16 research outputs found
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A multicentre, randomised controlled trial to compare the clinical and cost-effectiveness of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy versus control in Parkinson’s disease: a study protocol for a randomised controlled trial
Abstract: Background: Parkinson’s disease (PD) affects approximately 145,519 people in the UK. Speech impairments are common with a reported prevalence of 68%, which increase physical and mental demands during conversation, reliance on family and/or carers, and the likelihood of social withdrawal reducing quality of life. In the UK, two approaches to Speech and Language Therapy (SLT) intervention are commonly available: National Health Service (NHS) SLT or Lee Silverman Voice Treatment (LSVT LOUD®). NHS SLT is tailored to the individuals’ needs per local practice typically consisting of six to eight weekly sessions; LSVT LOUD® comprises 16 sessions of individual treatment with home-based practice over 4 weeks. The evidence-base for their effectiveness is inconclusive. Methods/design: PD COMM is a phase III, multicentre, three-arm, unblinded, randomised controlled trial. Five hundred and forty-six people with idiopathic PD, reporting speech or voice problems will be enrolled. We will exclude those with a diagnosis of dementia, laryngeal pathology or those who have received SLT for speech problems in the previous 2 years. Following informed consent and completion of baseline assessments, participants will be randomised in a 1:1:1 ratio to no-intervention control, NHS SLT or LSVT LOUD® via a central computer-generated programme, using a minimisation procedure with a random element, to ensure allocation concealment. Participants randomised to the intervention groups will start treatment within 4 (NHS SLT) or 7 (LSVT LOUD®) weeks of randomisation. Primary outcome: Voice Handicap Index (VHI) total score at 3 months. Secondary outcomes include: VHI subscales, Parkinson’s Disease Questionnaire-39; Questionnaire on Acquired Speech Disorders; EuroQol-5D-5 L; ICECAP-O; resource utilisation; adverse events and carer quality of life. Mixed-methods process and health economic evaluations will take place alongside the trial. Assessments will be completed before randomisation and at 3, 6 and 12 months after randomisation. The trial started in December 2015 and will run for 77 months. Recruitment will take place in approximately 42 sites around the UK. Discussion: The trial will test the hypothesis that SLT is effective for the treatment of speech or voice problems in people with PD compared to no SLT. It will further test whether NHS SLT or LSVT LOUD® provide greater benefit and determine the cost-effectiveness of both interventions. Trial registration: International Standard Randomised Controlled Trials Number (ISRCTN) Registry, ID: 12421382. Registered on 18 April 2016
Recommended from our members
A multicentre, randomised controlled trial to compare the clinical and cost-effectiveness of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy versus control in Parkinson’s disease: a study protocol for a randomised controlled trial
Abstract: Background: Parkinson’s disease (PD) affects approximately 145,519 people in the UK. Speech impairments are common with a reported prevalence of 68%, which increase physical and mental demands during conversation, reliance on family and/or carers, and the likelihood of social withdrawal reducing quality of life. In the UK, two approaches to Speech and Language Therapy (SLT) intervention are commonly available: National Health Service (NHS) SLT or Lee Silverman Voice Treatment (LSVT LOUD®). NHS SLT is tailored to the individuals’ needs per local practice typically consisting of six to eight weekly sessions; LSVT LOUD® comprises 16 sessions of individual treatment with home-based practice over 4 weeks. The evidence-base for their effectiveness is inconclusive. Methods/design: PD COMM is a phase III, multicentre, three-arm, unblinded, randomised controlled trial. Five hundred and forty-six people with idiopathic PD, reporting speech or voice problems will be enrolled. We will exclude those with a diagnosis of dementia, laryngeal pathology or those who have received SLT for speech problems in the previous 2 years. Following informed consent and completion of baseline assessments, participants will be randomised in a 1:1:1 ratio to no-intervention control, NHS SLT or LSVT LOUD® via a central computer-generated programme, using a minimisation procedure with a random element, to ensure allocation concealment. Participants randomised to the intervention groups will start treatment within 4 (NHS SLT) or 7 (LSVT LOUD®) weeks of randomisation. Primary outcome: Voice Handicap Index (VHI) total score at 3 months. Secondary outcomes include: VHI subscales, Parkinson’s Disease Questionnaire-39; Questionnaire on Acquired Speech Disorders; EuroQol-5D-5 L; ICECAP-O; resource utilisation; adverse events and carer quality of life. Mixed-methods process and health economic evaluations will take place alongside the trial. Assessments will be completed before randomisation and at 3, 6 and 12 months after randomisation. The trial started in December 2015 and will run for 77 months. Recruitment will take place in approximately 42 sites around the UK. Discussion: The trial will test the hypothesis that SLT is effective for the treatment of speech or voice problems in people with PD compared to no SLT. It will further test whether NHS SLT or LSVT LOUD® provide greater benefit and determine the cost-effectiveness of both interventions. Trial registration: International Standard Randomised Controlled Trials Number (ISRCTN) Registry, ID: 12421382. Registered on 18 April 2016
Modelo de predição de uma repetição máxima (1RM) baseado nas caracterÃsticas antropométricas de homens e mulheres Modelo de predicción de una repetición máxima (1RM) basado en las caracterÃsticas antropométricas de hombres y mujeres Prediction model of a maximal repetition (1RM) based on male and female anthropometrical characteristics
O objetivo do presente estudo foi desenvolver uma equação para predição da carga de uma repetição máxima (1RM) em homens e mulheres, usando exclusivamente as caracterÃsticas antropométricas. Participaram deste estudo 44 jovens de baixo risco, com experiência em treinamento de força, sendo 22 do sexo masculino (23 ± 4 anos, 76,6 ± 12,7kg, 173,9 ± 5,5cm, 11 ± 4,5% de gordura) e 22 do feminino (22 ± 4 anos, 54 ± 6,0kg, 161 ± 5,8cm, 18 ± 2,2% de gordura). Inicialmente, eles passaram por uma avaliação antropométrica seguida de um teste de 1RM de familiarização no exercÃcio de desenvolvimento, que foi repetido após 48h. A repetibilidade do teste de 1RM foi testada pelo Wilcoxon matched paired test. Finalmente, a carga de 1RM foi modelada em função das variáveis antropométricas por regressão linear múltipla (forward stepwise) usando como critério de corte das variáveis independentes deltar² < 0,01. A confiabilidade dos modelos foi expressa pela análise de Bland e Altman. Adotou-se em todos os testes alfa = 0,05. Não se registraram diferenças entre teste e reteste, resultando em 44,6 ± 13,2kg e 12,2 ± 3,2kg nos indivÃduos do sexo masculino (SM) e feminino (SF), respectivamente. Além das variáveis antropométricas, incluiu-se aos modelos o tempo de experiência em treinamento de força. No SM, o modelo resultou em 84% da variância explicada, com erro padrão equivalente a 12%. Por outro lado, no SF, a capacidade preditiva do modelo obtido foi mais fraca, resultando em 56% da variância explicada e erro padrão equivalente a 20%. Em conclusão, os modelos obtidos mostraram adequada confiabilidade, de forma que podem ser utilizados como ferramentas para predição da carga de 1RM.<br>El objetivo del presente estudio ha sido desarrollar una ecuación para predecir la carga de una repetición máxima (1RM) en hombres y mujeres, usando exclusivamente las caracterÃsticas antropométricas. Participaron de este estudio 44 jóvenes de bajo riesgo, con experiencia en entrenamiento de fuerza, 22 del sexo masculino (23 ± 4 años, 76,6 ± 12,7 kg, 173,9 ± 5,5 cm, 11 ± 4,5% de grasa) y 22 del sexo femenino (22 ± 4 años, 54 ± 6,0 kg, 161 ± 5,8 cm, 18 ± 2,2% de grasa). Al inicio, estos pasaron por una evaluación antropométrica seguida de un test de 1RM de familiarización en el ejercicio en desarrollo, que fue repetido después de 48 h. La repetibilidad del test de 1RM fue probada por Wilcoxon matched paired test. Finalmente la carga de 1RM fue modelada en función de las variables antropométricas por regresión lineal múltiple (forward stepwise) usando como criterio de aglomeración de las variables independientes deltar² < 0,01. La confiabilidad de los modelos se expresó por el análisis de Bland y Altman. En todos los tests se adoptó alfa = 0,05. No se registraron diferencias entre el test y el retest, resultando en 44,6 ± 13,2 kg y 12,2 ± 3,2kg en los individuos del sexo masculino (SM) y femenino (SF), respectivamente. Fuera de las variables antropométricas, se incluyó a los modelos el tiempo de experiencia en la actividad de fuerza. En el SM, el modelo resultó en 84% de la varianza explicada, con un error padrón equivalente a 12%. Por otro lado, en el SF, la capacidad predictiva del modelo obtenido no fue tan eficaz, resultando en 56% de la varianza explicada y un error padrón equivalente a 20%. En conclusión, los modelos obtenidos mostraron adecuada confiabilidad, de forma que pueden ser utilizados como herramientas para predecir la carga de 1RM.<br>The goal of the present study was to develop an equation for predicting the workload of one maximal repetition (1RM) in women and men, based exclusively on anthropometrical characteristics. Forty-four low-risk and experienced in strength training young subjects, being 22 male (23 ± 4 years, 76.6 ± 12.7 kg, 173.9 ± 5.5 cm, 11 ± 4.5 % of body fat) and 22 female (22 ± 4 years, 54 ± 6.0 kg, 161 ± 5.8 cm, 18 ± 2.2 % of body fat) volunteered for this study. All subjects were submitted to an anthropometrical evaluation followed by a 1RM familiarization test (shoulder press), which was repeated after 48h. The repeatability was tested using Wilcoxon Matched paired test. Finally, the 1RM workload was modeled in relation to the anthropometrical variables through multiple linear regression (forward stepwise) using as cutoff criteria for the independent variables deltar² < 0.01. The models reliability was expressed by the Bland and Altman analysis. All tests assumed alpha = 0.05. No significant differences were recorded between the two tests, resulting 44.6 ± 13.2 kg and 12.2 ± 3.2kg, for male (MS) and female (FS) subjects respectively. The time of practice in strength training was also included in the models. The model resulted in 84% of explained variance and a standard error of 12% for the MS. On the other hand, for the FS the predictive capacity was weaker than for = the MS, resulting in 56% of the explained variance and a standard error of 20%. In conclusion, the obtained models showed acceptable reliability so that they can be currently used as a tool for predicting the 1RM workload