption and sustainment of these technologies in the United States. OBJECTIVE:This study aimed to determine the extent of the effects of tablets on positive mood change and examine the effects of study variables on care recipients' mood changes and caregivers' daily interactions. METHODS:The tablet intervention was developed and evaluated in five programs. The primary outcome was caregivers' assessment of care recipients' mood (n=1089) before and after a tablet engagement session using an eight-point mood visual analog scale. Session influence on caregivers' daily activities was captured for a subsample of participants (n=542). Frequency distributions were computed for each study variables. Chi-square tests of association were calculated to determine the association of the variables on mood changes for all care recipients, as well as those being treated in skilled nursing facilities and in-home, and then for those that affected caregivers' daily activities. RESULTS:The study sample comprised 1089 care recipient and caregiver engagement sessions. Cumulatively, 50.78% (553/1089) of care recipients showed a transition from negative to positive moods, whereas another 41.78% (455/1089) maintained an already-positive mood after the caregiver engagement session. Chi-square analyses demonstrated that positive mood changes resulted from using music (χ210=72.9; P<.001), using YouTube as the sole app (χ212=64.5; P<.001), using multiple engagement strategies (χ22=42.8; P<.001), and when cared for in a skilled nursing facility (χ24=236.8; P<.001) across the entire care recipient sample. In addition, although many features of the engagement session positively influenced the caregivers' day, the largest effect was observed when care recipients' mood was considered to have improved following the session (χ24=234.7; P<.001). CONCLUSIONS:The study is one of the first in the United States to explore the impact of ICTs, in particular managed tablets and Web-based video services that can be used on a tablet through an app, on improving mood in persons living with dementia, and enhancing caregivers' perceptions about their care recipient interactions. Importantly, these pilot data substantiate ICTs as part of a personalized engagement approach, as beneficial alternatives to pharmaceutical interventions for mood enhancement. However, a more comprehensive study that explores the ICT's impact on additional clinical outcomes is needed to confirm these preliminary findings.

Project description:IntroductionChanging health behaviours is an important and difficult task. Despite growing interest in behavioural theories and models, there is a paucity of research examining their validity in explaining oral health behaviours, and there is a need for interventional studies to assess their effectiveness in improving oral health. This study aims to test the explanatory power of the dominant psychological theories, develop theory-derived intervention and evaluate its effectiveness in improving oral health of older adults.Methods and analysis440 community dwelling older adults will be recruited. To be eligible for this trial, one needs to be 55-79 years old, having at least 8 natural teeth, and with no life-threatening disease, impaired cognitive function, or radiotherapy in the head and neck region. At the initial visit, each participant will be required to complete a detailed questionnaire which collects information on sociodemographic background, oral health behaviours and domains of three psychological theories and models: (1) health belief model, (2) theory of planned behaviour and (3) social cognitive theory. The theory or model that best explains the health behaviours will be selected for designing the oral health intervention. The effectiveness of the theory-derived intervention will be evaluated in a randomised controlled trial. Participants will be randomly assigned to two groups, receiving theory-derived intervention and conventional health education, respectively. At baseline and at 12 and 24 months post intervention, each participant will complete a short questionnaire and undergo an oral examination (dental check-up). The effectiveness of the interventions will be evaluated using behavioural outcomes (diet, toothbrushing, interdental cleaning) and clinical outcomes (oral hygiene, dental caries and periodontal conditions).Ethics and disseminationThis study has been approved by the Institutional Review Board of National University of Singapore (Ref: NUS-IRB-2020-417). Findings will be presented in international conferences and peer-reviewed journals.Trial registration numberNCT04946292.

Project description:IntroductionPhysical activity (PA) and replete nutritional status are key to maintaining independence and improving frailty status among frail older adults. In response to the COVID-19 pandemic, healthcare has increasingly turned to virtual modes of delivery and there is interest in the use of trained volunteers to deliver PA and nutrition interventions. We aim to evaluate the feasibility and acceptability of training hospital volunteers to deliver an online intervention, comprising exercise, behaviour change and nutrition support, to older people with frailty after discharge from hospital.MethodsWe will use a quasi-experimental mixed methods approach. Hospital volunteers (n=6) will be trained to deliver an online, 3-month, multimodal intervention to frail (Clinical Frailty Scale ≥5) adults ≥65 years (n=30) after discharge from hospital. Feasibility will be assessed by determining the number of volunteers recruited, trained and retained at the end of the study; the proportion of intervention sessions delivered; participant recruitment, retention and adherence to the intervention. To determine the acceptability of the intervention, interviews will be conducted among a purposive sample of older adults, and volunteers. Secondary outcomes will include physical function, appetite, well-being, quality of life, anxiety and depression, self-efficacy for managing chronic disease and PA. Outcomes will be measured at baseline, 3 months and 6 months.AnalysisDescriptive statistics will be used to describe feasibility and adherence to the intervention. Secondary outcomes at baseline will be compared at 3 and 6 months. Interviews will be transcribed verbatim and analysed using thematic analysis.Ethics and disseminationHealth Research Authority ethical approval was obtained on 30 May 2022 (reference: 22/WA/0155). Results will be disseminated through peer-reviewed journal articles, volunteer organisations, National Health Service communication systems and social media platforms. A toolkit will be developed to facilitate roll out of volunteer training.Trial registration numberNCT05384730.

Project description:ObjectiveAgeing is associated with a progressive decline in physical function and cognitive performance which could result in a shift from an independent to a more dependent lifestyle. The aim of this research study was to assess the fitness, functional performance and cognitive ability in independently living older South Africans and to determine which fitness parameters and functional performance tests best explain the variance in cognitive function.DesignDescriptive observational study.ParticipantsOlder adults with a mean age 71±4.7 years (n = 70; 28 men and 42 women) were recruited. Sixty percent of the sample completed at least secondary schooling and more than two-thirds were taking medication for a chronic medical condition.MeasurementsSelf-reported physical activity was assessed using the Yale Physical Activity Survey. Fitness tests included the 6-minute walk test and Bicep Curls. The functional performance tests were; Static and Dynamic balance, Timed Up and Go, Sit to Stand, Grip strength and Functional Reach. The Stroop Task and 6-Item cognitive impairment test were used to measure cognitive performance. Bivariate and multivariate analyses were conducted between performance on the novel cognitive Stroop Task and functional and cognitive tests.ResultsWe found significant relationships between the number of correct responses on the Stroop Task and scores on the 6-Item Cognitive Impairment test (-0.520, p < 0.01) and grip strength (r = 0.42, p< 0.01). The number of incorrect responses was inversely associated with functional reach (r = -0.445, p< 0.01). The final regression model included: age, dynamic balance, right arm grip strength and the score on the 6-item cognitive impairment test, and explained 44% of the variance in performance of the Stroop Task.ConclusionsThe results of this study showed that measures of physical function were associated with cognitive performance even in highly functioning older South African adults. Further research is needed to determine the extent to which exercise training can improve functional capacity and the effect on cognitive performance.

Dataset Information

Multimodal Intervention to Improve Functional Status in Hypertensive Older Adults: A Pilot Randomized Controlled Trial.

Publications

Multimodal Intervention to Improve Functional Status in Hypertensive Older Adults: A Pilot Randomized Controlled Trial.

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