scholarly journals Semi-Recumbent Vibration Exercise in Older Adults: A Pilot Study of Methodology, Feasibility, and Safety

2019 ◽  
Vol 5 ◽  
pp. 233372141988155
Author(s):  
Murad H. Taani ◽  
Ellen Siglinsky ◽  
Jessie Libber ◽  
Diane Krueger ◽  
Neil Binkley ◽  
...  

Objectives: Older adults with impaired physical function are at risk for further functional decline in part due to limited ability to engage in regular exercise. Effective approaches to exercise in this vulnerable population are needed to improve functional capacity and optimize independence. Methods: Thirty-two residential care apartment complex (RCAC) residents, age ≥70, with low short physical performance battery (SPPB) scores were recruited and randomly assigned to a crossover-design study exploring feasibility and safety of semi-recumbent vibration exercise in older adults living in one RCAC. The primary outcomes were retention and adherence rates and adverse events. Results: The retention rate was 78%. Adherence rate was 79.7% and 78.6% during the vibration and control training sessions, respectively. Thirty-eight adverse events (AEs) occurred. Mild muscle soreness and knee pain were the only AEs related to vibration exercise. No serious adverse events (SAEs) were study-related. Participants were able to increase training intensity and load and rated the training enjoyable. Conclusion: Semi-recumbent vibration exercise was feasible, well tolerated, and safe in RCAC residents with reduced physical function. Future studies need to examine the effect of this type of exercise on physical function, mobility, falls, and quality of life.

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4870-4870 ◽  
Author(s):  
Ashley E. Rosko ◽  
Sarah A Wall ◽  
Carolyn Presley ◽  
ReNea Owens ◽  
Desiree Jones ◽  
...  

Abstract Background: Exercise programs are proven to positively impact physical fitness, quality of life, and late toxicities in cancer patients, and many recent reports document the benefit of exercise in patients with diverse cancers.1-3 However, such programs are underutilized in patients with hematologic malignancy.2,3 As anemia and thrombocytopenia associated with hematologic diseases are risk factors for falls and bleeding complications, exercise has not been routinely recommended. Thus, exercise programs have yet to gain traction in patients with hematologic malignancy and are rarely seen as a preventative measure for functional decline. Of critical importance, functional decline is not an inevitable part of illness or aging and is potentially modifiable.4,5 Here, we identified older adults with functional decline and incorporated a preventative exercise program to attenuate complications associated with disease- and therapy-related de-conditioning. Methods: This is a single center, pilot prospective study of older adults (≥60 years) with hematologic malignancy actively receiving chemotherapy. Patients enrolled had mild or moderate impairments in physical function, as defined by a score ≤9 on the Short Physical Performance Battery (SPPB). The SPPB is an objective, validated tool used to capture at risk patients and has been shown to be prognostic in predicting decline in function, re-hospitalization, and mortality.6 The primary objective was to assess the feasibility of implementing a structured exercise program; including recruitment and retention, adherence, sustainability, adverse events and implementation challenges. Reasons why patients decline exercise participation were also tracked. The Otago Exercise Program (OEP) has been found to be an effective exercise regimen to improve functional balance, muscle strength, and prevent fall-related injury and mortality.8 The OEP is a structured combination of physical therapist prescribed individualized exercise plans with home-based exercise, demonstrated to improve balance and functional decline.9 The OEP focuses on strengthening, balance retraining, and walking. Results: Older adults actively receiving chemotherapy with a median age of 75.5 (62-83) with hematologic malignancy (myeloma=18, NHL=6, leukemia=5) were enrolled. Chemotherapy regimens were variable (e.g. R-EPOCH, venetoclax, IMiDS, proteasome inhibitors, bone marrow transplant). Patients were approached (n=63) for participation of a structured exercise program and a target accrual of n=30 was achieved over 17 months. Reasons for declining participation included travel (n=13), inconvenience (n=12), not appropriate (n=5) or concern for side effects/cost/uninformed (n=3). There was no relationship with distanced traveled and exercise completion, R=-0.01 (p=0.94). Adherence was excellent with all 8 sessions complete (n=18) or 7 sessions complete (n=4), at time of analysis. Geriatric assessment factors were analyzed at baseline (Visit 1) and following 4 months of exercise (Visit 2). Physical health scores as measured by the MOS-PFS increased significantly [MOS-PFS: V1=55 (0-100), V2=67.5 (30-100), p=0.005], where patient reported KPS were similar [KPS V1=80 (40-100), V2=85 (60-100), p=0.065]. Importantly, objective measures of physical function improved to normal scores by visit 2 [SPPB V1=7(0-11), V2=11(2-12), p<0.001]. Moreover, quality of life scores by PROMIS demonstrated improvement in physical health symptoms. No adverse events were attributable to exercise. Conclusions: In this pilot study evaluating a structured exercise program for older adults undergoing chemotherapy, physical deficits normalized for patients, resulting in improved subjective and objective measurements of functional capacity. The program was feasible, sustainable and adherence was optimal. Here we demonstrate that exercise programs can attenuate complications associated with disease- and therapy-related de-conditioning and are feasible in older adults. Disclosures No relevant conflicts of interest to declare.


2020 ◽  
Vol 17 (7) ◽  
pp. 709-714
Author(s):  
Seigo Mitsutake ◽  
Ai Shibata ◽  
Kaori Ishii ◽  
Shiho Amagasa ◽  
Hiroyuki Kikuchi ◽  
...  

Background: The present study examined the cluster of domain-specific sedentary behaviors (SBs) and their associations with physical function among community-dwelling older adults to identify the target groups that require intervention for SBs. Methods: A total of 314 older adults who participated in a population-based cross-sectional survey and an on-site functional assessment in Matsudo City in Chiba participated in this study. Participants were asked to report the daily average of 6 domain-specific SBs. To identify the cluster of domain-specific SBs, hierarchical cluster analysis was performed using the Ward method. Analysis of covariance adjusted for sociodemographic factors, exercise habit, chronic disease, and total SB time was performed to examine the associations between each cluster and physical functional status. Results: The average age of the participants was 74.5 (5.2) years. The 4 clusters identified were leisure cluster, low cluster, work and personal computer use cluster, and television viewing cluster. The analysis of covariance adjusted for covariates showed that grip strength (P = .01), maximum walking speed (P = .03), and 1-leg standing time (P = .03) were significantly poorer in the television viewing cluster than other clusters. Conclusions: It has been concluded that the television viewing group identified as a high-risk group of physical functional decline; therefore, interventions targeting this group are needed to prevent physical functional decline.


2020 ◽  
Vol 49 (4) ◽  
pp. 580-587
Author(s):  
Claire Murphy ◽  
Adam H Dyer ◽  
Brian Lawlor ◽  
Sean P Kennelly ◽  

Abstract Aim Potentially inappropriate medication (PIM) use is prevalent in older adults and is associated with adverse events, hospitalisation and mortality. We assessed the patterns and associations of PIM use in older adults with mild-to-moderate Alzheimer’s Disease (AD), who may represent a particularly vulnerable group. Design Analysis of data from NILVad, an 18-month Randomised Control Trial of Nilvadapine in mild-to-moderate AD. The v2 STOPP criteria were applied in duplicate to identify PIM use. Associations between PIM use and adverse events/unscheduled healthcare visits in addition to the associations between PIM use and AD progression were evaluated. Setting and Participants 448 older adults with mild-to-moderate AD from 23 centres in nine European countries. Results Of 448 participants (mean age: 72.56 ± 8.19 years), over half (55.8%) were prescribed a PIM with 30.1% being prescribed 2+ PIMs. The most frequent PIMs were (i) long-term benzodiazepines (11.6% N = 52/448), (ii) selective serotonin reuptake inhibitors without appropriate indication (11.1% N = 50/448), and (iii) Proton-Pump Inhibitors (PPIs) without appropriate indication (10.7% N = 48/448). Increasing number of PIMs was associated with a greater risk of adverse events (IRR 1.17, 1.13–1.19, P &lt; 0.001), serious adverse events (IRR 1.27; 1.17–1.37, P &lt; 0.001), unscheduled hospitalisations (IRR 1.16, 1.03–1.30, P = 0.016) and GP visits (IRR 1.22, 1.15–1.28, P &lt; 0.001). PIM use was not associated with dementia progression. Conclusions and Implications PIM use is highly prevalent in mild-to-moderate AD and is associated with adverse events and unscheduled healthcare utilisation. Further attention to de-prescribing in this vulnerable group is warranted.


2020 ◽  
Vol 32 (12) ◽  
pp. 2565-2585 ◽  
Author(s):  
Justin Avery Aunger ◽  
Colin J. Greaves ◽  
Edward T. Davis ◽  
Evans Atiah Asamane ◽  
Anna C. Whittaker ◽  
...  

Abstract Background Osteoarthritis is a prevalent condition in older adults that causes many patients to require a hip or knee replacement. Reducing patients’ sedentariness prior to surgery may improve physical function and post-operative outcomes. Methods We conducted a pragmatic randomised-controlled feasibility study with 2:1 allocation into intervention or usual care groups. The intervention, based on Self-Determination Theory, involved techniques to reduce sedentary behaviour, including motivational interviewing, setting of behavioural goals, and more. The primary outcome was feasibility, assessed using mixed methods. We included exploratory measures to inform a future definitive trial, such as ActivPal3 accelerometry to measure movement, the Short Physical Performance Battery (SPPB), Basic Psychological Needs, and cardiometabolic biomarkers. Assessments were at baseline, 1-week pre-surgery, and 6-week post-surgery. Results We recruited 35 participants aged ≥ 60 years approximately 8 weeks before hip or knee arthroplasty. Participant uptake rate was 14.2%, and retention rate 85.7%. Participants were very satisfied with the study which was found to be feasible with some modifications. Exploratory within-group comparisons found that the intervention has potential to improve SPPB by 0.71 points from baseline to pre-surgery, a clinically significant increase, and reduce sedentary time by up to 66 min d−1. Conclusion In this older surgical population, it is feasible to use behavioural techniques to displace sedentary time to activity and to conduct a trial spanning the period of surgical intervention. This may improve physical function and surgical outcomes. The INTEREST intervention is now ready for evaluation in a full-scale randomised-controlled trial. Registration This trial was registered on Clinicaltrials.gov on 13/11/2018. ID: NCT03740412.


2020 ◽  
Author(s):  
Amy Gladin ◽  
Wendy Katzman ◽  
Yoshimi Fukuoka ◽  
Neeta Parimi ◽  
Shirley Wong ◽  
...  

Abstract Background: Hyperkyphosis is common in older adults and associated with low physical function and reduced health related quality of life (HrQol). Improved kyphosis has been previously established in kyphosis-targeted interventions in randomized controlled trials in older adults with hyperkyphosis however evidence for improved physical function is conflicting. Few studies have investigated change in physical function after a targeted kyphosis intervention in older adults with low physical function. The primary aim in this descriptive study was to explore change in physical function after a progressive high intensity 3-month targeted kyphosis exercise and posture training intervention in older adults with low physical function and hyperkyphosis. Secondary aims were to explore change in HrQol, spinal strength and spinal curvature, and adherence and safety of the intervention in older adults with low physical function and hyperkyphosis.Methods: In this secondary analysis of the Specialized Center of Research (SCOR) Kyphosis randomized trial, 101 community dwelling older men and women with hyperkyphosis who completed the intervention were divided into a low function group (LFG) and high function group (HFG). Baseline characteristics were compared between LFG and HFG. Physical function, HrQol, spinal strength and spinal curvature (kyphosis and lordosis) pre/post intervention change scores were explored within and between groups. Adherence and adverse events were examined in the LFG and HFG. Results:Twenty-six (26%) older adults were LFG, mean SPPB 9.62 (SD=1.17) points. At baseline, the LFG was older than HFG (p=0.005), endorsed more pain, (p=0.060), had worse physical function and HrQol (p≤0.001), and comparable kyphosis (p=0.640). SPPB increased 0.62 (95% CI: -0.20 to 1.44) points in the LFG and decreased 0.04 (95%CI: -0.28 to 0.19) points in the HFG, p=0.020. Gait speed improved 0.04 (95%CI: -0.02 to 0.10) m/s in the LFG. Kyphosis improved equally in both groups. Adherence was similar and there were no adverse events in the LFG or HFG. Conclusions:Older adults with low physical function and hyperkyphosis may improve physical function after a kyphosis targeted intervention. Older adults with low physical function may safely participate in targeted high-intensity kyphosis exercise and posture training. This observation needs to be confirmed in larger adequately powered studies. Clinicaltrials.gov dentifier: NCT01766674


Author(s):  
Siobhan Gee ◽  
David Taylor

Clozapine is licensed in the UK for use in treatment-resistant schizophrenia, treatment-intolerant schizophrenia, or psychosis associated with Parkinson’s disease. As with many drugs, it is also used outside of these licensing parameters for other conditions or clinical situations—often referred to as ‘off-label’ prescribing. These off-label indications have varying degrees of theoretical support, peer-reviewed evidence, and practical experience associated with them. This chapter discusses the use of clozapine for children and adolescents, older adults, and in the treatment of aggression and mood disorders. The use of supramaximal doses of clozapine to achieve therapeutic plasma concentrations is also off-label, although adding interacting medication to reach the same result is not; these contrasting approaches are also debated. Finally, rechallenging with clozapine in patients who have previously had serious adverse events to the drug is also considered.


2020 ◽  
Vol 222 (6) ◽  
pp. 979-988 ◽  
Author(s):  
Kristi Williams ◽  
Arangassery Rosemary Bastian ◽  
Robert Allen Feldman ◽  
Edmund Omoruyi ◽  
Els de Paepe ◽  
...  

Abstract Background Despite the high disease burden of respiratory syncytial virus (RSV) in older adults, there is no approved vaccine. We evaluated the experimental RSV vaccine, Ad26.RSV.preF, a replication-incompetent adenovirus 26 vector encoding the F protein stabilized in prefusion conformation. Methods This phase 1 clinical trial was performed in healthy adults aged ≥60 years. Seventy-two participants received 1 or 2 intramuscular injections of low-dose (LD; 5 × 1010 vector particles) or high-dose (HD; 1 × 1011 vector particles) Ad26.RSV.preF vaccine or placebo, with approximately 12 months between doses and 2-year follow-up for safety and immunogenicity outcomes. Results Solicited adverse events were reported by 44% of vaccine recipients and were transient and mild or moderate in intensity. No serious adverse events were related to vaccination. After the first vaccination, geometric mean titers for RSV-A2 neutralization increased from baseline (432 for LD and 512 for HD vaccine) to day 29 (1031 for LD and 1617 for HD). Pre-F–specific antibody geometric mean titers and median frequencies of F-specific interferon γ–secreting T cells also increased substantially from baseline. These immune responses were still maintained above baseline levels 2 years after immunization and could be boosted with a second immunization at 1 year. Conclusions Ad26.RSV.preF (LD and HD) had an acceptable safety profile and elicited sustained humoral and cellular immune responses after a single immunization in older adults.


2015 ◽  
Vol 75 (6) ◽  
pp. 1081-1091 ◽  
Author(s):  
Gerd R Burmester ◽  
William F Rigby ◽  
Ronald F van Vollenhoven ◽  
Jonathan Kay ◽  
Andrea Rubbert-Roth ◽  
...  

ObjectivesThe efficacy of tocilizumab (TCZ), an anti-interleukin-6 receptor antibody, has not previously been evaluated in a population consisting exclusively of patients with early rheumatoid arthritis (RA).MethodsIn a double-blind randomised controlled trial (FUNCTION), 1162 methotrexate (MTX)-naive patients with early progressive RA were randomly assigned (1:1:1:1) to one of four treatment groups: 4 mg/kg TCZ+MTX, 8 mg/kg TCZ+MTX, 8 mg/kg TCZ+placebo and placebo+MTX (comparator group). The primary outcome was remission according to Disease Activity Score using 28 joints (DAS28–erythrocyte sedimentation rate (ESR) <2.6) at week 24. Radiographic and physical function outcomes were also evaluated. We report results through week 52.ResultsThe intent-to-treat population included 1157 patients. Significantly more patients receiving 8 mg/kg TCZ+MTX and 8 mg/kg TCZ+placebo than receiving placebo+MTX achieved DAS28-ESR remission at week 24 (45% and 39% vs 15%; p<0.0001). The 8 mg/kg TCZ+MTX group also achieved significantly greater improvement in radiographic disease progression and physical function at week 52 than did patients treated with placebo+MTX (mean change from baseline in van der Heijde–modified total Sharp score, 0.08 vs 1.14 (p=0.0001); mean reduction in Health Assessment Disability Index, −0.81 vs −0.64 (p=0.0024)). In addition, the 8 mg/kg TCZ+placebo and 4 mg/kg TCZ+MTX groups demonstrated clinical efficacy that was at least as effective as MTX for these key secondary endpoints. Serious adverse events were similar among treatment groups. Adverse events resulting in premature withdrawal occurred in 20% of patients in the 8 mg/kg TCZ+MTX group.ConclusionsTCZ is effective in combination with MTX and as monotherapy for the treatment of patients with early RA.Trial registration numberClinicalTrials.gov, number NCT01007435


2021 ◽  
pp. 1-16
Author(s):  
Albert C. Lo ◽  
Cynthia Duggan Evans ◽  
Michele Mancini ◽  
Hong Wang ◽  
Sergey Shcherbinin ◽  
...  

Background: LY3202626 is a small molecule inhibitor of β-site amyloid precursor protein cleaving enzyme (BACE)1 shown to reduce amyloid-β (Aβ)1–40 and Aβ1–42 concentrations in plasma and cerebrospinal fluid developed for the treatment of Alzheimer’s disease (AD). Objective: To assess the change from baseline in flortaucipir positron emission tomography (PET) after treatment with LY3202626 compared with placebo in patients with mild. Methods: Patients received daily 3 mg or 12 mg doses of LY3202626 or placebo for 52 weeks. The primary outcome was assessment of cerebral neurofibrillary tangle load by flortaucipir PET. The study was terminated early following an interim analysis due to a low probability of identifying a statistically significant slowing of cognitive and/or functional decline. Results: A total of 316 patients were randomized and 47 completed the study. There was no statistically significant difference between placebo and either dose of LY3202626 from baseline to 52 weeks, or in annualized change for flortaucipir PET. There was no clinically meaningful difference between placebo and LY3202626 doses on efficacy measures of cognition and function. No deaths or serious adverse events considered related to LY3202626 were reported. A statistically significant increase in treatment-emergent adverse events in the psychiatric disorders system organ class was reported for both LY3202626 doses compared to placebo. Conclusion: LY3202626 tested at doses generating 70–90% BACE inhibition was generally well tolerated in this study. LY3202626 treatment did not result in a clinically significant change in cerebral tau burden as measured by flortaucipir nor in change of functional or cognitive decline compared to placebo.


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