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Randomised control trails

Sanne Steyaert, Els Holvoet, Evi Nagler, Simon Malfait, Wim Van Biesen
BACKGROUND: Clinical trials are most informative for evidence-based decision-making when they consistently measure and report outcomes of relevance to stakeholders, especially patients, clinicians, and policy makers. However, sometimes terminology used is interpreted differently by different stakeholders, which might lead to confusion during shared decision making. The construct dialysis adequacy is frequently used, suggesting it is an important outcome both for health care professionals as for patients...
2019: PloS One
Eleftheria Vaportzis, Malwina A Niechcial, Alan J Gow
Activities running in community-based-settings offer a method of delivering multimodal interventions to older adults beyond cognitive training programmes. This systematic review and meta-analysis investigated the impact of randomised controlled trials (RCTs) of 'real-world' interventions on the cognitive abilities of healthy older adults. Database searches were performed between October 2016 and September 2018. Forty-three RCTs were eligible for inclusion with 2,826 intervention participants and 2,234 controls...
January 29, 2019: Ageing Research Reviews
Jane Fossey, Lucy Garrod, Christina Tolbol Froiland, Clive Ballard, Vanessa Lawrence, Ingelin Testad
OBJECTIVES: To understand the factors that care home staff felt enabled or hindered them in continuing to use the WHELD psychosocial approach in their care home and investigate whether there was sustained activity nine - twelve months after the study ended. METHODS: This qualitative study is part of a wider clinical trial which demonstrated effectiveness of a psychosocial intervention on quality of life outcomes and neuropsychiatric symptoms for residents. 47 care home staff within nine care homes in the UK participated in focus groups, between nine and 12 months after the intervention had finished...
January 31, 2019: International Journal of Geriatric Psychiatry
Jerome Sarris, Gerard J Byrne, Lachlan Cribb, Georgina Oliver, Jenifer Murphy, Patricia Macdonald, Sonia Nazareth, Diana Karamacoska, Samantha Galea, Anika Short, Carolyn Ee, Yoann Birling, Ranjit Menon, Chee H Ng
Partial or non-response to antidepressants in Generalized Anxiety Disorder (GAD) is common in clinical settings, and adjunctive biological interventions may be required. Adjunctive herbal and nutraceutical treatments are a novel and promising treatment option. L-theanine is a non-protein amino acid derived most-commonly from tea (Camellia sinensis) leaves, which may be beneficial in the treatment of anxiety and sleep disturbance as suggested by preliminary evidence. We conducted a 10-week study (consisting of an 8-week double-blind placebo-controlled period, and 1-week pre-study and 2-week post-study single-blinded observational periods) involving 46 participants with a DSM-5 diagnosis of GAD...
December 8, 2018: Journal of Psychiatric Research
Narelle Eather, Nicholas Riley, Andrew Miller, Veronica Smith, Ashleigh Poole, Lisa Vincze, Philip J Morgan, David R Lubans
OBJECTIVES: The primary aim of this study was to evaluate the preliminary efficacy and feasibility of an 8-week high-intensity interval training program (Uni-HIIT) for young adult students in a university setting. DESIGN: Randomised controlled trial. METHOD: Uni-HIIT was conducted at the University of Newcastle, Australia (February-June, 2017). Participants were university students 18-25yrs (n=53; 20.38±1.88yrs) randomized into the Uni HIIT program (n=26) or wait-list control (n=27) condition...
November 24, 2018: Journal of Science and Medicine in Sport
Genevieve Z Steiner, Alan Bensoussan, Jianxun Liu, Mark I Hohenberg, Dennis H Chang
BACKGROUND: Mild cognitive impairment (MCI) is a syndrome characterised by a decline in cognition but relatively intact activities of daily living. People with MCI have an increased risk of developing dementia, and MCI is often referred to as a transitional stage between healthy ageing and dementia. Currently, there are no pharmaceutical therapies approved by the US Federal Drug Administration for MCI. Randomised controlled trials on the two major classes of anti-dementia pharmaceuticals, cholinesterase inhibitors and glutamate receptor antagonists, have produced poor results in MCI cohorts...
September 25, 2018: Trials
Ane Arbillaga-Etxarri, Elena Gimeno-Santos, Anael Barberan-Garcia, Eva Balcells, Marta Benet, Eulàlia Borrell, Nuria Celorrio, Anna Delgado, Carme Jané, Alicia Marin, Carlos Martín-Cantera, Mónica Monteagudo, Nuria Montellà, Laura Muñoz, Pilar Ortega, Diego A Rodríguez, Robert Rodríguez-Roisin, Pere Simonet, Pere Torán-Monserrat, Jaume Torrent-Pallicer, Pere Vall-Casas, Jordi Vilaró, Judith Garcia-Aymerich
There is a need to increase and maintain physical activity in patients with chronic obstructive pulmonary disease (COPD). We assessed 12-month efficacy and effectiveness of the Urban Training intervention on physical activity in COPD patients.This randomised controlled trial (NCT01897298) allocated 407 COPD patients from primary and hospital settings 1:1 to usual care (n=205) or Urban Training (n=202). Urban Training consisted of a baseline motivational interview, advice to walk on urban trails designed for COPD patients in outdoor public spaces and other optional components for feedback, motivation, information and support (pedometer, calendar, physical activity brochure, website, phone text messages, walking groups and a phone number)...
October 2018: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
Lisa K Stamp, Peter T Chapman, Murray Barclay, Anne Horne, Christopher Frampton, Paul Tan, Jill Drake, Nicola Dalbeth
Objectives: To determine factors that predict inadequate serum urate (SU) lowering response in a randomized controlled trial of allopurinol dose escalation (DE) in gout. Methods: Participants undergoing allopurinol DE were classified as: complete response (CR)-reached target SU at month 9 and 12 of the DE phase or if still dose escalating at month 9 reached target SU by month 12; partial response (PR)-reached target at some stage but not fulfilling criteria for CR; or inadequate response (IR)-did not reach target SU at any time...
December 1, 2018: Rheumatology
Yin-Wei Chen, Yong-Hua Niu, Dao-Qi Wang, Hao Li, Gaurab Pokhrel, Hao Xu, Tao Wang, Shao-Gang Wang, Ji-Hong Liu
Varicocele is one of the common correctable causes of male infertility. Recent studies have demonstrated varicocelectomy in males with abnormal semen parameters was associated with better fertility outcome, but the effect of adjuvant drug therapy after varicocelectomy on fertility outcome in patients with varicocele-associated infertility remains undefined. Hence, the present meta-analysis was performed to assess the efficacy of adjuvant drug therapy after varicocelectomy. The protocol was registered with PROSPERO (No...
July 11, 2018: Andrologia
Mark A Tully, Conor Cunningham, Margaret E Cupples, Duane Farrell, Wendy Hardeman, Ruth F Hunter, Bob Laventure, Suzanne M McDonough, Joanne Morgan, Marie H Murphy, Ellen E A Simpson, Catrine Tudor-Locke, Ashlene Wright, Frank Kee
Background: Levels of physical activity decline with age. Some of the most disadvantaged individuals in society, such as those from lower socio-economic position, are also the most inactive. Increasing physical activity levels, particularly among those most inactive, is a public health priority. Peer-led physical activity interventions may offer a model to increase physical activity in the older adult population. This study aims to test the feasibility of a peer-led, multicomponent physical activity intervention in socio-economically disadvantaged community dwelling older adults...
2018: Pilot and Feasibility Studies
Walid Bouaziz, Elise Schmitt, Thomas Vogel, François Lefebvre, Pierre-Marie Leprêtre, Georges Kaltenbach, Bernard Geny, Pierre-Olivier Lang
BACKGROUND: Interval aerobic training programme with active recovery bouts (IATP-R) has shown to improve tolerance to IATP among seniors. However, data concerning its benefits for seniors' health are still limited. PURPOSE: The purpose of this study was to examine the effects of IATP-R on seniors' health status. METHODS: Sedentary volunteers (n = 60, aged ≥70 years) were randomly assigned to either IATP-R or maintained sedentary lifestyle for 9...
July 2, 2018: International Journal of Clinical Practice
Hiroyuki Shimada, Sangyoon Lee, Masahiro Akishita, Koichi Kozaki, Katsuya Iijima, Kumiko Nagai, Shinya Ishii, Masamichi Tanaka, Hitomi Koshiba, Tomoki Tanaka, Kenji Toba
BACKGROUND: Although research indicates that a physically active lifestyle has the potential to prevent cognitive decline and dementia, the optimal type of physical activity/exercise remains unclear. The present study aimed to determine the cognitive benefits of a golf-training programme in community-dwelling older adults. METHODS: We conducted a randomised controlled trial between August 2016 and June 2017 at a general golf course. Participants included 106 Japanese adults aged 65 and older...
October 2018: Journal of Epidemiology and Community Health
Joshua Blair, Robert Barry, Philip I Murray, David J Moore, Alastair K Denniston
BACKGROUND: Non-infectious uveitis represents a sub-type of intraocular inflammation often associated with disorders of immune dysregulation. If untreated, the intraocular inflammation may progress to severe visual impairment and blindness. Current treatment is heavily reliant on systemic corticosteroid, often at doses associated with severe side effects. There is a need for efficacious corticosteroid-sparing immunomodulatory therapy for these patients. Current immunomodulators include various immunosuppressants and biologics but mammalian target of rapamycin (mTOR) inhibitors (such as sirolimus and everolimus) may also be contenders for this role...
June 9, 2018: Systematic Reviews
Mahmoud Fahmy, Mahmoud Abdel Karim, Sherif A Khaled, Ahmed Hazem Abdelazeem, Walid A Elnahal, Ashraf Elnahal
INTRODUCTION: Biomechanical studies have compared fixation methods in transverse acetabular fractures, yet there is not enough clinical data to suggest an optimal fixation method. The aim of this randomized controlled trail was to compare fracture stability in posterior plating alone versus posterior plating and anterior column lag-screw fixation in treatment of transverse and transverse with posterior wall acetabular fractures. METHODS: Thirty patients were randomized to one of two groups, either posterior fixation alone (single column group), or posterior plating and anterior fixation with percutaneous anterior column screw (double column group)...
May 24, 2018: Injury
Y Teuschl, H Ihle-Hansen, K Matz, A Dachenhausen, P Ratajczak, J Tuomilehto, M H Ursin, G Hagberg, B Thommessen, A R Øksengård, M Brainin
BACKGROUND AND PURPOSE: The aim of this pooled patient-level data analysis was to test if multidomain interventions, addressing several modifiable vascular risk factors simultaneously, are more effective than usual post-stroke care for the prevention of cognitive decline after stroke. METHODS: This pooled patient-level data analysis included two randomized controlled trials using a multidomain approach to target vascular risk factors in stroke patients and cognition as primary outcome...
September 2018: European Journal of Neurology: the Official Journal of the European Federation of Neurological Societies
Jihui Lyu, Wenjie Li, Xiangjiang Rong, Lian Wei, Nayan Huang, Mei Champ, Qian Xiong, Xueli Chen, Mo Li, Fangling Li
INTRODUCTION: Many studies suggest that Tai Chi exercise is a safe and appropriate mind-body exercise for older people and effectively slows down age-related cognitive decline. A set of bespoke Tai Chi exercise named 'Cognition Protecting Tai Chi' (CPT) has been created for older people with cognitive impairments by the research team of geriatricians, neurologists, rehabilitation specialists, experts of sports medicine and experienced practitioners of traditional Chinese medicine. This trial is designed to evaluate its effects on cognitive function, behaviour/moods, risk of falls and activities of daily living of the participants with mild dementia...
May 14, 2018: BMJ Open
Sarang Kim, Mitchell McMaster, Susan Torres, Kay L Cox, Nicola Lautenschlager, George W Rebok, Dimity Pond, Catherine D'Este, Ian McRae, Nicolas Cherbuin, Kaarin J Anstey
INTRODUCTION: It has been estimated that a 10%-25% reduction in seven key risk factors could potentially prevent 1.1-3.0 million Alzheimer's disease cases globally. In addition, as dementia is preceded by more subtle cognitive deficits which have substantial social and economic impact, effective preventative interventions would likely have more extensive benefits. The current study evaluates in primary care a multidomain risk-reduction intervention targeting adults with high risk of developing dementia...
March 17, 2018: BMJ Open
Heilok Cheng, Jielan Kong, Catherine Underwood, Peter Petocz, Vasant Hirani, Beryl Dawson, Fiona O'Leary
The loss of lean body mass, muscle strength and physical function causes significant problems in older adults. Protein and amino acid supplements can preserve muscle strength but the effect on function is variable. We conducted a systematic literature review and meta-analysis to investigate the effect of protein and amino acid supplementation on fat-free mass, muscle strength and physical function in malnourished, frail, sarcopenic, dependent or elderly with acute or chronic conditions, with or without rehabilitation exercise...
March 2018: British Journal of Nutrition
Deepak Thapa, Deepanshu Dhiman, Vanita Ahuja, Satinder Gombar, Ravi K Gupta
Background: Recent literature has established the role of stellate ganglion block (SGB) for management of acute postoperative pain. The effects of dexmedetomidine as an adjuvant to lignocaine in a preoperative SGB for postoperative pain relief have not been evaluated so far. Methods: The following randomised, double-blinded, control trail included 54 patients scheduled for upper limb orthopaedic surgery under general anaesthesia. Preoperative ultrasound-guided (USG) SGB was performed in all patients...
February 2018: British Journal of Pain
Geert Jan Biessels, Jolien Janssen, Esther van den Berg, Bernard Zinman, Mark A Espeland, Michaela Mattheus, Odd Erik Johansen
BACKGROUND: Type 2 diabetes mellitus is associated with cognitive dysfunction and an increased risk of dementia. Linagliptin is a glucose-lowering agent of the dipeptidyl peptidase-IV (DPP-IV) inhibitor class that is of particular interest for the prevention of accelerated cognitive decline, because it may potentially benefit the brain through pleiotropic effects, beyond glucose lowering. This paper presents the design of a study that aims to establish if linagliptin is superior to the sulfonylurea glimepiride in the prevention of accelerated cognitive decline in patients with type 2 diabetes mellitus...
January 15, 2018: BMC Neurology
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