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Resistance training has a positive impact on functional capacity and muscle mass in the elderly. However, due to physical limitations or a simple aversion against regular exercise, a majority of the elderly do not reach the recommended exercise doses. This led us to evaluate the effect of whole-body electromyostimulation (WB-EMS), a novel, time-efficient, and smooth training technology on physical function, fat-free mass, strength, falls-efficacy, and social participation of the elderly. The present study is a randomized, parallel group clinical trial approved by the Ethics Committee of our Institution. Sixty-six volunteers (age ≥ 60 years) will be recruited from the geriatric outpatient department in a tertiary hospital and primary care units and randomized into two groups: WB-EMS group or active control group (aCG). The WB-EMS or aCG protocol will consist of 16 sessions for 8 consecutive weeks, twice per week. The primary outcomes will be maximal isometric knee extension (IKE), functional lower extremity strength, fat-free mass, gait speed, and risk of falls measured before and after intervention. The secondary outcomes will be social participation and falls-efficacy assessed before and after the intervention and at three and six months of follow-up. Participant's satisfaction with and awareness of electrical stimulation therapy will also be assessed immediately after the 8-week intervention. Patients receiving WB-EMS exercises are believed to have better outcomes than those receiving conventional, more time-consuming resistance exercises. Hence, innovative, time-efficient, joint-friendly, and highly individualized exercise technologies (such as WB-EMS) may be a good choice for the elderly with time constraints, physical limitations, or little enthusiasm, who are exercising less than the recommended amounts for impact on muscle mass, strength, and function.

Participation of older people in a program of regular exercise is an effective strategy to minimize the physical decline associated with age. The purpose of this study was to assess adherence rates in older women enrolled in two different exercise programs (one aerobic exercise and one strength training) and identify any associated clinical or functional factors. This was an exploratory observational study in a sample of 231 elderly women of mean age 70.5 years. We used a structured questionnaire with standardized tests to evaluate the relevant clinical and functional measures. A specific adherence questionnaire was developed by the researchers to determine motivators and barriers to exercise adherence. The adherence rate was 49.70% in the aerobic exercise group and 56.20% in the strength training group. Multiple logistic regression models for motivation were significant (P=0.003) for the muscle strengthening group (R(2)=0.310) and also significant (P=0.008) for the aerobic exercise group (R(2)=0.154). A third regression model for barriers to exercise was significant (P=0.003) only for the muscle strengthening group (R(2)=0.236). The present study shows no direct relationship between worsening health status and poor adherence. Factors related to adherence with exercise in the elderly are multifactorial.

PurposeTo conduct a systematic review about risk factors associated with non-specific low back pain (LBP) in older people.MethodsThe study protocol was prospectively registered with Prospero (CRD42020191619). This systematic review with meta-analysis included cohort studies that investigated risk factors for LBP in older people. The following databases were searched up to 12 December 2020: MEDLINE (Ovid), Embase, CINAHL, SCOPUS and Web of Science. Two independent reviewers appraised methodological quality using the Critical Appraisal Checklist for Cohort Studies instrument.ResultsWe identified 3939 potentially relevant publications. After removing duplicates, screening title, and abstracts, we assessed 86 publications in full text. We included the remaining 11 publications for analysis. There is strong evidence that depressive symptoms are a risk of reporting future back pain onset (I2 = 52,7%, Odds ratio 1.4, CI 1.28–1.53).ConclusionDepressive symptoms are a risk factor for LBP in older people. Due to the limitations of the literature, the role of some risk factors remains unclear. An additional high-quality prospective cohort is needed to better elucidate these relationships.

Background The prognosis of back pain (BP) in the older adults is less favorable than in younger adults and progress to adverse outcomes and consequent worsening of health-related quality of life (HRQoL). The present study aimed to verify the association between BP intensity, disability and HRQoL in older adults residents in Brazil and Netherlands, and to evaluate whether the country of residence influences the associations. Methods Data were collected from 602 Brazilian and 675 Dutch participants with a new episode of BP from the Back Complaints in Elders (BACE) consortium. For the present study, a cross section was used. Pain intensity and disability were assessed using the Numerical Rating Scale (NRS) and the Roland-Morris Disability Questionnaire (RMDQ), respectively. HRQoL was assessed using the Short Form Health Survey (SF-36) quality of life questionnaire. Age, sex, and education were descriptive variables. Pain intensity (NPS score) and country were the independent variables and quality of life assessed by each SF domain − 36 was the dependent variable. Analysis of models at the individual level was performed to verify the association between pain and disability, also HRQoL in Netherlands and Brazil in the total sample. The multilevel model was used to verify whether the older adults person’s country of residence influenced this relationship. Results The average age of the participants was 67.00 (7.33) years. In the total sample, linear regression analysis adjusted for sex and age showed a significant association between BP intensity scores and HRQoL, for all domains. There was no association between disability and HRQoL. In the multilevel analysis, there was an association between BP intensity and HRQoL in all domains and an association between the country of residence and HRQoL, influencing the effect of pain, in all domains, except for the physical functioning. Conclusion Socioeconomic and cultural aspects of different countries can affect the perception of the elderly about their HRQoL in the presence of BP. Pain and disability in Brazilian and Dutch older adults ones are experienced differently in relation to their HRQoL.

Background Aging is associated with chronic low-grade inflammatory activity with an elevation of cytokine levels. An association between regular physical activity and reduction of blood levels of anti-inflammatory cytokines is demonstrated in the literature pointing to an anti-inflammatory effect related to exercise. However, there is no consensus regarding which type of exercise and which parameters are the most appropriate to influence inflammatory markers. Evidence indicates that the single nucleotide polymorphism (SNP) can influence the synthesis of those cytokines affecting their production. Methods/Design The design of this study is a randomized controlled trial. The aim of this study is to investigate the interaction between the cytokine genes SNP and the effect of physical activity on older women. The main outcomes are: serum levels of sTNFR-1, sTNFR-2, interleukin (IL)-6, IL-10, measured by the ELISA method; genotyping of tumor necrosis factor- (TNF)-alpha (rs1800629), IL6 (rs1800795), IL10 (rs1800896) by the TaqMan Method (Applied Biosystems, Foster City, CA, USA); and physical performance assessed by Timed Up and Go and 10-Meter Walk Tests. Secondary outcomes include: Geriatric Depression Scale, Perceived Stress Scaleand aerobic capacity, assessed by the six-minute walk; and lower limb muscle strength, using an isokinetic dinamometer (Biodex Medical Systems, Inc., Shirley, NY,USA). Both exercise protocols will be performed three times a week for 10 weeks, 30 sessions in total. Discussion Investigating the interaction between genetic factors and exercise effects of both protocols of exercise on the levels of inflammatory cytokine levels can contribute to guide clinical practice related to treatment and prevention of functional changes due to chronic inflammatory activity in older adults. This approach could develop new perspectives on preventive and treatment proposals in physical therapy and in the management of the older patient. Trial registration (ReBEC) RBR9v9cwf

PurposeTo investigate the association between plasma levels of inflammatory cytokines (interleukin [IL]-1-β, IL-6, tumor necrosis factor [TNF]-α, and the soluble TNF receptor 1 [sTNF-R1]), disability, and risk of falls in older women with acute low back pain (LBP).MethodsThis cross-sectional study comprised a subsample of older women from the Back Complaints in the Elders international cohort study. Plasma levels of IL-1-β, IL-6, TNF-α, and sTNF-R1 were measured using enzyme-linked immunosorbent assays. Pain was assessed using the Numerical Pain Scale and McGill Pain Questionnaire, while disability was measured using the Roland Morris Questionnaire and gait speed. Risk of falls was estimated using the Physiological Profile Assessment. Linear regression model was used to verify the association between independent variables and fall risk.ResultsOne hundred and ten women (aged 69.97 ± 5.5 years) with acute LBP were included. The regression model showed an association between the risk of falls and IL-6 levels, pain, gait speed, and years of education. It also explained 21.2% of risk of falls variance. The model equation was: fall risk = 1.28 + (0.19 IL-6) + (0.02 quality of pain) + (− 0.71 gait speed) + (−0 .17 educational level).ConclusionsThis study showed an association between risk of falls and IL-6, pain, gait speed, and educational level in older women with LBP.Graphic abstractThese slides can be retrieved under Electronic Supplementary Material.

This cross-sectional study evaluated the association of biopsychosocial factors with disability in older adults with a new episode of acute low back pain. Older patients with a new episode of acute low back pain were included and those with cognitive alterations and severe motor impairment were excluded. Disability was assessed using the Roland Morris Disability Questionnaire. The biopsychosocial factors (clinical, functional, health status, psychological and social variables) were evaluated by a structured multidimensional questionnaire and physical examination. A multivariate linear regression was used to analyze data with a statistical significance of 0.05. A total of 386 older individuals with a mean age of 71.6 (± 4.2) years and disability of 13.7 (± 5.7) points were enrolled. Our regression analyses identified that worse physical and mental health (assessed through SF-36), low falls self-efficacy, trouble sleeping due to pain, worse kinesiophobia levels, higher body mass indexes, lumbar morning stiffness, increased pain intensity, female gender and worse functional mobility were significantly associated with baseline disability (p < 0.05). Low back pain-related disability is significantly associated with worse biopsychosocial health conditions in older adults.

High levels of inflammatory mediators are associated with reduced physical capabilities and muscle function in the elderly. Single nucleotide polymorphisms (SNPs) may affect the expression and synthesis of these molecules, thus influencing the intensity of the inflammatory response and susceptibility to certain diseases. Physical exercise may attenuate age-related chronic inflammation and improve physical performance. This study evaluated the interaction between the SNP rs1800629 in TNF-α, rs1800795 in IL6, and rs1800896 in IL10 and the effect of physical exercise on physical performance and inflammation in elderly women. There was a significant interaction between rs1800629 and the effect of exercise on physical performance and between the combined 3-SNP genotype and changes in physical performance in response to exercise. These SNPs did not influence the effect of exercise on inflammatory parameters. Elderly women with a combination of genotypes associated with an anti-inflammatory profile (low TNF-α and IL-6 production, high IL-10 production) showed better physical performance independent of exercise modality, evidence of an interactive influence of genetic and environmental factors on improving physical performance in elderly women.

Resumo Este estudo transversal avaliou a associação de fatores biopsicossociais com a incapacidade em idosos com um novo episódio de dor lombar aguda. Foram incluídos idosos com um novo episódio de dor lombar aguda e excluídos aqueles com alterações cognitivas e deficiências motoras graves. A incapacidade foi avaliada pelo Roland Morris Disability Questionnaire. Os fatores biopsicossociais (variáveis clínicas, funcionais, estado de saúde, psicológicas e sociais) foram avaliados por um questionário estruturado multidimensional e exame físico. Regressão linear multivariada foi utilizada para análise dos dados com significância estatística de 0,05. Participaram 386 idosos com média de idade de 71,6 (±4,2) anos e incapacidade de 13,7 (±5,7) pontos. A análise de regressão linear multivariada identificou que pior saúde física e mental (avaliados através do SF-36), baixa autoeficácia em quedas, dificuldade para dormir por causa da dor, piores níveis de cinesiofobia, maiores índices de massa corporal, presença de rigidez matinal na coluna lombar, maior intensidade de dor, sexo feminino e pior mobilidade funcional foram significativamente associados com incapacidade (p < 0,05). Incapacidade relacionada à dor lombar está significativamente associada com piores condições biopsicossociais de saúde em idosos. Abstract This cross-sectional study evaluated the association of biopsychosocial factors with disability in older adults with a new episode of acute low back pain. Older patients with a new episode of acute low back pain were included and those with cognitive alterations and severe motor impairment were excluded. Disability was assessed using the Roland Morris Disability Questionnaire. The biopsychosocial factors (clinical, functional, health status, psychological and social variables) were evaluated by a structured multidimensional questionnaire and physical examination. A multivariate linear regression was used to analyze data with a statistical significance of 0.05. A total of 386 older individuals with a mean age of 71.6 (± 4.2) years and disability of 13.7 (± 5.7) points were enrolled. Our regression analyses identified that worse physical and mental health (assessed through SF-36), low falls self-efficacy, trouble sleeping due to pain, worse kinesiophobia levels, higher body mass indexes, lumbar morning stiffness, increased pain intensity, female gender and worse functional mobility were significantly associated with baseline disability (p < 0.05). Low back pain-related disability is significantly associated with worse biopsychosocial health conditions in older adults.

A maioria dos fármacos resulta de processos de síntese que envolvem um conjunto complexo de reações químicas, recorrendo-se muitas vezes a reagentes altamente reativos. Como resultado desses processos surgem impurezas, incluindo as Impurezas Genotóxicas (IG), que, mesmo em níveis residuais, podem prejudicar a segurança e efetividade dos fármacos.As IG, dividindo-se entre mutagénicas e cancerígenas, podem originar graves problemas de segurança, concentrando em si uma grande preocupação por parte da Indústria Farmacêutica. Todo o sector desenvolveu esforços no sentido de otimizar o processo de controlo das mesmas, tentando ao máximo mitigar os seus possíveis efeitos.Várias normas têm sido publicadas sobre esta temática, culminando na publicação da guidelineICH M7(R1), intitulada “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potencial Carcinogenic Risk”. Esta norma, amplamente citada e analisada na presente revisão, surgiu no sentido de harmonizar os conceitos abordados nos restantes documentos disponíveis e fazer face a diversas questões levantadas na abordagem adequada a estas impurezas. Para além das orientações presentes no documento referido, a guidelineICH S2(R1) caracteriza a bateria de ensaios de curto-termo que devem ser realizados no sentido de se avaliar a genotoxicidade dos compostos e predizer potenciais riscos para a saúde humana.Um dos maiores desafios para a Indústria Farmacêutica reside no desenvolvimento e implementação de metodologias com um grau de sensibilidade e de especificidade adequado para a quantificação das IG, devendo, idealmente, permitir limites de deteção na ordem de 1 a 5 ppm. Neste contexto, diversas metodologias analíticas baseadas na Espetrometria de Massa têm sido utilizadas.Em resumo, é inequívoco afirmar que as IG trouxeram novos desafios, por vezes de grande complexidade, para a Indústria Farmacêutica, destacando-se a necessidade de existir um equilíbrio entre as exigências regulamentares e o impacto das mesmas no tempo e custo de desenvolvimento dos novos fármacos.