Effect of two different participant information sheets on recruitment to a falls trial: An embedded randomised recruitment trial.

BACKGROUND/AIMS: Recruitment to trials of intervention for older people who fall is challenging. Evidence suggests that the word falls has negative connotations for older people, and this may present a barrier to engaging with trials in this area. We therefore tested whether a participant information sheet that minimised reference to falls could improve recruitment rates. METHODS: We conducted a study within a trial, embedded within a randomised controlled trial of vitamin K versus placebo to improve postural sway in patients aged 65 and over with a history of falls. Potential participants were identified from primary care lists in 14 practices and were randomised to receive either a standard participant information sheet or an information sheet minimising use of the word falls, instead focussing on maintenance of health, fitness and balance. The primary outcome for this embedded trial was the proportion of responses expressing interest in participating received in each arm. Secondary outcomes were the proportion of those contacted attending a screening visit, consenting at screening, and the proportion contacted who were randomised into the main trial. RESULTS: In all, 4145 invitations were sent, with an overall response rate of 444 (10.7%). In all, 2148 individuals received the new information sheet (minimising reference to falls); 1997 received the standard information sheet. There was no statistically significant difference in response rate between those individuals sent the new information sheet and those sent the standard information sheet (10.1% vs 11.4%; difference 1.3% (95% confidence interval -0.6% to 3.2%); p = 0.19). Similarly, we found no statistically significant difference between the percentage of those who attended and consented at screening in the two groups (2.1% vs 2.7%; difference 0.6% (95% confidence interval: -0.4% to 1.6%); p = 0.20), and no statistically significant difference between the percentage randomised in the two groups (2.0% vs 2.6%; difference 0.6% (95% confidence interval -0.4% to 1.6%); p = 0.20). CONCLUSIONS: Use of a participant information sheet minimising reference to falls did not lead to a greater response rate in this trial targeting older people with a history of falls.

Association between GDF-15 levels and changes in vascular and physical function in older patients with hypertension.

BACKGROUND: Growth differentiation factor-15 (GDF-15) may be a biomarker of disease, protective response and/or prognosis, in older people with hypertension. AIMS: To correlate baseline GDF-15 levels with physical and vascular health data in this population. METHODS: Baseline blood samples were analysed using a GDF-15 ELISA assay kit. Correlations with baseline and 12-month outcome data, including measures of physical and vascular function, were performed. RESULTS: A total of 147 individuals, mean age 76.8 ± 4.7 years, were included. 77 (52 %) were male. Baseline log10GDF-15 showed significant correlations with age (r = 0.37, p < 0.001), total cholesterol (r = -0.33, p < 0.001) and 6-min walking distance (r = -0.37, p < 0.001). Age remained significantly associated with log10GDF-15 in multivariable analysis (beta = -0.29, p = 0.001). Baseline log10GDF-15 was significantly associated with decline in 6-min walk distance over 12 months (beta = -0.27, p = 0.01) in multivariable models. No significant correlations were seen with changes in vascular function over 12 months. CONCLUSION: Baseline GDF-15 predicts declining physical, but not vascular, function in our population.

Effect of Vitamin K2 on Postural Sway in Older People Who Fall: A Randomized Controlled Trial.

OBJECTIVES: Vitamin K is thought to be involved in both bone health and maintenance of neuromuscular function. We tested the effect of vitamin K2 supplementation on postural sway, falls, healthcare costs, and indices of physical function in older people at risk of falls. DESIGN: Parallel-group double-blind randomized placebo-controlled trial. SETTING: Fourteen primary care practices in Scotland, UK. PARTICIPANTS: A total of 95 community-dwelling participants aged 65 and older with at least two falls, or one injurious fall, in the previous year. INTERVENTION: Once/day placebo, 200 µg or 400 µg of oral vitamin K2 for 1 year. MEASUREMENTS: The primary outcome was anteroposterior sway measured using sway plates at 12 months, adjusted for baseline. Secondary outcomes included the Short Physical Performance Battery, Berg Balance Scale, Timed Up & Go Test, quality of life, health and social care costs, falls, and adverse events. RESULTS: Mean participant age was 75 (standard deviation [SD] = 7) years. Overall, 58 of 95 (61%) were female; 77 of 95 (81%) attended the 12-month visit. No significant effect of either vitamin K2 dose was seen on the primary outcome of anteroposterior sway (200 µg vs placebo: -.19 cm [95% confidence interval [CI] -.68 to .30; P = .44]; 400 µg vs placebo: .17 cm [95% CI -.33 to .66; P = .50]; or 400 µg vs 200 µg: .36 cm [95% CI -.11 to .83; P = .14]). Adjusted falls rates were similar in each group. No significant treatment effects were seen for other measures of sway or secondary outcomes. Costs were higher in both vitamin K2 arms than in the placebo arm. CONCLUSION: Oral vitamin K2 supplementation did not improve postural sway or physical function in older people at risk of falls. J Am Geriatr Soc 67:2102-2107, 2019.

Acceptability and feasibility of magnetic femoral nerve stimulation in older, functionally impaired patients.

OBJECTIVE: Magnetic femoral nerve stimulation to test muscle function has been largely unexplored in older people. We assessed acceptability, feasibility, along with reproducibility and correlation with other physical function measures. RESULTS: Study 1 recruited older people with sarcopenia. Stimulation was performed at baseline and 2 weeks along with six minute walk (6MW), maximum voluntary quadriceps contraction, short physical performance battery and grip strength. Acceptability was measured using visual analog scales. Study 2 used baseline data from a trial of older people. We correlated stimulation results with 6MW, maximal voluntary contraction and muscle mass. Maximum quadriceps twitch tension was measured in both studies, evoked using biphasic magnetic stimulation of the femoral nerve. In study 1 (n = 12), magnetic stimulation was well tolerated with mean discomfort rating of 9% (range 0-40%) on a visual analog scale. Reproducibility was poor (intraclass correlation coefficient 0.06; p = 0.44). Study 2 (n = 64) showed only weak to moderate correlations for maximum quadriceps twitch tension with other measures of physical function (6 minute walk test r = 0.24, p = 0.06; maximal voluntary contraction r = 0.26; p = 0.04). We conclude that magnetic femoral nerve stimulation is acceptable and feasible but poorly reproducible in older, functionally impaired people.

Effect of vitamin D supplementation on orthostatic hypotension: data from the vitamin D in isolated systolic hypertension randomized controlled trial.

OBJECTIVE: Orthostatic hypotension commonly accompanies supine hypertension, and is associated with low 25-hydroxyvitamin D levels. We tested whether high-dose intermittent oral vitamin D therapy could ameliorate orthostatic hypotension in older patients with isolated systolic hypertension. METHODS: We conducted a subgroup analysis of data from a parallel-group, double-blind, randomized, placebo-controlled trial. Patients aged over 70 years with supine office SBP above 140 mmHg and DBP below 90 mmHg received 100 000 units oral vitamin D3 or matching placebo every 3 months for 1 year. Office supine and standing blood pressure were measured at baseline, and 3, 6, 9 and 12 months, along with arterial stiffness and flow-mediated dilatation of the brachial artery. RESULTS: Of 159 patients randomized to the main trial, 75 patients with orthostatic hypotension at baseline were included in this analysis. The mean age was 78 (SD 5) years, baseline blood pressure was 162/76 mmHg and the mean baseline orthostatic fall in blood pressure on standing was 32/5 mmHg. After adjustment for baseline age, 25-hydroxyvitamin D, SBP and orthostatic fall, the fall in SBP was less in the vitamin D group at 3 months [treatment effect 6 mmHg, 95% confidence interval (CI) 0 to 12], but repeated-measures analysis showed no significant treatment effect (3 mmHg for systolic fall, 95% CI -1 to 8; 1 mmHg for diastolic fall, 95% CI -1 to 3). CONCLUSION: Twelve months of intermittent, high-dose oral vitamin D3 did not significantly improve orthostatic hypotension in older patients with isolated systolic hypertension.

Cholecalciferol treatment to reduce blood pressure in older patients with isolated systolic hypertension: the VitDISH randomized controlled trial.

IMPORTANCE: Observational data link low 25-hydroxyvitamin D levels to both prevalent blood pressure and incident hypertension. No clinical trial has yet examined the effect of vitamin D supplementation in isolated systolic hypertension, the most common pattern of hypertension in older people. OBJECTIVE: To test whether high-dose, intermittent cholecalciferol supplementation lowers blood pressure in older patients with isolated systolic hypertension. DESIGN: Parallel group, double-blind, placebo-controlled randomized trial. SETTING: Primary care clinics and hospital clinics. PARTICIPANTS: Patients 70 years and older with isolated systolic hypertension (supine systolic blood pressure >140 mm Hg and supine diastolic blood pressure <90 mm Hg) and baseline 25-hydroxyvitamin D levels less than 30 ng/mL were randomized into the trial from June 1, 2009, through May 31, 2011. INTERVENTIONS: A total of 100,000 U of oral cholecalciferol or matching placebo every 3 months for 1 year. MAIN OUTCOMES AND MEASURES: Difference in office blood pressure, 24-hour blood pressure, arterial stiffness, endothelial function, cholesterol level, insulin resistance, and b-type natriuretic peptide level during 12 months. RESULTS: A total of 159 participants were randomized (mean age, 77 years). Mean baseline office systolic blood pressure was 163/78 mm Hg. Mean baseline 25-hydroxyvitamin D level was 18 ng/mL. 25-Hydroxyvitamin D levels increased in the treatment group compared with the placebo group (+8 ng/mL at 1 year, P < .001). No significant treatment effect was seen for mean (95% CI) office blood pressure (−1 [−6 to 4]/−2 [−4 to 1] mm Hg at 3 months and 1 [−2 to 4]/0 [−2 to 2] mm Hg overall treatment effect). No significant treatment effect was evident for any of the secondary outcomes (24-hour blood pressure, arterial stiffness, endothelial function, cholesterol level, glucose level, and walking distance). There was no excess of adverse events in the treatment group, and the total number of falls was nonsignificantly lower in the group receiving vitamin D (36 vs 46, P = .24). CONCLUSIONS AND RELEVANCE: Vitamin D supplementation did not improve blood pressure or markers of vascular health in older patients with isolated systolic hypertension. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN92186858.

Should oral nutritional supplementation be given to undernourished older people upon hospital discharge? A controlled trial.

OBJECTIVES: To determine whether the oral nutritional supplementation of undernourished older people upon discharge from hospital improves muscle function and reduces disability. DESIGN: Randomized controlled trial. SETTING: Community-based study in two centers in Scotland. PARTICIPANTS: Two hundred fifty-three people. INTERVENTION: Randomization to oral nutritional supplementation (600 kcal/d) or control supplement of 200 kcal/d. MEASUREMENTS: Primary outcome (20-point activity of daily living Barthel Index) and secondary outcomes (handgrip strength, Sit-to-Stand test, and Euroquol) were measured at baseline (after discharge from the hospital and before supplement was commenced) and 8 and 16 weeks and accelerometry-measured physical activity levels at baseline and 16 weeks. Falls were recorded prospectively. RESULTS: Mean age was 82. There was no significant difference in change in Barthel score between supplement and control groups (adjusted mean difference=0.28, 95% confidence interval (CI)=-0.28-0.84). Handgrip strength improved more in the supplemented group (adjusted mean difference=1.52 kg, 95% CI=0.50-2.55; P=.004). The supplemented group exhibited modestly greater vector movement (overall activity) than controls (P=.02). There were no significant between-group differences in Sit-to-Stand test, health-related quality of life, or falls. Adherence was 38.2% in the nutritional supplement group and 50.0% in the control supplement group. Weight did not increase in the nutritional supplement group as a whole, but on-treatment analysis adjusting for adherence showed a mean weight gain of 1.17 kg (95% CI=0.07-2.27; P=.04) more than in controls. CONCLUSION: Oral nutritional supplementation of undernourished older people upon hospital discharge did not reduce disability, despite improving handgrip strength and modestly increasing objectively measured physical activity levels. Lack of an effect of the nutritional supplement used in this study may have been due to low adherence, suggesting that different approaches to nutritional supplementation need to be tested in this population.

Defining the nutritional status and dietary intake of older heart failure patients.

BACKGROUND: Little information exists about diet in the management of heart failure. AIMS: To describe the nutritional and biochemical status, and the dietary intake of older heart failure patients. METHODS: Stable outpatients and patients with recent hospitalisation for decompensated heart failure were recruited. Anthropometric measurements, handgrip strength, biochemical values and echocardiography were recorded. Patients kept 7-day food diaries and completed questionnaires concerning food provision. RESULTS: Forty-five patients with a mean (S.D.) age of 80.8 (6.8) years were studied and classed according to the New York Heart Association (NYHA) (11% Class I, 27% Class II and 62% Class III). Mean (S.D.) body mass index (BMI) was 27.1 (5.4) kg/m(2) with 7% of patients having a BMI<20 kg/m(2) and 56% with a BMI above 25 kg/m(2). 64% of participants failed to achieve the estimated average requirements for energy intake; 82% took more than 2 mg of sodium daily; and 18% had a potassium intake above 3500 mg/day. Only 29% of individuals did not need assistance with food shopping, whilst 58% required assistance with meal preparation. CONCLUSION: Possible targets for dietary intervention in older heart failure patients have been identified but whether such changes would be beneficial to patients is unknown.

A personalized snack-based intervention for hip fracture patients: development, feasibility and acceptability.

INTRODUCTION: Undernutrition is common in older people admitted to hospital with hip fracture. Oral supplementation with sip feeds may be provided but compliance is a major problem. OBJECTIVE: To develop a personalized snack-based intervention for practical implementation in hip fracture patients and to assess feasibility, adherence, acceptability and cost. PARTICIPANTS AND METHODS: Twenty-three older hip fracture patients with a mean age (SD) 84.1 (6.3) were provided with three between-meal snacks daily for 4 weeks following surgery. Dietary counselling, assessment of acceptability and feasibility were undertaken and costs of intervention calculated. RESULTS: Sixteen of the 23 participants recruited completed the study. Mean estimated energy derived from the snacks provided 26% of daily energy requirements. Monitoring adherence proved problematic and stocktakes highlighted discrepancies. Although several participants reported that they did not usually eat between meals, overall the intervention was acceptable to participants. The cost of implementation was 21.29 UK pounds per participant per week. CONCLUSIONS: Although it proved feasible, practical difficulties were encountered with implementation and adherence due to timing. A more appropriate time to deliver such an intervention may be after the acute phase is over and patients are back home. The costs compared favourably with the alternative of providing sip feeds.

Does ingestion of cranberry juice reduce symptomatic urinary tract infections in older people in hospital? A double-blind, placebo-controlled trial.

BACKGROUND: cranberry juice is often given to older people in hospital to prevent urinary tract infection (UTI), although there is little evidence to support its use. OBJECTIVE: to assess whether cranberry juice ingestion is effective in reducing UTIs in older people in hospital. DESIGN: randomised, placebo-controlled, double-blind trial. SETTING: Medicine for the Elderly assessment and rehabilitation hospital wards. SUBJECTS: 376 older patients in hospital. METHODS: participants were randomised to daily ingestion of 300 ml of cranberry juice or matching placebo beverage. The primary outcome was time to onset of first UTI. Secondary outcomes were adherence to beverage drinking, courses of antibiotics prescribed, and organisms responsible for UTIs. RESULTS: a total of 21/376 (5.6%) participants developed a symptomatic UTI: 14/189 in the placebo group and 7/187 in the cranberry juice group. These between-group differences were not significant, relative risk (RR) 0.51 [95% CI 0.21-1.22, P = 0.122). Although there were significantly fewer infections with Escherichia coli in the cranberry group (13 versus 4) RR 0.31 [95% CI 0.10-0.94, P = 0.027], this should be interpreted with caution as it was a secondary outcome. CONCLUSION: despite having the largest sample size of any clinical trial yet to have examined the effect of cranberry juice ingestion, the actual infection rate observed was lower than anticipated, making the study underpowered. This study has confirmed the acceptability of cranberry juice to older people. Larger trials are now required to determine whether it is effective in reducing UTIs in older hospital patients.