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A pilot randomized controlled trial to improve geriatric frailty.

ABSTRACT: Few randomized controlled trials (RCTs) report interventions targeting improvement of frailty status as an outcome.This RCT enrolled 117 older adults (65-79?years of age) in Toufen, Taiwan who scored 3-6 on The Chinese Canadian Study of Health and Aging Clinical Frailty Scale Telephone Version and then score ?1 on the Cardiovascular Health Study Phenotypic Classification of Frailty (CHS_PCF). With a two by two factorial design, subjects were randomly assigned to interventions (Exercise and nutrition, EN, n?=?55 or problem solving therapy, PST, n?=?57) or controls (non-EN, n?=?62 or non-PST, n?=?60). Educational booklets were provided to all. EN group subjects received nutrition consultation and a thrice-weekly exercise-training program while PST group subjects received 6 sessions in 3?month. Subjects were followed at 3, 6, and 12?months. Primary outcome was improvement of the CHS_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments. One hundred and one completed final assessments. Intention-to-treat analysis with the generalized estimating equation model was applied with adjustment for time and treatment-by-time interactions.Mean age was 71.4?±?3.7?years, with 59% females. Baseline characteristic were generally comparable between groups. EN group subjects had a higher improvement rate on the primary outcome than non-EN group subjects (45% vs 27%, adjusted p?=?0.008) at 3?months, but not 6 or 12?months. They also had more increase of serum 25(OH) vitamin D level (4.9?±?7.7 vs 1.2?±?5.4, p?=?0.006) and lower percentage of osteopenia (74% vs 89% p?=?0.042) at 12?months. PST group subjects had better improvement (2.7?±?6.1 vs 0.2?±?6.7, p?=?0.035, 6-month) and less deterioration (-3.5?±?9.7 vs -7.1?±?8.7, p?=?0.036, 12-month) of dominant leg extension power than non-PST subjects. Some secondary outcomes were also improved in control groups (non-EN or non-PST). No adverse effects were reported.The three-month EN intervention resulted in short-term (3-month) frailty status improvement and long-term effect on bone mineral density and serum vitamin D (12-month) among Taiwanese community-dwelling elders. The effect of PST was less pronounced.ClinicalTrials.gov: EC0970301

SUBMITTER: Chan DC

PROVIDER: S-EPMC3490887 | biostudies-other | 2012

REPOSITORIES: biostudies-other

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A pilot randomized controlled trial to improve geriatric frailty.

Chan Ding-Cheng Derrick DC Tsou Hsiao-Hui HH Yang Rong-Sen RS Tsauo Jau-Yih JY Chen Ching-Yu CY Hsiung Chao Agnes CA Kuo Ken N KN

BMC geriatrics 20120925

<h4>Background</h4>Few randomized controlled trials (RCTs) report interventions targeting improvement of frailty status as an outcome.<h4>Methods</h4>This RCT enrolled 117 older adults (65-79 years of age) in Toufen, Taiwan who scored 3-6 on The Chinese Canadian Study of Health and Aging Clinical Frailty Scale Telephone Version and then score ≥1 on the Cardiovascular Health Study Phenotypic Classification of Frailty (CHS_PCF). With a two by two factorial design, subjects were randomly assigned t ...[more]

PMID: 23009149

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Project description:BACKGROUND:Exercise, nutrition, and psychological interventions may all have positive impacts on frailty and sarcopenia. However, it is not known whether an integrated care programme with all three components can be beneficial and the intensity of such programme is also not certain. In this study, we aim to determine the effectiveness of two levels of integrated care on frailty and sarcopenia. METHODS:A randomized control trial was conducted at two community hospitals in Taiwan. Older adults (65-79?years of age, N?=?289) who scored ?1 on the Cardiovascular Health Study Phenotypic Classification of Frailty (CHS_PCF) were enrolled in the trial. Low-level care (LLC) participants received a 2?h education course on frailty, sarcopenia, coping strategy, nutrition, and demonstration of study exercise programme. Educational multimedia material was distributed as reference for home practice with bi-monthly telephone follow-ups on adherences. High-level care (HLC) participants, in addition to LLC instructions, received six sessions of on-site problem solving therapy and 48 exercise sessions within 6?months. Brief nutrition consultation was also provided during the exercise sessions. Primary outcome was improvement of the CHS_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline. Secondary outcomes included changes of individual frailty, and sarcopenia indicators. Assessments were done at 3, 6, and 12?months by trained research assistants blinded to randomization status. Intention-to-treat analysis was applied. RESULTS:Mean age was 71.6?±?4.3?years, with 53% females. For the entire cohort, improvement of primary outcome was 35% at 3?months, increased to 40% at 6?months, and remained stable at 39% at 12?months. Improvement rates were similar in both groups. Compared with the LLC group, HLC participants had greater improvements in the following indices: energy expenditure of walking, 5?m walking time, dominant hand grip strength, timed-up-and-go-test, and one-leg-stand time - mainly at 6 and 12?month assessments. CONCLUSIONS:The 6?month integrated care improved frailty and sarcopenia status among community-dwelling elders, with high-intensity training yielding greater improvements. Low-level care could be promoted as a basic intervention, while HLC could be reserved for those at high risk and with high motivation.

Project description:BackgroundImproving mobility in elderly persons is a primary goal in geriatric rehabilitation. Self-regulated exercises with instruction leaflets are used to increase training volume but adherence is often low. Exergames may improve adherence. This study therefore compared exergames with self-regulated exercise using instruction leaflets. The primary outcome was adherence. Secondary outcomes were enjoyment, motivation and balance during walking.MethodsDesign: single center parallel group non-blinded randomized controlled trial with central stratified randomization.Settingcenter for geriatric inpatient rehabilitation. Included were patients over 65 with mobility restrictions who were able to perform self-regulated exercise. Patients were assigned to self-regulated exercise using a) exergames on Windows Kinect® (exergame group EG) or b) instruction leaflets (conventional group CG). During two 30 min sessions physical therapists instructed self-regulated exercise to be conducted twice daily during thirty minutes during ten working days. Patients reported adherence (primary outcome), enjoyment and motivation daily. Balance during walking was measured blind before and after the treatment phase with an accelerometer. Analysis was by intention to treat. Repeated measures mixed models and Cohen's d effect sizes (ES, moderate if >0.5, large if > 0.8) with 95% CIs were used to evaluate between-group effects over time. Alpha was set at 0.05.ResultsFrom June 2014 to December 2015 217 patients were evaluated and 54 included, 26 in the EG and 28 in the CG. Adverse effects were observed in two patients in the EG who stopped because of pain during exercising. Adherence was comparable at day one (38 min. in the EG and 42 min. in the CG) and significantly higher in the CG at day 10 (54 min. in the CG while decreasing to 28 min. in the EG, p = 0.007, ES 0.94, 0.39-0.151). Benefits favoring the CG were also observed for enjoyment (p = 0.001, ES 0.88, 0.32 - 1.44) and motivation (p = 0.046, ES 0.59, 0.05-1.14)). There was no between-group effect in balance during walking.ConclusionsSelf-regulated exercise using instruction leaflets is superior to exergames regarding adherence, enjoyment and motivation in a geriatric inpatient rehabilitation setting. Effects were moderate to large. There was no between group difference in balance during walking.Trial registrationClinicalTrials.gov, NCT02077049 , 6 February 2014.

Project description:BackgroundComprehensive geriatric assessment provided in hospital wards in frail patients admitted to hospital has been shown to reduce mortality and increase the likelihood of living at home later. Systematic geriatric assessment provided in emergency departments (ED) may be effective for reducing days in hospital and unnecessary hospital admissions, but this has not yet been proven in randomised trials.MethodsWe conducted a single-centre, randomised controlled trial with a parallel-group, superiority design in an academic hospital ED. ED patients aged ≥ 75 years who were frail, or at risk of frailty, as defined by the Clinical Frailty Scale, were included in the trial. Patients were recruited during the period between December 11, 2018 and June 7, 2019, and followed up for 365 days. For the intervention group, systematic geriatric assessment was added to their standard care in the ED, whereas the control group received standard care only. The primary outcome was cumulative hospital stay during 365-day follow-up. The secondary outcomes included: admission rate from the index visit, total hospital admissions, ED-readmissions, proportion of patients living at home at 365 days, 365-day mortality, and fall-related ED-visits.ResultsA total of 432 patients, 63 % female, with median age of 85 years, formed the analytic sample of 213 patients in the intervention group and 219 patients in the control group. Cumulative hospital stay during one-year follow-up as rate per 100 person-years for the intervention and control groups were: 3470 and 3149 days, respectively, with rate ratio of 1.10 (95 % confidence interval, 0.55-2.19, P = .78). Admission rates to hospital wards from the index ED visit for the intervention and control groups were: 62 and 70 %, respectively (P = .10). No significant differences were observed between the groups for any outcomes.ConclusionSystematic geriatric assessment for older adults with frailty in the ED did not reduce hospital stay during one-year follow-up. No statistically significant difference was observed for any secondary outcomes. More coordinated, continuous interventions should be tested for potential benefits in long-term outcomes.Trial registrationThe trial was registered in the ClinicalTrials.gov (registration number and date NCT03751319 23/11/2018).

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A pilot randomized controlled trial to improve geriatric frailty.

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A pilot randomized controlled trial to improve geriatric frailty.

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