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.

scholarly journals P-O04 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): A Randomised controlled trial

2021 ◽  
Vol 108 (Supplement_9) ◽  
Author(s):  
Lisa Loughney ◽  
Roisin Tully ◽  
Jarlath. C Bolger ◽  
Jan Sorensen ◽  
Oliver McAnena ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Physical Fitness ◽  
Usual Care ◽  
Grip Strength ◽  
Cardiorespiratory Fitness ◽  
Controlled Trial ◽  
Exercise Programme ◽  
Community Based ◽  
Sit To Stand ◽  
Randomised Controlled

Abstract Background Neoadjuvant cancer treatment (NCT) reduces physical fitness prior to surgery. Lower levels of fitness pre-operatively are associated with increased risk of post-operative morbidity and prolonged recovery. Exercise prehabilitation can optimise fitness for surgery.  There is a paucity of evidence regarding the role of community-based exercise programmes during oncological treatment of oesophagogastric malignancies. The aim of the PERIOP-OG trial was to investigate the effect of a community-based exercise prehabilitation programme on physical fitness and other clinical outcomes in patients undergoing NCT and surgical resection for oesophagogastric malignancies.  Methods Between March 2019 and December 2020, patients with oesophagogastric cancers requiring NCT and surgery were recruited to a multi-centre randomised controlled trial that compared an exercise prehabilitation group to a usual care control group. The exercise programme commenced following cancer diagnosis. All participants undertook assessments at baseline, end of NCT and pre-surgery. The primary endpoint was improvement in cardiorespiratory fitness, measured by the 6-min walk test (6MWT), from baseline and pre-surgery. Secondary endpoints included upper and lower body strength tests (grip strength and 10-sec sit to stand), EQ-5D-5L Health Questionnaire (EQ-5D-5L), Functional Assessment of Cancer Therapy (FACT-E) Questionnaire and Surgical Fear Questionnaire (SFQ). Results Seventy-one patients were randomised (exercise n = 36, control n = 35). Baseline characteristics between groups were comparable: mean age (p = 0.87) and sex (p = 0.24).  The difference-in-difference (DID) for the exercise prehabilitation showed a significant improvement in 6MWT pre-surgery compared to the usual care group from baseline to pre-surgery: mean (standard deviation) 522 m (17.4) to 582 m (20.1) vs. 498 m (18.2) to 506 m (28.7), p = 0.050. There was no significant DID in grip strength p = 0.770, 10-sec sit to stand (p = 0.100), EQ-5D-5L (p = 0.311), FACT-E (p = 0.105) or SFQ (p = 0.350). Conclusions The PERIOP-OG trial demonstrates that a community-based exercise prehabilitation programme initiated at diagnosis, continued during NCT and up to the time of surgery, significantly improves cardiorespiratory fitness. This community exercise prehabilitation model is feasible and sustainable and may provide a standardised framework for the prescription of exercise in oesophagogastric cancer patients.

scholarly journals The Wessex Fit-4-Cancer Surgery Trial (WesFit): a protocol for a factorial-design, pragmatic randomised-controlled trial investigating the effects of a multi-modal prehabilitation programme in patients undergoing elective major intra–cavity cancer surgery

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 952
Author(s):  
Malcolm West ◽  
Andrew Bates ◽  
Chloe Grimmett ◽  
Cait Allen ◽  
Richard Green ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Length Of Hospital Stay ◽  
Training Programme ◽  
Psychological Support ◽  
Tumour Regression ◽  
Operative Morbidity ◽  
Cardiopulmonary Exercise ◽  
Randomised Controlled ◽  
Exercise Training Programme

Background: Surgical resection remains the primary curative treatment for intra-cavity cancer. Low physical fitness and psychological factors such as depression are predictive of post–operative morbidity, mortality and length of hospital stay. Prolonged post-operative morbidity is associated with persistently elevated risk of premature death. We aim to investigate whether a structured, responsive exercise training programme, a psychological support programme or combined exercise and psychological support, delivered between treatment decision and major intra-cavity surgery for cancer, can reduce length of hospital stay, compared with standard care. Methods: WesFit is a pragmatic, 2x2 factorial-design, multi-centre, randomised-controlled trial, with planned recruitment of N=1560. Participants will be randomised to one of four groups. Group 1 (control) will receive usual pre-operative care, Group 2 (exercise) patients will undergo 2/3 aerobic, high-intensity interval training sessions per week supervised by personal trainers. Group 3 (psychological support) patients are offered 1 session per week at a local cancer support centre. Group 4 will receive both exercise and psychological support. All patients undergo baseline and pre-operative cardiopulmonary exercise testing, complete self-report questionnaires and will be followed up at 30 days, 12 weeks and 12 months post-operatively. Primary outcome is post-operative length-of-stay. Secondary outcomes include disability-adjusted survival at 1-year postoperatively, post-operative morbidity, and health-related quality of life. Exploratory investigations include objectively measured changes in physical fitness assessed by cardiopulmonary exercise test, disease-free and overall mortality at 1-year postoperatively, longer-term physical activity behaviour change, pre-operative radiological tumour regression, pathological tumour regression, pre and post-operative body composition analysis, health economics analysis and nutritional characterisation and its relationship to post-operative outcome. Conclusions: The WesFit trial will be the first randomised controlled study investigating whether an exercise training programme +/- psychological intervention results in improvements in clinical and patient reported outcomes in patients undergoing major inter-cavity resection of cancer. ClinicalTrials.gov registration: NCT03509428 (26/04/2018)

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