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1.
Trials ; 22(1): 587, 2021 Sep 03.
Artigo em Inglês | MEDLINE | ID: mdl-34479617

RESUMO

BACKGROUND: Falls are one of the most common accidents in older adults, often leading to injury, disability and quality-of-life declines. Foot core function contributes to postural stability in most static postures and dynamic activities. As efficient foot core training, the intrinsic-foot-muscle exercise has been proposed to improve postural control. However, the effects of the exercise on postural stability in the elderly remain unclear. Therefore, this study attempts to investigate the effect of 12-week intrinsic-foot-muscle exercise on postural stability in older adults with fall risk. METHODS: We will conduct a prospective, single-blind randomised controlled trail on 120 older adults with fall risk. Participants will be randomly assigned to an intrinsic-foot-muscle exercise combining the lower extremity resistance training group (IFM group), an extrinsic-foot-muscle exercise combining the lower extremity resistance training group (EFM group) and a control group. The control group will perform lower extremity resistance training. The IFM and EFM groups will be given additional short-foot exercise or towel-curl exercise training, respectively. After the intervention, participants will be followed up for another 12 weeks with no active intervention. The outcome measures will include the postural stability measurements, self-reported postural stability, number of falls, intrinsic-foot-muscle strength and foot arch function. Furthermore, adverse events will be recorded and analysed. If any participant withdraws from the trial, an intention-to-treat analysis will be performed. DISCUSSION: The trial is designed to investigate the efficacy of a 12-week intrinsic foot muscle training combined with the lower extremity resistance training on postural stability outcomes in elderly people with fall risk. The trial will also examine the comprehensive outcomes of postural stability during static standing and dynamic movements. The function of intrinsic foot muscle to support the arch will also be evaluated. Important features of this trial mainly include intervention setting, outcome measure selection and study duration. The results of this study will determine the effectiveness and provide scientific evidence to establish comprehensive fall prevention intervention. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000033623. Registered on 7 June 2020. http://www.chictr.org.cn/showproj.aspx?proj=54741.


Assuntos
Treinamento de Força , Acidentes por Quedas/prevenção & controle , Idoso , Exercício Físico , Terapia por Exercício , , Humanos , Músculo Esquelético , Equilíbrio Postural , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Método Simples-Cego
2.
J Int Med Res ; 49(9): 3000605211039564, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34486432

RESUMO

OBJECTIVE: To investigate the changes in serum growth hormone (GH), testosterone, and insulin-like growth factor 1 (IGF-1) during low-intensity resistance exercise under different cuff pressures. METHODS: We performed a single-blind, cross-over design study. Twenty-five healthy young men performed three exercise protocols as follows: 1) no blood flow restriction exercise (control group), 2) resistance exercise at 40% of arterial occlusion pressure (AOP) (low group), and 3) resistance exercise at 70% of AOP (high group). Blood lactate, GH, testosterone, and IGF-1 levels were measured at four time points. RESULTS: There were no differences in the indices before exercise. The blood flow restriction exercise under different pressures had different effects on each index and there was an interactive effect. GH levels were significantly higher in the high group than in the other groups after exercise. Immediately after exercise, IGF-1 and testosterone levels were significantly higher in the high group than in the other groups. At 15 minutes after exercise, testosterone levels were significantly higher in the high group than in the other groups. CONCLUSIONS: Low-intensity resistance exercise combined with blood flow restriction effectively increases GH, IGF-1, and testosterone levels in young men. Increasing the cuff pressure results in greater levels of hormone secretion.


Assuntos
Hormônio do Crescimento , Hormônio do Crescimento Humano , Exercício Físico , Humanos , Fator de Crescimento Insulin-Like I , Masculino , Método Simples-Cego , Testosterona
3.
Medicine (Baltimore) ; 100(35): e26918, 2021 Sep 03.
Artigo em Inglês | MEDLINE | ID: mdl-34477122

RESUMO

BACKGROUND: Radical pancreaticoduodenectomy is the only possible cure for pancreatic head adenocarcinoma, and although several RCT studies have suggested the extent of lymph node dissection, this issue remains controversial. This article wanted to evaluate the survival benefit of different lymph node dissection extent for radical surgical treatment of pancreatic head adenocarcinoma. METHODS: A total of 240 patients were assessed for eligibility in the study, 212 of whom were randomly divided into standard lymphadenectomy group (SG) or extended lymphadenectomy group (EG), there were 97 patients in SG and 95 patients in EG receiving the radical pancreaticoduodenectomy. RESULT: The demography, histopathology and clinical characteristics were similar between the 2 groups. The 2-year overall survival rate in the SG was higher than the EG (39.5% vs 25.3%; P = .034). The 2-year overall survival rate in the SG who received postoperative adjuvant chemotherapy was higher than the EG (60.7% vs 37.1%; P = .021). There was no significant difference in the overall incidence of complications between the 2 groups (P = .502). The overall recurrence rate in the SG and EG (70.7% vs 77.5%; P = .349), and the patterns of recurrence between 2 groups were no significant differences. CONCLUSION: In multimodality therapy system, the efficacy of chemotherapy should be based on the appropriate lymphadenectomy extent, and the standard extent of lymphadenectomy is optimal for resectable pancreatic head adenocarcinoma. The postoperative slowing of peripheral blood lymphocyte recovery might be 1 of the reasons why extended lymphadenectomy did not result in survival benefits. CLINICAL TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov (NCT02928081) in October 7, 2016. https://clinicaltrials.gov/.


Assuntos
Adenoma/cirurgia , Excisão de Linfonodo/normas , Neoplasias Pancreáticas/cirurgia , Adenoma/epidemiologia , Adenoma/mortalidade , Idoso , Distribuição de Qui-Quadrado , Feminino , Humanos , Excisão de Linfonodo/métodos , Excisão de Linfonodo/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Neoplasias Pancreáticas/epidemiologia , Neoplasias Pancreáticas/mortalidade , Pancreaticoduodenectomia/métodos , Pancreaticoduodenectomia/normas , Pancreaticoduodenectomia/estatística & dados numéricos , Modelos de Riscos Proporcionais , Estudos Prospectivos , Método Simples-Cego
4.
Medicine (Baltimore) ; 100(35): e27067, 2021 Sep 03.
Artigo em Inglês | MEDLINE | ID: mdl-34477139

RESUMO

BACKGROUND: There is no clear information on the efficacy of corticosteroids, and splints in the treatment of patients with diabetes mellitus (DM). The aim of this study was to compare the outcomes of isolated corticosteroid injection therapy with splint treatment with corticosteroid injection in patients with and without DM. METHODS: 84 diabetics, and 84 healthy patients with a diagnosis of de Quervain's tenosynovitis were included in our study. The patients were randomly distributed into four subgroups with and without DM. Groups 1 and group 2 consisted of diabetic patients, while group 3 and group 4 consisted of healthy patients. Corticosteroid injections were administered to groups 1 and 3, and corticosteroid injection and splint treatment were administered to groups 2 and 4. RESULTS: There was no significant difference in terms of age, gender, dominant/non-dominant hand, pre-treatment Quick Disabilities of the Arm, Shoulder and Hand score and visual analog scale scores score between the four groups. Quick Disabilities of the Arm, Shoulder and Hand and visual analog scale scores in the four groups were found to be significantly better than pre-treatment at the 12th month. Finkelstein test results were positive in 37.5% of the patients in the first group, 35% of the patients in the second group, 20% of the patients in the third group and 9.5% of the patients in the fourth group. Groups 1 and 2 and, groups 3 and 4 were compared to evaluate the effect of the splint. While forearm-based thumb splint affected the results positively in healthy individuals, it was determined that it had no effect on the results in diabetic patients. CONCLUSION: Although corticosteroid treatment is effective in the treatment of de Quervain's tenosynovitis in healthy and diabetic individuals, the results are worse in diabetic patients than in healthy patients. In addition, the use of splint with corticosteroid injection in healthy individuals positively affects the results, while it does not affect the results in diabetic patients.


Assuntos
Corticosteroides/farmacologia , Doença de De Quervain/tratamento farmacológico , Contenções/normas , Tenossinovite/tratamento farmacológico , Corticosteroides/uso terapêutico , Adulto , Idoso , Análise de Variância , Doença de De Quervain/complicações , Doença de De Quervain/fisiopatologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Método Simples-Cego , Contenções/estatística & dados numéricos , Estatísticas não Paramétricas , Tenossinovite/complicações , Tenossinovite/fisiopatologia
5.
Trials ; 22(1): 604, 2021 Sep 08.
Artigo em Inglês | MEDLINE | ID: mdl-34496938

RESUMO

BACKGROUND: The sequence of establishing a proximal stability or function before facilitation of the distal body part has long been recognized in stroke rehabilitation practice but lacks scientific evidence. This study plans to examine the effects of proximal priority robotic priming and impairment-oriented training (PRI) and distal priority robotic priming and impairment-oriented training (DRI). METHODS: This single-blind, randomized, comparative efficacy study will involve 40 participants with chronic stroke. Participants will be randomized into the PRI or DRI groups and receive 18 intervention sessions (90 min/day, 3 days/weeks for 6 weeks). The Fugl-Meyer Assessment Upper Extremity subscale, Medical Research Council Scale, Revised Nottingham Sensory Assessment, and Wolf Motor Function Test will be administered at baseline, after treatment, and at the 3-month follow-up. Two-way repeated-measures analysis of variance and the chi-square automatic interaction detector method will be used to examine the comparative efficacy and predictors of outcome, respectively, after PRI and DRI. DISCUSSION: Through manipulating the sequence of applying wrist and forearm robots in therapy, this study will attempt to examine empirically the priming effect of proximal or distal priority robotic therapy in upper extremity impairment-oriented training for people with stroke. The findings will provide directions for further studies and empirical implications for clinical practice in upper extremity rehabilitation after stroke. TRIAL REGISTRATION: ClinicalTrials.gov NCT04446273. Registered on June 23, 2020.


Assuntos
Procedimentos Cirúrgicos Robóticos , Robótica , Acidente Vascular Cerebral , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Método Simples-Cego , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/terapia , Extremidade Superior
6.
BMJ Open ; 11(8): e052598, 2021 08 27.
Artigo em Inglês | MEDLINE | ID: mdl-34452970

RESUMO

OBJECTIVES: To evaluate whether a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty offers superior outcomes to traditional outpatient physiotherapy. DESIGN: A prospective, single-blind, two-arm randomised controlled superiority trial. SETTING: 14 National Health Service physiotherapy departments in the UK. PARTICIPANTS: 621 participants identified at high risk of a poor outcome after knee arthroplasty using a bespoke screening tool. INTERVENTIONS: A multicomponent home-based rehabilitation programme delivered by rehabilitation assistants with supervision from qualified therapists versus usual care outpatient physiotherapy. MAIN OUTCOME MEASURES: The primary outcome was the Late-Life Function and Disability Instrument (LLFDI) at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function), Knee injury and Osteoarthritis Outcome Score Quality of Life subscale, Physical Activity Scale for the Elderly, 5 dimension, 5 level version of Euroqol (EQ-5D-5L) and physical function assessed using the Figure of 8 Walk test, 30 s Chair Stand Test and Single Leg Stance. RESULTS: 621 participants were randomised between March 2015 and January 2018. 309 were assigned to CORKA (Community Rehabilitation after Knee Arthroplasty) home-based rehabilitation, receiving a median five treatment sessions (IQR 4-7). 312 were assigned to usual care, receiving a median 4 sessions (IQR 2-6). The primary outcome, LLFDI function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference=0.49 points; 95% CI -0.89 to 1.88; p=0.48). There were no statistically significant differences between the groups on any of the patient-reported or physical secondary outcome measures at 6 or 12 months.There were 18 participants in the intervention group reporting a serious adverse event (5.8%), only one directly related to the intervention, all other adverse events recorded throughout the trial related to underlying chronic medical conditions. CONCLUSIONS: The CORKA intervention was not superior to usual care. The trial detected no significant differences, clinical or statistical, between the two groups on either primary or secondary outcomes. CORKA offers an evaluation of an intervention utilising a different service delivery model for this patient group. TRIAL REGISTRATION NUMBER: ISRCTN13517704.


Assuntos
Artroplastia do Joelho , Idoso , Análise Custo-Benefício , Humanos , Modalidades de Fisioterapia , Estudos Prospectivos , Qualidade de Vida , Método Simples-Cego , Medicina Estatal
7.
Trials ; 22(1): 535, 2021 Aug 13.
Artigo em Inglês | MEDLINE | ID: mdl-34389022

RESUMO

BACKGROUND: Anxiety is frequently observed in the preoperative setting. The negative impact of preoperative anxiety is well known. In the context of gynaecological surgery, anxiety is exacerbated by the fact that the intervention can have catastrophic repercussions on a woman's body image, sexuality, and psycho-affective well-being. Music listening is increasingly used as an alternative therapy for minimizing preoperative anxiety. Personal preferences, familiarity, and popularity may be key elements for an optimal relaxation response to music. This study aimed to determine whether listening to self-selected music decreases preoperative anxiety in women scheduled to undergo gynaecologic surgery compared with predetermined music from an application (MUSIC CARE®). METHODS: The MUANX study was a single-blind, monocentric, parallel, superiority, randomized controlled trial. A total of 174 women were included and randomized in two groups between August 2017 and September 2018. Patients in the intervention group listened to the personal music playlist that they had created before being hospitalized. Patients in the control group listened to the predetermined playlist on the MUSIC CARE® application. All patients received standard nursing care and listened to 20 min of music 1 h before surgery. Anxiety scores were assessed before and after the music session using Spielberger's State-Trait Anxiety Inventory (STAI). RESULTS: The mean age of the 171 evaluated patients was 41.5 years (SD = 10.0 years). Before the music session, the STAI state anxiety score was similar in the control group (M = 38.8, SD = 11.9) and the intervention group (M = 39.0, SD = 13.1). After the music session, this score had significantly decreased in both the control group (M = -7.2, SD = 9.0) and the intervention group (M = -5.5, SD = 6.6), with no significant difference in score reduction between groups. Physiological parameters were unchanged after the music session. No significant differences in postoperative measurements (pain intensity, hospitalization duration) were observed between the two groups. CONCLUSION: Self-selected music is as effective as predetermined music for reducing patient anxiety before gynaecological surgery. As it has no side effects and is easily applicable in gynaecological surgical services, this non-drug intervention may be proposed by healthcare professionals in the management of preoperative anxiety. TRIAL REGISTRATION: The MUANX trial (MUsic therapy on ANXiety) is registered at the US National Institutes of Health ( ClinicalTrials.gov ) #NCT03226834. Registered on 24 July 2017. https://clinicaltrials.gov/ct2/show/NCT03226834?term=muanx&draw=2&rank=1.


Assuntos
Musicoterapia , Música , Adulto , Ansiedade/diagnóstico , Ansiedade/prevenção & controle , Feminino , Procedimentos Cirúrgicos em Ginecologia/efeitos adversos , Humanos , Método Simples-Cego
8.
Iran J Allergy Asthma Immunol ; 20(4): 494-499, 2021 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-34418903

RESUMO

No effective antiviral drugs and vaccines are available for the treatment of patients with severe coronavirus 2019 (COVID-19). Therefore, available, safe, and inexpensive drugs and supplements such as melatonin are among the proposed options for controlling inflammation. We did a randomized, single-blind study in Imam Khomeini Hospital between June 30, 2020, and August 5, 2020. Mild to moderate COVID-19 patients aged 25-65 years were eligible to enter the study based on chest CT scan, clinical symptoms, and physician diagnosis. The intervention group was prescribed 6 mg of oral melatonin for 2 weeks, which consumed half an hour before bedtime every night in low light conditions. Clinical symptoms and C-reactive protein (CRP) were measured before and after treatment in the melatonin received and control (regular medications) groups. Among screened patients with COVID-19, 14 patients were assigned to receive melatonin, and 17 patients were considered as controls. A significant difference (p=0.005) between CRP 1 and CRP 2 levels (before and after using melatonin) was found in the melatonin group while this difference (p=0.069) was not significant in the control group. Also, the percentage of recovery (based on symptoms) in patients who took melatonin was higher than that of patients in the control group (85.7% VS 47.1%). The result of this study confirmed the effectiveness of melatonin in mild to moderate outpatients with COVID-19. More clinical trials on elderly, diabetic, obese patients and severe cases are suggested in future studies.


Assuntos
COVID-19/tratamento farmacológico , Suplementos Nutricionais , Melatonina/uso terapêutico , Adulto , Proteína C-Reativa/análise , COVID-19/diagnóstico , Feminino , Humanos , Inflamação , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Distribuição Aleatória , SARS-CoV-2 , Método Simples-Cego , Resultado do Tratamento
9.
Medicine (Baltimore) ; 100(33): e26924, 2021 Aug 20.
Artigo em Inglês | MEDLINE | ID: mdl-34414949

RESUMO

INTRODUCTION: The occurrence of post-stroke emotional problems is significant during the early post-stroke stage and affects the recovery of functionality among the survivors. Because stroke survivors require active engagement in rehabilitation to optimize the process of neuroplasticity in the initial stage of stroke, there is a need to integrate an intervention, preferably therapists-mediated during rehabilitation, which reduce emotional problems thus improve motivation level among the survivors. One such technique is autogenic relaxation training (ART). ART has been found to reduce anxiety and depression among patients with several medical conditions. However, its usage in stroke survivors during rehabilitation has been limited to date. Therefore, this study is intended to evaluate the effectiveness of ART in addition to usual physiotherapy in improving emotional state and functional level of stroke survivors during rehabilitation. METHODS: This is an assessor blinded randomized controlled trial comparing 2 intervention approaches namely ART-added physiotherapy (experimental group) and usual physiotherapy (control group). A total of 70 post-stroke patients will be recruited and allocated into either the ART-added physiotherapy or the usual physiotherapy group. The ART-added physiotherapy group will undergo a 20-minute ART session followed by 40 minutes of usual physiotherapy. While the usual physiotherapy group will receive usual physiotherapy alone for 60 minutes. All participants will be treated once a week and are required to carry out a set of home exercises for 2 times per week during the 12-week intervention. Assessment of emotional status and functional independence will be carried out at pre-intervention and week 13 of the intervention with the use of Hospital anxiety and depression scale, Barthel index, and EuroQol-5 dimensions-5 levels. All data will be analyzed using descriptive and inferential statistics. DISCUSSION: The expected main study outcome is an enhanced evidence-based physiotherapy program that may be used by physiotherapists in the rehabilitation of stroke patients with emotional disturbances. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12619001664134 (last updated on 28/11/2019).


Assuntos
Treinamento Autógeno , Emoções , Estado Funcional , Modalidades de Fisioterapia/psicologia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Reabilitação do Acidente Vascular Cerebral/métodos , Reabilitação do Acidente Vascular Cerebral/psicologia , Humanos , Método Simples-Cego
10.
Oper Dent ; 46(2): 143-150, 2021 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-34464978

RESUMO

OBJECTIVE: This single-blind, split-mouth, randomized trial was aimed at evaluating the bleaching efficacy (BE) and tooth sensitivity (TS) of a 20% hydrogen peroxide (HP) bleaching agent used under active or passive application. METHODS AND MATERIALS: Twenty-two patients with canines darker than C2 were selected. Teeth were bleached in two sessions, with a one-week interval between treatments. The bleaching agent was applied using active (HPactive) or passive (HPpassive) application. Each tooth in the HPactive-allocated hemiarch received bleaching gel with sonic activation after 10 and 30 minutes from the start of treatment, with rounded movements all over the buccal surface. The color changes were evaluated by subjective (Vita Classical and Vita Bleachedguide) and objective (VITA Easyshade Spectrophotometer) methods at baseline and 30 days after the second session. TS was recorded up to 48 hours after treatment using a 0-10 visual analog scale. Color change in shade guide units (SGUs) and ΔE was analyzed using a Wilcoxon test (α=0.05). The absolute risk and intensity of TS were evaluated using McNemar test and a Wilcoxon test, respectively (α=0.05). RESULTS: Significant whitening was observed in both groups after 30 days of clinical evaluation. The activation did not significantly influence BE (ΔSGU HPpassive=5.6 and HPActive=5.8; p=0.98; and ΔE HPpassive=10.6 and HPactive=10.3; p=0.83). Absolute risk of TS (HPactive=36.4% and HPpassive=31.8%; p=0.94) was similar for both groups (Fisher exact test). TS intensity (visual analogue scale) was higher during the bleaching sessions and up to 24 hours thereafter for both groups, with no differences between groups (two-way analysis of variance and Tukey). CONCLUSION: The active application of a 20% HP gel did not improve BE and TS.


Assuntos
Sensibilidade da Dentina , Clareadores Dentários , Clareamento Dental , Sensibilidade da Dentina/induzido quimicamente , Humanos , Peróxido de Hidrogênio , Método Simples-Cego , Clareadores Dentários/uso terapêutico , Resultado do Tratamento
11.
BMC Med Educ ; 21(1): 436, 2021 Aug 18.
Artigo em Inglês | MEDLINE | ID: mdl-34407810

RESUMO

BACKGROUND: The educational efficacy in neonatal resuscitation relies on the subject and teaching strategies. Therefore, it is imperative to test diverse educational methods if they are more instructive to engage students in active learning and practicing knowledge. Hence, the present study aims to investigate the efficacy of a pedagogical framework in neonatal resuscitation skill learning among nursing students in a resource-limited setting. METHODS: A single-blind randomized controlled trial was conducted between October 2020 to March 2021. Sixty nursing students in the 3rd and 4th year of professional training were randomly allocated to the pedagogy and the traditional group. The pedagogy group learned via 6-step LSPPDM (Learn, See, Practice, Prove, Do, Maintain) pedagogy including lectures, video, clinical observation, skill sessions under supervision, and self-directed practice. The traditional group learned through 2-step (Learn, Practice) method that included lectures and skill sessions under supervision. The outcomes measured included technical and non-technical skills in neonatal resuscitation. The technical skill deals with steps such as stimulation, ventilation, oxygenation, intubation, chest compression, medications, and reporting. Non-technical skills refer to teamwork skills that focus on the interaction between leader and helper. Both skills were measured through previously published validated tools two times before and after the intervention by blinded assessors in a simulated delivery room. RESULTS: Overall, the skill was significantly improved in both groups after intervention. Yet, the results showed that the mean difference of technical skill score in the pedagogy group (24.3 ± 3.5) was significantly higher (p <  0.001) compared to the traditional group (16.2 ± 2.4). Likewise, the mean difference of non-technical skill score in the pedagogy (36.9 ± 1.9) was highly significant (p <  0.001) compared to the traditional group (31.2 ± 1.7). CONCLUSIONS: The LSPPDM pedagogy was found more effective in enhancing technical and non-technical skills in neonatal resuscitation compared to the traditional method. The results of this study support the efficacy of the 6-step LSPPDM pedagogy in the education of nursing students regarding neonatal resuscitation in a resource-limited setting. TRIAL REGISTRATION: Prospectively registered at ClinicalTrials.gov ( NCT04748341 ).


Assuntos
Ressuscitação , Estudantes de Enfermagem , Competência Clínica , Humanos , Recém-Nascido , Aprendizagem , Método Simples-Cego
12.
BMJ Open ; 11(8): e043883, 2021 08 10.
Artigo em Inglês | MEDLINE | ID: mdl-34376438

RESUMO

OBJECTIVE: The transmuscular quadratus lumborum (TQL) block and the oblique subcostal transversus abdominis plane (OSTAP) block both contribute to multimodal analgesia after laparoscopic surgery. The objective of this study was to compare the analgesic effects of the TQL block versus OSTAP block after laparoscopic hysterectomy. DESIGN: Prospective single-centre randomised single-blind trial. SETTING: University-affiliated hospital. PARTICIPANTS: Patients aged between 18 and 65 years scheduled for laparoscopic hysterectomy. INTERVENTIONS: Patients were randomised into two groups (1:1 ratio) and received bilateral TQL block or bilateral OSTAP block with 0.375% ropivacaine 20 mL on each side before surgery. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome measure was the cumulative morphine dose in the first 24 hours. The secondary outcome measures were the morphine consumption at each time interval after surgery, the time from the end of surgery to the first need for morphine, the Numerical Rating Scale (NRS) scores for visceral and incisional pain intensity, and the incidence of adverse events. RESULTS: The cumulative morphine dose was significantly lower in the TQL group than in the OSTAP group (17.2 (12.5) vs 26.1 (13.3) mg, p=0.010). Compared with the OSTAP group, the morphine doses from 6 to 12, 12 to 18, and 18 to 24 hours were significantly lower, the time of first need for morphine was significantly longer and the NRS scores for visceral pain intensity were significantly lower in the TQL group. CONCLUSION: Compared with the OSTAP block, the TQL block reduced morphine consumption and provided better visceral pain relief with a longer duration of effect after laparoscopic hysterectomy. TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registry (ChiCTR1800017995); pre-results.


Assuntos
Analgesia , Laparoscopia , Músculos Abdominais , Adolescente , Adulto , Idoso , Analgésicos Opioides , Anestésicos Locais , Método Duplo-Cego , Feminino , Humanos , Histerectomia , Pessoa de Meia-Idade , Dor Pós-Operatória/tratamento farmacológico , Dor Pós-Operatória/prevenção & controle , Estudos Prospectivos , Método Simples-Cego , Adulto Jovem
13.
Medicina (Kaunas) ; 57(8)2021 Jul 21.
Artigo em Inglês | MEDLINE | ID: mdl-34440942

RESUMO

Background and Objectives: The motor sequelae after a stroke are frequently persistent and cause a high degree of disability. Cortical ischemic or hemorrhagic strokes affecting the cortico-spinal pathways are known to cause a reduction of cortical excitability in the lesioned area not only for the local connectivity impairment but also due to a contralateral hemisphere inhibitory action. Non-invasive brain stimulation using high frequency repetitive magnetic transcranial stimulation (rTMS) over the lesioned hemisphere and contralateral cortical inhibition using low-frequency rTMS have been shown to increase the excitability of the lesioned hemisphere. Mental representation techniques, neurofeedback, and virtual reality have also been shown to increase cortical excitability and complement conventional rehabilitation. Materials and Methods: We aim to carry out a single-blind, randomized, controlled trial aiming to study the efficacy of immersive multimodal Brain-Computer Interfacing-Virtual Reality (BCI-VR) training after bilateral neuromodulation with rTMS on upper limb motor recovery after subacute stroke (>3 months) compared to neuromodulation combined with conventional motor imagery tasks. This study will include 42 subjects in a randomized controlled trial design. The main expected outcomes are changes in the Motricity Index of the Arm (MI), dynamometry of the upper limb, score according to Fugl-Meyer for upper limb (FMA-UE), and changes in the Stroke Impact Scale (SIS). The evaluation will be carried out before the intervention, after each intervention and 15 days after the last session. Conclusions: This trial will show the additive value of VR immersive motor imagery as an adjuvant therapy combined with a known effective neuromodulation approach opening new perspectives for clinical rehabilitation protocols.


Assuntos
Interfaces Cérebro-Computador , Reabilitação do Acidente Vascular Cerebral , Acidente Vascular Cerebral , Realidade Virtual , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Recuperação de Função Fisiológica , Método Simples-Cego , Acidente Vascular Cerebral/terapia , Resultado do Tratamento , Extremidade Superior
14.
Quintessence Int ; 52(9): 820-826, 2021 Sep 09.
Artigo em Inglês | MEDLINE | ID: mdl-34369941

RESUMO

OBJECTIVES: This study was designed as a prospective randomized single-blind clinical trial to compare the anesthetic efficacy of inferior alveolar nerve block (IANB), IANB plus buccal infiltration, and IANB plus lingual infiltration of 4% articaine with 1:100,000 epinephrine in mandibular molars with irreversible pulpitis. METHOD AND MATERIALS: Sixty healthy volunteers who had a first or second mandibular molar diagnosed with irreversible pulpitis participated in the present study. This study was composed of three arms for the first molar and three arms for the second molar. Subjects in test arm A received two IANB injections (3.6 mL). Subjects in test arm B received 1.8 mL IANB injection plus 1.8 mL buccal infiltration. Subjects in test arm C received 1.8 mL IANB injection plus 1.8 mL lingual infiltration. Articaine (4%) with 1:100,000 epinephrine was used for all injections. The subject's pain during access preparation and pulp extirpation was recorded on the Heft-Parker visual analog scale. Success was defined as "none" or "mild" pain during treatment. Kruskal-Wallis test was used to compare pain categories in three groups of interventions for each mandibular molar. RESULTS: IANB with a supplemented buccal infiltration provided more success than IANB alone or IANB plus lingual infiltration, in first molars (P = .019). There were no significant differences between the three injection techniques in second molars (P = .795). CONCLUSIONS: Adding a supplemental buccal infiltration to a standard IANB was more successful in providing pain-free treatment for patients experiencing irreversible pulpitis in mandibular first molars.


Assuntos
Anestesia Dentária , Bloqueio Nervoso , Pulpite , Anestésicos Locais , Carticaína , Método Duplo-Cego , Humanos , Lidocaína , Nervo Mandibular , Dente Molar , Estudos Prospectivos , Pulpite/cirurgia , Método Simples-Cego
15.
Expert Opin Drug Metab Toxicol ; 17(9): 1149-1156, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34372746

RESUMO

PURPOSE: To compare the pharmacokinetics, pharmacodynamics and safety of the new prolonged-release leuprorelin acetate microspheres for injection (3.75 mg) with the reference product Enantone® (3.75 mg). METHOD: 48 healthy male volunteers were enrolled and randomly received a single 3.75 mg dose of the test drug or Enantone®. RESULTS: There were no significant differences in Cmax, AUC0-t and AUC0-48 between the test group and reference group (P > 0.05). The 90% confidence intervals of the two groups were 87.49%~112.74%, 97.15%~154.25%, and 80.85%~109.01%, respectively. Twenty-eight days after administration, both groups reached 100.0% castration level; there was no difference in the time from administration to reaching castration level between the two groups (P > 0.05); However, the difference between the two groups in the duration of castration level was statistically significant (P < 0.05). There were no major or serious adverse events, and the severity was mild to moderate. CONCLUSION: The pharmacokinetic characteristics of leuprorelin in two groups were consistent. The two groups exhibited similar inhibitory effects on testosterone and more subjects in the test group maintained a longer castration time than those in the reference group.


Assuntos
Antineoplásicos Hormonais/administração & dosagem , Leuprolida/administração & dosagem , Testosterona/sangue , Adulto , Antineoplásicos Hormonais/farmacocinética , Antineoplásicos Hormonais/farmacologia , Área Sob a Curva , Preparações de Ação Retardada , Humanos , Injeções , Leuprolida/farmacocinética , Leuprolida/farmacologia , Masculino , Microesferas , Método Simples-Cego , Fatores de Tempo , Adulto Jovem
16.
BMC Psychiatry ; 21(1): 418, 2021 08 21.
Artigo em Inglês | MEDLINE | ID: mdl-34419010

RESUMO

BACKGROUND: Depression and chronic diseases are frequently comorbid public health problems. However, clinical guidelines often fail to consider comorbidities. This study protocol describes a cluster randomized trial (CRT) aimed to compare the effectiveness of a collaborative, computer-assisted, psycho-educational intervention versus enhanced usual care (EUC) in the treatment of depressed patients with hypertension and/or diabetes in primary care clinics (PCC) in Santiago, Chile. METHODS: Two-arm, single-blind, CRT carried out at two municipalities in Santiago, Chile. Eight PCC will be randomly assigned (1:1 ratio within each municipality, 4 PCC in each municipality) to the INTERVENTION or EUC. A total of 360 depressed patients, aged at least 18 years, with Patient Health Questionnaire-9 Item [PHQ-9] scores ≥15, and enrolled in the Cardiovascular Health Program at the participating PCC. Patients with alcohol/substance abuse; current treatment for depression, bipolar disorder, or psychosis; illiteracy; severe impairment; and resident in long-term care facilities, will be excluded. Patients in both arms will be invited to use the Web page of the project, which includes basic health education information. Patients in the INTERVENTION will receive eight sessions of a computer-assisted, psycho-educational intervention delivered by trained therapists, a structured telephone calls to monitor progress, and usual medical care for chronic diseases. Therapists will receive biweekly and monthly supervision by psychologist and psychiatrist, respectively. A monthly meeting will be held between the PCC team and a member of the research team to ensure continuity of care. Patients in EUC will receive depression treatment according to clinical guidelines and usual medical care for chronic diseases. Outcome assessments will be conducted at 3, 6, and 12 months after enrollment. The primary outcome will be depression improvement at 6 months, defined as ≥50% reduction in baseline PHQ-9 scores. Intention-to-treat analyses will be performed. DISCUSSION: This study will be one of the first to provide evidence for the effectiveness of a collaborative, computer-assisted, psycho-educational intervention for depressed patients with chronic disease at primary care in a Latin American country. TRIAL REGISTRATION: retrospectively registered in ClinicalTrials.gov , first posted: November 3, 2020, under identifier: NCT04613076 .


Assuntos
Depressão , Atenção Primária à Saúde , Adolescente , Adulto , Doença Crônica , Computadores , Depressão/terapia , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Método Simples-Cego
17.
Trials ; 22(1): 579, 2021 Aug 30.
Artigo em Inglês | MEDLINE | ID: mdl-34461975

RESUMO

BACKGROUND: Most cancer survivors are married, and cancer strains the physical and mental health of each partner and their intimate relationship. We created a partnered strength training program, Exercising Together©, where the survivor and his/her partner exercise as a team in order to improve physical and mental health of both members of the couple as well as the quality of their relationship. We have not yet determined if Exercising Together© is similarly effective in couples coping with different types of cancer nor if training as a team has unique and added benefits over those derived from supervised group training and/or shared behavior change. The purpose of this study is to determine the unique benefits of Exercising Together© on physical, mental, and relational health in couples coping with breast, prostate, or colorectal cancer. METHODS: Survivors of prostate, breast and colorectal cancer (N = 294, 98 per cancer site) and their intimate, co-residing partners are recruited to participate in a single-blind, parallel group, randomized trial comparing three exercise groups that train twice per week for 6 months. Couples are randomized to one of three groups: (1) Exercising Together© where partners train as a team in a supervised group setting; (2) separate supervised group exercise classes for survivors or partners, respectively; (3) unsupervised home exercise program provided to each partner. The primary outcome is relationship quality (dyadic coping by the Dyadic Coping scale, emotional intimacy by the Dyadic Adjustment Scale, physical intimacy by the Physical Intimacy Behavior Scale, and symptom incongruence). Secondary outcomes are physical health (% body fat by DXA, serum fasting lipids (triglycerides, HDL, and LDL cholesterol), insulin resistance (HOMA-IR), resting blood pressure, C-reactive protein, TNF alpha, and physical functioning by the short Physical Performance Battery and SF-36) and mental health (depressive symptoms, anxiety, fear of recurrence) of each partner. Outcomes are collected at baseline, mid (3 months), post-intervention (6 months), and follow-up (12 months). DISCUSSION: Exercising Together© could shift the paradigm of survivorship care toward novel couple-based approaches that could optimize outcomes for each partner because their health is interdependent on each other and their relationship. TRIAL REGISTRATION: ClinicalTrials.gov NCT03630354 . Registered August 14, 2018.


Assuntos
Recidiva Local de Neoplasia , Qualidade de Vida , Adaptação Psicológica , Exercício Físico , Feminino , Humanos , Masculino , Ensaios Clínicos Controlados Aleatórios como Assunto , Método Simples-Cego
18.
Artigo em Inglês | MEDLINE | ID: mdl-34444003

RESUMO

This study evaluated the effectiveness of a microcurrent toothbrush (approved by the US Food and Drug Administration [FDA]), which employs a superimposed alternating and direct electric current, named as a Proxywave® technology, similar to the intensity of the biocurrent, in plaque removal and reducing gingivitis by biofilm removal through the bioelectric effect. This study enrolled 40 volunteers with gingivitis. Dental observations were made every two weeks, before and after the use of each toothbrush. We randomly assigned participants into two groups: one group used the Proxywave® toothbrush (PB) for two weeks followed by the control toothbrush (CB) for two weeks, while the other group used the CB for two weeks followed by the PB. The participants had a two-week washout period. If the toothbrush used earlier has had an effect on the bacterial flora in the oral cavity, this is to remove this effect and return it to its previous state. During each dental visit, we recorded plaque index (PI) and gingival index (GI) scores. The PI and GI scores were significantly lower in both the PB and the CB (p < 0.05). Considering the PI, there was no significant difference between the toothbrushes on all the surfaces. Considering the GI, the PB showed a significant decrease in the interproximal surface, compared to the CB (p < 0.05). The PB showed a significant decrease in the interproximal GI and had a beneficial effect in the interproximal area where the bristles could not reach. No adverse events were observed in the participants during the clinical trial. The microcurrent toothbrush is a device that can be safely used for plaque removal.


Assuntos
Gengivite , Escovação Dentária , Desenho de Equipamento , Gengivite/prevenção & controle , Humanos , Índice Periodontal , Método Simples-Cego
19.
Medicine (Baltimore) ; 100(31): e26691, 2021 Aug 06.
Artigo em Inglês | MEDLINE | ID: mdl-34397802

RESUMO

BACKGROUND: Ventriculoperitoneal shunt (VPS) and lumboperitoneal shunt (LPS) remain the mainstay of idiopathic normal pressure hydrocephalus (INPH). There are no randomized controlled trials completed to compare the efficacy of these 2 shunt techniques. METHODS/DESIGN: We will conduct a monocentric, assessor-blinded, and randomized controlled trial titled "Comparison of Ventriculoperitoneal Shunt to Lumboperitoneal Shunt for the treatment of Idiopathic Normal Pressure Hydrocephalus: Phase I (COVLINPH-1)" trial and recruit patients at West China Hospital of Sichuan University since June 2021. And this trial is expected to end in December 2030. Eligible participants will be randomly assigned into LPS group and VPS group at ratio of 1:1 followed by evaluation before surgery, 1 month, 12 months, and 5 years after surgery. The primary outcome is the rate of shunt failure within 5 years. The secondary outcomes include modified Rankin Scale (mRS), INPH grading scale (INPHGS), mini-mental state examination (MMSE), and Evans index. We will calculate the rate of favorable outcome, which is defined as shunt success and an improvement of more than 1 point in the mRS at evaluation point. We will also analyze the complications throughout the study within 5 years after shunt insertion. DISCUSSION: The results of this trial will provide state-of-the-art evidence on the treatment option for patients with INPH, and will also generate the discussion regarding this subject. TRIAL REGISTRATION NUMBER: ChiCTR2000031555; Pre-results.


Assuntos
Hidrocefalia de Pressão Normal/cirurgia , Peritônio/cirurgia , Espaço Subaracnóideo/cirurgia , Derivação Ventriculoperitoneal , Drenagem/efeitos adversos , Drenagem/métodos , Humanos , Vértebras Lombares , Ensaios Clínicos Controlados Aleatórios como Assunto , Método Simples-Cego , Derivação Ventriculoperitoneal/efeitos adversos
20.
Nutrients ; 13(7)2021 Jul 02.
Artigo em Inglês | MEDLINE | ID: mdl-34371806

RESUMO

BACKGROUND AND AIM: Sarcopenia is considered an important risk factor for morbidity and mortality in liver cirrhosis. Beta-hydroxy-beta-methylbutyrate (HMB) has the potential to increase muscle mass and performance by stimulating protein synthesis and reducing muscle catabolism. The present study aimed at evaluating the effect of HMB supplementation on muscle mass and function in patients with liver cirrhosis. Changes in frailty during the study were also estimated, and the safety of HMB supplementation was verified. METHODS: This is a randomized, single-blind, placebo-controlled pilot trial. Twenty-four patients (14 HMB and 10 placebo) affected by liver cirrhosis were enrolled in the study. Each patient received dedicated counseling, which included nutrition and physical activity recommendations for chronic liver disease patients. Patients were randomized to receive 3 g/day of HMB or placebo (sorbitol powder) for 12 consecutive weeks. A diet interview, anthropometry, electrical bioimpedance analysis (BIA), quadriceps ultrasound, physical performance battery, Liver Frailty Index (LFI), and cognitive tests were completed at enrolment (T0), at 12 weeks (T1), and 24 weeks after enrolment (T2). RESULTS: At baseline, the two groups were similar in demography, severity of liver disease, muscle mass, muscle function, and cognitive tests. LFI at baseline was higher in patients in the HMB group vs. those in the placebo group (4.1 ± 0.4 vs. 3.4 ± 0.6, p < 0.01). After treatment, a statistically significant increase in muscle function was seen in the HMB group (chair stand test: 14.2 ± 5 s vs. 11.7 ± 2.6 s, p < 0.05; six-minute walk test: 361.8 ± 68 m vs. 409.4 ± 58 m, p < 0.05). Quadriceps muscle mass measured by ultrasound also increased (4.9 ± 1.8 vs. 5.4 ± 1.8 mm, p < 0.05) after HMB, while LFI decreased (4.1 ± 0.4 vs. 3.7 ± 0.4, p < 0.05). HMB was well tolerated by patients, and no adverse events were documented. CONCLUSIONS: Our study suggests the efficacy of 12-week beta-hydroxy-beta-methylbutyrate supplementation in promoting improvements in muscle performance in compensated cirrhotic patients. LFI was also ameliorated. Further studies with a greater number of patients are required to reinforce this hypothesis.


Assuntos
Suplementos Nutricionais , Cirrose Hepática/terapia , Força Muscular/efeitos dos fármacos , Sarcopenia/prevenção & controle , Valeratos/administração & dosagem , Antropometria , Impedância Elétrica , Exercício Físico/fisiologia , Feminino , Fragilidade/etiologia , Fragilidade/prevenção & controle , Humanos , Cirrose Hepática/complicações , Cirrose Hepática/fisiopatologia , Masculino , Pessoa de Meia-Idade , Músculo Esquelético/efeitos dos fármacos , Projetos Piloto , Sarcopenia/etiologia , Método Simples-Cego , Resultado do Tratamento
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