scholarly journals Effects of a long-term home-based exercise training programme using minimal equipment vs. usual care in COPD patients: a study protocol for two multicentre randomised controlled trials (HOMEX-1 and HOMEX-2 trials)

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Anja Frei ◽  
Thomas Radtke ◽  
Kaba Dalla Lana ◽  
Julia Braun ◽  
Ramona M. Müller ◽  
...  
Keyword(s):  
Exercise Training ◽  
Usual Care ◽  
Randomised Controlled Trials ◽  
Training Programme ◽  
Controlled Trials ◽  
Home Based ◽  
Copd Patients ◽  
Randomised Controlled ◽  
Exercise Training Programme

scholarly journals The effect of a pre- and post- operative exercise programme versus standard care on physical fitness of patients with oesophageal and gastric cancer undergoing neoadjuvant treatment prior to surgery (The PERIOP-OG Trial): Study protocol for a randomised controlled trial.

2020 ◽  
Author(s):  
Roisin Tully ◽  
Lisa Loughney ◽  
Jarlath C Bolger ◽  
Jan Sorensen ◽  
Oliver J Mcanena ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Exercise Training ◽  
Physical Fitness ◽  
Usual Care ◽  
Cardiorespiratory Fitness ◽  
Standard Care ◽  
Controlled Trial ◽  
Training Programme ◽  
Randomised Controlled ◽  
Exercise Training Programme

Abstract Background: Advances in peri-operative oncological treatment, surgery and peri-operative care have improved survival for patients with oesophagogastric cancers. Neoadjuvant cancer treatment (NCT) reduces physical fitness, which may reduce both compliance and tolerance of NCT as well as compromising post-operative outcomes. This is particularly detrimental in a patient group where malnutrition is common and surgery is demanding. The aim of this trial is to assess the effect on physical fitness and clinical outcomes of a comprehensive exercise training programme in patients undergoing NCT and surgical resection for oesophagogastric malignancies. Methods: The PERIOP-OG trial is a pragmatic, multi-centre, randomised controlled trial comparing a programme of peri-operative exercise with standard care in patients with oesophagogastric cancers treated with NCT and surgery. The intervention group undergo a formal exercise training programme and the usual care group receive standard clinical care (no formal exercise advice). The training programme is initiated at cancer diagnosis, continued during NCT, between NCT and surgery, and then resumed again after surgery. All participants undergo assessments at: baseline, post-NCT, pre-surgery and at 4 and 10 weeks after surgery. The primary endpoint is cardiorespiratory fitness measured by demonstration of a 15% difference in 6-minute walk test assessed at the pre-surgery time point. Secondary endpoints include measures of physical health (upper and lower body strength tests), body mass index, frailty, activity behavior, psychological and health related quality of life outcomes. Exploratory endpoints include a health economics analysis, assessment of clinical health by post-operative morbidity scores, hospital length of stay, nutritional status, immune and inflammatory markers, and response to NCT. Rates of NCT toxicity, tolerance and compliance will also be assessed. Discussion: The PERIOP-OG trial will determine whether, when compared to usual care, exercise training initiated at diagnosis and continued during NCT, prior to surgery and then during recovery, can maintain or improve cardiorespiratory fitness and other physical, psychological and clinical health outcomes. This trial will inform both the prescription of exercise regimes as well as the design of a larger prehabilitation and rehabilitation trial to investigate whether exercise in combination with nutritional and psychological interventions elicit greater benefits.

scholarly journals The effect of a pre- and post- operative exercise programme versus standard care on physical fitness of patients with oesophageal and gastric cancer undergoing neoadjuvant treatment prior to surgery (The PERIOP-OG Trial): Study protocol for a randomised controlled trial.

2020 ◽  
Author(s):  
Roisin Tully ◽  
Lisa Loughney ◽  
Jarlath C Bolger ◽  
Jan Sorensen ◽  
Oliver J Mcanena ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Exercise Training ◽  
Physical Fitness ◽  
Usual Care ◽  
Cardiorespiratory Fitness ◽  
Standard Care ◽  
Controlled Trial ◽  
Training Programme ◽  
Randomised Controlled ◽  
Exercise Training Programme

Abstract Background: Advances in peri-operative oncological treatment, surgery and peri-operative care have improved survival for patients with oesophagogastric cancers. Neoadjuvant cancer treatment (NCT) reduces physical fitness, which may reduce both compliance and tolerance of NCT as well as compromising post-operative outcomes. This is particularly detrimental in a patient group where malnutrition is common and surgery is demanding. The aim of this trial is to assess the effect on physical fitness and clinical outcomes of a comprehensive exercise training programme in patients undergoing NCT and surgical resection for oesophagogastric malignancies. Methods: The PERIOP-OG trial is a pragmatic, multi-centre, randomised controlled trial comparing a programme of peri-operative exercise with standard care in patients with oesophagogastric cancers treated with NCT and surgery. The intervention group undergo a formal exercise training programme and the usual care group receive standard clinical care (no formal exercise advice). The training programme is initiated at cancer diagnosis, continued during NCT, between NCT and surgery, and then resumed again after surgery. All participants undergo assessments at: baseline, post-NCT, pre-surgery and at 4 and 10 weeks after surgery. The primary endpoint is cardiorespiratory fitness measured by demonstration of a 15% difference in 6-minute walk test assessed at the pre-surgery time point. Secondary endpoints include measures of physical health (upper and lower body strength tests), body mass index, frailty, activity behavior, psychological and health related quality of life outcomes. Exploratory endpoints include a health economics analysis, assessment of clinical health by post-operative morbidity scores, hospital length of stay, nutritional status, immune and inflammatory markers, and response to NCT. Rates of NCT toxicity, tolerance and compliance will also be assessed. Discussion: The PERIOP-OG trial will determine whether, when compared to usual care, exercise training initiated at diagnosis and continued during NCT, prior to surgery and then during recovery, can maintain or improve cardiorespiratory fitness and other physical, psychological and clinical health outcomes. This trial will inform both the prescription of exercise regimes as well as the design of a larger prehabilitation and rehabilitation trial to investigate whether exercise in combination with nutritional and psychological interventions elicit greater benefits.

scholarly journals The effect of a pre- and post- operative exercise programme versus standard care on physical fitness of patients with oesophageal and gastric cancer undergoing neoadjuvant treatment prior to surgery (The PERIOP-OG Trial): Study protocol for a randomised controlled trial.

2019 ◽  
Author(s):  
Roisin Tully ◽  
Lisa Loughney ◽  
Jarlath C Bolger ◽  
Jan Sorensen ◽  
Oliver J Mcanena ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Exercise Training ◽  
Physical Fitness ◽  
Usual Care ◽  
Cardiorespiratory Fitness ◽  
Standard Care ◽  
Controlled Trial ◽  
Training Programme ◽  
Randomised Controlled ◽  
Exercise Training Programme

Abstract Background Advances in peri-operative oncological treatment, surgery and peri-operative care have improved survival for patients with oesophagogastric cancers. Neoadjuvant cancer treatment (NCT) reduces physical fitness, which may reduce both compliance and tolerance of NCT as well as compromising post-operative outcomes. This is particularly detrimental in a patient group where malnutrition is common and surgery is demanding. The aim of this trial is to assess the effect on physical fitness and clinical outcomes of a comprehensive exercise training programme in patients undergoing NCT and surgical resection for oesophagogastric malignancies.Methods The PERIOP-OG trial is a pragmatic, multi-centre, randomised controlled trial comparing a programme of peri-operative exercise with standard care in patients with oesophagogastric cancers treated with NCT and surgery. The intervention group undergo a formal exercise training programme and the usual care group receive standard clinical care (no formal exercise advice). The training programme is initiated at cancer diagnosis, continued during NCT, between NCT and surgery, and then resumed again after surgery. All participants undergo assessments at: baseline, post-NCT, pre-surgery and at 4 and 10 weeks after surgery. The primary endpoint is cardiorespiratory fitness measured by demonstration of a 15% difference in 6-minute walk test assessed at the pre-surgery time point. Secondary endpoints include measures of physical health (upper and lower body strength tests), body mass index, activity behavior, psychological and health related quality of life outcomes. Exploratory endpoints include a health economics analysis, assessment of clinical health by post-operative morbidity scores, hospital length of stay, nutritional status, immune and inflammatory markers, and response to NCT. Rates of NCT toxicity, tolerance and compliance will also be assessed.Discussion The PERIOP-OG trial will determine whether, when compared to usual care, exercise training initiated at diagnosis and continued during NCT, prior to surgery and then during recovery, can maintain or improve cardiorespiratory fitness and other physical, psychological and clinical health outcomes. This trial will inform both the prescription of exercise regimes as well as the design of a larger prehabilitation and rehabilitation trial to investigate whether exercise in combination with nutritional and psychological interventions elicit greater benefits.

A Systematic Review of Cost-Effectiveness Analyses Alongside Randomised Controlled Trials of Acupuncture

2012 ◽  
Vol 30 (4) ◽  
pp. 273-285 ◽  
Author(s):  
Song-Yi Kim ◽  
Hyangsook Lee ◽  
Younbyoung Chae ◽  
Hi-Joon Park ◽  
Hyejung Lee
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Randomised Controlled Trials ◽  
Risk Of Bias ◽  
Economic Evaluations ◽  
Controlled Trials ◽  
German Studies ◽  
Life Years ◽  
Randomised Controlled ◽  
The Cost

Objective To summarise the evidence on the cost-effectiveness of acupuncture. Methods We identified full economic evaluations such as cost-effectiveness analysis (CEA), cost-utility analysis (CUA) and cost-benefit analysis (CBA) alongside randomised controlled trials (RCTs) that assessed the consequences and costs of acupuncture for any medical condition. Eleven electronic databases were searched up to March 2011 without language restrictions. Eligible RCTs were assessed using the Cochrane criteria for risk of bias and a modified version of the checklist for economic evaluation. The general characteristics and the results of each economic analysis such as incremental cost-effectiveness ratios (ICERs) were extracted. Results Of 17 included studies, nine were CUAs that measured quality-adjusted life years (QALYs) and eight were CEAs that assessed effectiveness of acupuncture based on improvements in clinical symptoms. All CUAs showed that acupuncture with or without usual care was cost-effective compared with waiting list control or usual care alone, with ICERs ranging from ¢3011/QALY (dysmenorrhoea) to ¢22 298/QALY (allergic rhinitis) in German studies, and from £3855/QALY (osteoarthritis) to £9951/QALY (headache) in UK studies. In the CEAs, acupuncture was beneficial at a relatively low cost in six European and Asian studies. All CUAs were well-designed with a low risk of bias, but this was not the case for CEAs. Conclusions Overall, this review demonstrates the cost-effectiveness of acupuncture. Despite such promising results, any generalisation of these results needs to be made with caution given the diversity of diseases and the different status of acupuncture in the various countries.

scholarly journals Updated systematic review of exercise studies in breast cancer survivors: attention to the principles of exercise training

2017 ◽  
Vol 53 (8) ◽  
pp. 504-512 ◽  
Author(s):  
Sarah E Neil-Sztramko ◽  
Kerri M Winters-Stone ◽  
Kelcey A Bland ◽  
Kristin L Campbell
Keyword(s):  
Breast Cancer ◽  
Systematic Review ◽  
Exercise Training ◽  
Cancer Survivors ◽  
Randomised Controlled Trials ◽  
Breast Cancer Survivors ◽  
Exercise Prescription ◽  
Controlled Trials ◽  
Exercise Interventions ◽  
Randomised Controlled

ObjectivesTo update our previous evaluation of the exercise interventions used in randomised controlled trials of breast cancer survivors in relation to (1) the application of the principles of exercise training in the exercise prescription; (2) the reporting of the components of the exercise prescription; and (3) the reporting of adherence of participants to the prescribed interventions.DesignSystematic review.Data sourcesThe OVID Medline, Embase, CINAHL and SPORTDiscus electronic databases were searched from January 2010 to January 2017.Eligibility criteriaRandomised controlled trials of at least 4 weeks of aerobic and/or resistance exercise in women diagnosed with breast cancer, reporting on physical fitness or body composition outcomes.ResultsSpecificity was appropriately applied by 84%, progression by 29%, overload by 38% and initial values by 67% of newly identified studies. Reversibility was reported by 3% anddiminishing returns by 22% of newly identified studies. No studies reported all components of the exercise prescription in the methods, or adherence to the prescribed intervention in the results. Reporting of reversibility has increased from 2010, but no other improvements in reporting were noted from the previous review.Summary/ConclusionNo studies of exercise in women with breast cancer attended to all principles of exercise training, or reported all components of the exercise prescription in the methods, or adherence to the prescription in the results. Full reporting of the exercise prescribed and completed is essential for study replication in research and translating research findings into the community, and should be prioritised in future trials.

scholarly journals IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage

BMJ ◽  
2013 ◽  
Vol 346 (jun18 3) ◽  
pp. f2820-f2820 ◽  
Author(s):  
J. A. Cook ◽  
P. McCulloch ◽  
J. M. Blazeby ◽  
D. J. Beard ◽  
D. Marinac-Dabic ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Surgical Innovation ◽  
Term Study ◽  
Long Term Study ◽  
Randomised Controlled ◽  
Ideal Framework

scholarly journals Measurement of long-term outcomes in observational and randomised controlled trials

2007 ◽  
Vol 191 (S50) ◽  
pp. s78-s84 ◽  
Author(s):  
Richard Hodgson ◽  
Chris Bushe ◽  
Robert Hunter
Keyword(s):  
Gold Standard ◽  
Observational Studies ◽  
Randomised Controlled Trials ◽  
Face Validity ◽  
Controlled Trials ◽  
Experimental Paradigm ◽  
Pragmatic Trials ◽  
Long Term Outcomes ◽  
Randomised Controlled

BackgroundRandomised controlled trials (RCTs) are the gold standard for evaluating treatment efficacy. However, the outcomes of RCTs often lackclinical utility and usually do not address real-world effectivenessAimsTo review how traditional RCTs may be triangulatedwith other methodologies such as observational studies and pragmatic trials by highlighting recently reported studies, outcomes used and their respective meritsMethodLiterature review focusing on drug treatmentResultsRecently reported observational and some pragmatic studies show a degree of consistency in reported results and use outcomes that have face validity for cliniciansConclusionsNo single experimental paradigm or outcome provides the necessary data to optimise treatment of mental illness in the clinical setting

Sign in / Sign up

Export Citation Format

Share Document