BackgroundElderly people have high rates of functional decline, which compromises independence, self-confidence, and quality of life (QoL). Physical exercise leads to significant improvements in strength, balance, functional mobility, and QoL, but there is still reduced access to this therapeutic strategy due to difficulties in locomotion to training centers or lack of adaptation to the exercise environment.Methods/designThe purpose of this clinical trial will be to verify the effect of a progressive and semi-supervised, home-based exercise program on the functional mobility, and in the QoL of sedentary elderly people. This is a protocol of a consecutive, single-center, single-blind, and randomized controlled trial. The design, conduct, and report follows the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Sedentary elderly people will be enrolled, and randomly allocated into two groups. The intervention group will perform exercises in their own home and the control group will not perform exercises. The evaluations will occur at study enrollment and after 3 months of intervention, and will be performed using the functional mobility Timed Up & Go (TUG) test and sociodemographic and QoL questionnaires. In the statistical analysis, comparisons of mean and correlation analyses will be performed. The primary expected outcome is the improvement in functional mobility verified through the TUG test and the secondary outcome is the improvement in QoL verified by the WHOQOL-OLD.DiscussionThe lack of scientific evidence demonstrating the benefits of semi-supervised home exercise on functional mobility and QoL in elderly people represents an obstacle to the development of guidelines for clinical practice and for policy-makers. The World Health Organization highlighted the importance of musculoskeletal health programs for elderly people, and the exercise program described in this protocol was designed to be viable, easy to implement, and inexpensive, and could be performed at the home of elderly subjects after receiving only guidelines and follow-up via periodic visits. Based on these facts, we hope that this study will demonstrate that a well-structured, home-based exercise program can be effective in improving functional mobility and QoL of sedentary elderly people, even without constant supervision during exercise.Trial registrationRegistro Brasileiro de Ensaios Clínicos (ReBEC), Identifier: RBR-3cqzfy. Registered on 2 December 2016.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-3061-1) contains supplementary material, which is available to authorized users.
BackgroundObesity is a major public health problem in both developed and developing countries alike and leads to a series of changes in respiratory physiology. There is a strong correlation between obesity and cardiopulmonary sleep disorders. Weight loss among such patients leads to a reduction in these alterations in respiratory physiology, but clinical treatment is not effective for a long period of time. Thus, bariatric surgery is a viable option.Methods/DesignThe present study involves patients with morbid obesity (BMI of 40 kg/m2 or 35 kg/m2 to 39.9 kg/m2 with comorbidities), candidates for bariatric surgery, screened at the Santa Casa de Misericórdia Hospital in the city of Sao Paulo (Brazil). The inclusion criteria are grade III morbid obesity, an indication for bariatric surgery, agreement to participate in the study and a signed term of informed consent. The exclusion criteria are BMI above 55 kg/m2, clinically significant or unstable mental health concerns, an unrealistic postoperative target weight and/or unrealistic expectations of surgical treatment. Bariatric surgery candidates who meet the inclusion criteria will be referred to Santa Casa de Misericórdia Hospital and will be reviewed again 30, 90 and 360 days following surgery. Data collection will involve patient records, personal data collection, objective assessment of HR, BP, neck circumference, chest and abdomen, collection and analysis of clinical preoperative findings, polysomnography, pulmonary function test and a questionnaire on sleepiness.DiscussionThis paper describes a randomised controlled trial of morbidly obese patients. Polysomnography, respiratory mechanics, chemosensitive response and quality of life will be assessed in patients undergoing or not undergoing bariatric surgery.Trial RegistrationThe protocol for this study is registered with the Brazilian Registry of Clinical Trials - ReBEC (RBR-9k9hhv).
BackgroundObstructive sleep apnea (OSA) is a respiratory disease characterized by the collapse of the extrathoracic airway and has important social implications related to accidents and cardiovascular risk. The main objective of the present study was to investigate whether the drop in expiratory flow and the volume expired in 0.2 s during the application of negative expiratory pressure (NEP) are associated with the presence and severity of OSA in a population of professional interstate bus drivers who travel medium and long distances.Methods/DesignAn observational, analytic study will be carried out involving adult male subjects of an interstate bus company. Those who agree to participate will undergo a detailed patient history, physical examination involving determination of blood pressure, anthropometric data, circumference measurements (hips, waist and neck), tonsils and Mallampati index. Moreover, specific questionnaires addressing sleep apnea and excessive daytime sleepiness will be administered. Data acquisition will be completely anonymous. Following the medical examination, the participants will perform a spirometry, NEP test and standard overnight polysomnography. The NEP test is performed through the administration of negative pressure at the mouth during expiration. This is a practical test performed while awake and requires little cooperation from the subject. In the absence of expiratory flow limitation, the increase in the pressure gradient between the alveoli and open upper airway caused by NEP results in an increase in expiratory flow.DiscussionDespite the abundance of scientific evidence, OSA is still underdiagnosed in the general population. In addition, diagnostic procedures are expensive, and predictive criteria are still unsatisfactory. Because increased upper airway collapsibility is one of the main determinants of OSA, the response to the application of NEP could be a predictor of this disorder. With the enrollment of this study protocol, the expectation is to encounter predictive NEP values for different degrees of OSA in order to contribute toward an early diagnosis of this condition and reduce its impact and complications among commercial interstate bus drivers.Trial registrationRegistro Brasileiro de Ensaios Clinicos (local acronym RBEC) [Internet]: Rio de Janeiro (RJ): Instituto de Informaçao Cientifica e Tecnologica em Saude (Brazil); 2010 - Identifier RBR-7dq5xx. Cross-sectional study on efficacy of negative expiratory pressure test proposed as screening for obstructive sleep apnea syndrome among commercial interstate bus drivers; 2011 May 31 [7 pages]. Available from http://www.ensaiosclinicos.gov.br/rg/RBR-7dq5xx/.
IntroductionFunctional alterations of the cystic fibrosis transmembrane conductance regulator gene (CFTR) increase the viscoelasticity of pulmonary secretions of cystic fibrosis (CF) patients and require the use of therapeutic aerosols. The biochemical properties of exocrine secretions are influenced by the expression of the FUT2 gene which determine the secretor and non-secretor phenotypes of the ABH glycoconjugates. The aim of this study was to determine the influence of secretor and non-secretor phenotypes by means of photoacoustic analysis, both the typical interaction time (t 0) and the solubilization interval (Δt) of the sputum of secretor and non-secretor CF patients nebulized by hypertonic saline solutions at different concentrations.Material and methodsSputum samples were obtained by spontaneous expectoration from 6 secretor and 4 non-secretor patients with CF. Each sample was nebulized with 3%, 6%, and 7% hypertonic saline solutions in a photoacoustic cell. The values of t 0 and Δt were determined using the Origin 7.5® computer program (Microcal Software Inc.). The t-test was employed using the GraphPad Instat 3.0® computer program to calculate the mean and standard deviation for each parameter.ResultsFor all hypertonic saline solutions tested, the mean values of t 0 and Δt do not show statistically significant differences between secretor and non-secretor patients.ConclusionsThe secretor and non-secretor phenotypes do not influence the in vitro solubilization of the sputum nebulized by hypertonic saline solutions at different concentrations when analysed by photoacoustic technique.
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