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A study protocol of a randomised controlled trial to measure the effects of an augmented prescribed exercise programme (APEP) for frail older medical patients in the acute setting.

ABSTRACT: Older adults experience functional decline in hospital leading to increased healthcare burden and morbidity. The benefits of augmented exercise in hospital remain uncertain. The aim of this trial is to measure the short and longer-term effects of augmented exercise for older medical in-patients on their physical performance, quality of life and health care utilisation.Two hundred and twenty older medical patients will be blindly randomly allocated to the intervention or sham groups. Both groups will receive usual care (including routine physiotherapy care) augmented by two daily exercise sessions. The sham group will receive stretching and relaxation exercises while the intervention group will receive tailored strengthening and balance exercises. Differences between groups will be measured at baseline, discharge, and three months. The primary outcome measure will be length of stay. The secondary outcome measures will be healthcare utilisation, activity (accelerometry), physical performance (Short Physical Performance Battery), falls history in hospital and quality of life (EQ-5D-5 L).This simple intervention has the potential to transform the outcomes of the older patient in the acute setting.ClinicalTrials.gov Identifier: NCT02463864 , registered 26.05.2015.

SUBMITTER: McCullagh R

PROVIDER: S-EPMC4826551 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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A study protocol of a randomised controlled trial to measure the effects of an augmented prescribed exercise programme (APEP) for frail older medical patients in the acute setting.

McCullagh Ruth R O'Connell Eimear E O'Meara Sarah S Perry Ivan I Fitzgerald Anthony A O'Connor Kieran K Horgan N Frances NF Timmons Suzanne S

BMC geriatrics 20160408

<h4>Background</h4>Older adults experience functional decline in hospital leading to increased healthcare burden and morbidity. The benefits of augmented exercise in hospital remain uncertain. The aim of this trial is to measure the short and longer-term effects of augmented exercise for older medical in-patients on their physical performance, quality of life and health care utilisation.<h4>Design & methods</h4>Two hundred and twenty older medical patients will be blindly randomly allocated to t ...[more]

PMID: 27059306

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Project description:BackgroundThere is inconclusive evidence for the effectiveness of additional exercise in older hospital patients. The aims of this study were (1) to assess the feasibility of an augmented prescribed exercise program (APEP) in older acute medical patients and (2) to measure the potential effects of APEP on mobility capacity in order to assess the feasibility of a large full-scale study.MethodsWe conducted a single-center, prospective, parallel-group, single-blinded, randomized (1:1) controlled pilot and feasibility trial. Participants were recruited from acute geriatric wards of a general hospital. Key inclusion criteria were: age ≥ 65 years and walking ability. Key exclusion criteria were severe cognitive impairment and medical restriction for physical exercise interventions. Both groups received usual care, including physiotherapy. Intervention group participants were scheduled for additional exercise sessions (20-30 min, 4-5x/week). Feasibility of the trial design was assessed along pre-defined criteria for process, resources and management. Feasibility of the APEP intervention was analyzed by means of adherence, compliance and safety. Outcomes were measured at baseline and prior to hospital discharge. The primary outcome was mobility capacity (de Morton Mobility Index; DEMMI). Secondary outcomes were walking ability, physical endurance, fear of falling, frailty and length of stay.ResultsThirty-five participants were recruited (recruitment rate 20.3%). We lost 7 participants to follow-up (retention rate: 80%). Intervention group participants (n = 17) each participated in 5.3 ± 2.2 additional exercise sessions (mean duration: 23.2 ± 4.0 min; mean adherence rate 78% ± 26%). No severe adverse events occurred during study assessments or APEP sessions. There were no statistically significant differences in mean change scores in any outcome measure. A sample of 124 participants would be required to detect a difference of 4 DEMMI points (ES = 0.45) with a power of 80%.ConclusionsThis small feasibility RCT indicates that an APEP intervention may be safe and feasible in older acute medical patients. APEP may possibly induce small to moderate effects on mobility, but the clinical relevance of these effects may be limited. These results inform the planning of a larger-scale phase III study.Trial registrationGerman Clinical Trials Register ( DRKS00011262 ). Registered 27 October 2016.

Project description:IntroductionFrailty is highly prevalent in adults with chronic kidney disease (CKD) and is associated with adverse health outcomes including falls, poorer health-related quality of life (HRQOL), hospitalisation and mortality. Low physical activity and muscle wasting are important contributors to physical frailty in adults with CKD. Exercise training may improve physical function and frailty status leading to associated improvements in health outcomes, including HRQOL. The EX-FRAIL CKD trial aims to inform the design of a definitive randomised controlled trial (RCT) that investigates the effectiveness of a progressive, multicomponent home-based exercise programme in prefrail and frail older adults with CKD.Methods and analysisThe EX-FRAIL CKD trial is a two-arm parallel group pilot RCT. Participants categorised as prefrail or frail, following Frailty Phenotype (FP) assessment, will be randomised to receive exercise or usual care. Participants randomised to the intervention arm will receive a tailored 12-week exercise programme, which includes weekly telephone calls to advise on exercise progression. Primary feasibility outcome measures include rate of recruitment, intervention adherence, outcome measure completion and participant attrition. Semistructured interviews with a purposively selected group of participants will inform the feasibility of the randomisation procedures, outcome measures and intervention. Secondary outcome measures include physical function (walking speed and Short Physical Performance Battery), frailty status (FP), fall concern (Falls Efficacy Scale-International tool), activities of daily living (Barthel Index), symptom burden (Palliative care Outcome Scale-Symptoms RENAL) and HRQOL (Short Form-12v2).Ethics and disseminationEthical approval was granted by a National Health Service (NHS) Regional Ethics Committee and the NHS Health Research Authority. The study team aims to publish findings in a peer-reviewed journal and presents the results at relevant national and international conferences. A summary of findings will be provided to participants, a local kidney patient charity and the funding body.Trial registration numberISRCTN87708989.

Project description:ObjectivesDeprescribing has been proposed as a way to reduce polypharmacy in frail older people. We aimed to reduce the number of medicines consumed by people living in residential aged care facilities (RACF). Secondary objectives were to explore the effect of deprescribing on survival, falls, fractures, hospital admissions, cognitive, physical, and bowel function, quality of life, and sleep.MethodsNinety-five people aged over 65 years living in four RACF in rural mid-west Western Australia were randomised in an open study. The intervention group (n = 47) received a deprescribing intervention, the planned cessation of non-beneficial medicines. The control group (n = 48) received usual care. Participants were monitored for twelve months from randomisation. Primary outcome was change in the mean number of unique regular medicines. All outcomes were assessed at baseline, six, and twelve months.ResultsStudy participants had a mean age of 84.3 ± 6.9 years and 52% were female. Intervention group participants consumed 9.6 ± 5.0 and control group participants consumed 9.5 ± 3.6 unique regular medicines at baseline. Of the 348 medicines targeted for deprescribing (7.4 ± 3.8 per person, 78% of regular medicines), 207 medicines (4.4 ± 3.4 per person, 59% of targeted medicines) were successfully discontinued. The mean change in number of regular medicines at 12 months was -1.9 ± 4.1 in intervention group participants and +0.1 ± 3.5 in control group participants (estimated difference 2.0 ± 0.9, 95%CI 0.08, 3.8, p = 0.04). Twelve intervention participants and 19 control participants died within 12 months of randomisation (26% versus 40% mortality, p = 0.16, HR 0.60, 95%CI 0.30 to 1.22) There were no significant differences between groups in other secondary outcomes. The main limitations of this study were the open design and small participant numbers.ConclusionsDeprescribing reduced the number of regular medicines consumed by frail older people living in residential care with no significant adverse effects on survival or other clinical outcomes.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12611000370909.

Project description:BackgroundPoor outcomes and high resource-use are observed for frail older people discharged from acute medical units. A specialist geriatric medical intervention, to facilitate Comprehensive Geriatric Assessment, was developed to reduce the incidence of adverse outcomes and associated high resource-use in this group in the post-discharge period.ObjectiveTo examine the costs and cost-effectiveness of a specialist geriatric medical intervention for frail older people in the 90 days following discharge from an acute medical unit, compared with standard care.MethodsEconomic evaluation was conducted alongside a two-centre randomised controlled trial (AMIGOS). 433 patients (aged 70 or over) at risk of future health problems, discharged from acute medical units within 72 hours of attending hospital, were recruited in two general hospitals in Nottingham and Leicester, UK. Participants were randomised to the intervention, comprising geriatrician assessment in acute units and further specialist management, or to control where patients received no additional intervention over and above standard care. Primary outcome was incremental cost per quality adjusted life year (QALY) gained.ResultsWe undertook cost-effectiveness analysis for 417 patients (intervention: 205). The difference in mean adjusted QALYs gained between groups at 3 months was -0.001 (95% confidence interval [CI]: -0.009, 0.007). Total adjusted secondary and social care costs, including direct costs of the intervention, at 3 months were £4412 (€5624, $6878) and £4110 (€5239, $6408) for the intervention and standard care groups, the incremental cost was £302 (95% CI: 193, 410) [€385, $471]. The intervention was dominated by standard care with probability of 62%, and with 0% probability of cost-effectiveness (at £20,000/QALY threshold).ConclusionsThe specialist geriatric medical intervention for frail older people discharged from acute medical unit was not cost-effective. Further research on designing effective and cost-effective specialist service for frail older people discharged from acute medical units is needed.Trial registrationISRCTN registry ISRCTN21800480 http://www.isrctn.com/ISRCTN21800480.

Project description:IntroductionPhysical activity (PA) is important for healthy ageing. Better insight into objectively measured PA levels in older adults is needed, since most previous studies employed self-report measures for PA assessment, which are associated with overestimation of PA.AimThis study aimed to provide insight in objectively measured indoor and outdoor PA of older adults, and in PA differences by frailty levels.MethodsData were collected among non-frail (N = 74) and frail (N = 10) subjects, aged 65 to 89 years. PA, measured for seven days with accelerometers and GPS-devices, was categorized into three levels of intensity (sedentary, light, and moderate-to-vigorous PA).ResultsOlder adults spent most time in sedentary and light PA. Subjects spent 84.7%, 15.1% and 0.2% per day in sedentary, light and moderate-to-vigorous PA respectively. On average, older adults spent 9.8 (SD 23.7) minutes per week in moderate-to-vigorous activity, and 747.0 (SD 389.6) minutes per week in light activity. None of the subjects met the WHO recommendations of 150 weekly minutes of moderate-to-vigorous PA. Age-, sex- and health status-adjusted results revealed no differences in PA between non-frail and frail older adults. Subjects spent significantly more sedentary time at home, than not at home. Non-frail subjects spent significantly more time not at home during moderate-to-vigorous activities, than at home.ConclusionsObjective assessment of PA in older adults revealed that most PA was of light intensity, and time spent in moderate-to-vigorous PA was very low. None of the older adults met the World Health Organization recommendations for PA. These levels of MVPA are much lower than generally reported based on self-reported PA. Future studies should employ objective methods, and age specific thresholds for healthy PA levels in older adults are needed. These results emphasize the need for effective strategies for healthy PA levels for the growing proportion of older adults.

Project description:Quarantine during the COVID-19 pandemic resulted in longer-term sedentary behaviours and mental health problems. Our study aimed to evaluate the impact of the Otago exercise programme (OEP) on physical function and mental health among elderly with cognitive frailty during COVID-19. Lockdowns and restrictions during the COVID-19 pandemic result in longer-term sedentary behaviours related disease and mental problem. Older people with cognitive frailty are more vulnerable to be influenced. Timely intervention may achieve better outcomes, OEP exercise was designed as a balance and muscle-strengthening programme for elderly people. A parallel-group, assessor-blinded randomised controlled trial was performed according to CONSORT guidelines. This study was conducted from July 2020 to October 2020 among 62 elderly people with cognitive frailty from a nursing home. Participants were randomly divided into an OEP group (n = 31) or a control group (n = 31). Both groups received sleep- and diet-related health education. The OEP group also received a 12-week group exercise programme. The Five Times Sit to Stand Test (FTSST), Berg Balance Scale (BBS), and Timed Up and Go Test (TUGT) were used to assess physical function. The Geriatric Depression Scale-15 (GDS-15) and the 12-Item Short Form Health Survey Mental Component Summary (SF-12 MCS) were used to assess mental health. Outcomes were measured at 6 and 12 weeks. Physical function and mental health were similar in the two groups at baseline. At 12 weeks, the OEP group (difference in change from baseline: FTSST, -2.78; TUGT, -3.73; BBS, 2.17; GDS-15, -0.72; SF-12 MCS, 2.58; all p < .001) exhibited significantly greater improvements than the control group (difference in change from baseline: FTSST, 1.55; TUGT, 1.66; BBS, -0.10; GDS-15, 1.07; SF-12 MCS, -5.95; all p < .001). Our findings showed the OEP group had better physical function and mental health outcomes than the control group. OEP can be used to improve the physical and mental function among elderly people with cognitive frailty during the COVID-19 pandemic. Otago exercise program intervention programmes should be implemented to improve physical function for cognitive frailty elderly to reduce the harm of longer-term sedentary behaviours, and to ruduce depression symptom and improve mental health, particularly during COVID-19 pandemic period.

Dataset Information

A study protocol of a randomised controlled trial to measure the effects of an augmented prescribed exercise programme (APEP) for frail older medical patients in the acute setting.

Publications

A study protocol of a randomised controlled trial to measure the effects of an augmented prescribed exercise programme (APEP) for frail older medical patients in the acute setting.

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