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

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)

Recovery of the decline in activities of daily living after hospitalization through an individualized exercise programme: Secondary Analysis of a Randomized Clinical Trial

Background During the period of hospitalization patients can develop functional decline. The main aim of our study was to assess the natural trajectory of each Activity of Daily Living (ADL) and to assess how in-hospital exercise could influence short-term trajectory of ADLs. Methods Acutely hospitalized patients (n=297, 56.5% women) were randomly assigned to the intervention or control (usual care) group within the first 48 hours of admission. An exercise training programme was prescribed in two daily sessions (morning and evening) of 20 minutes duration during 5–7 consecutive days for the intervention group. The primary end-point was the change in every ADL (assessed with the Barthel Index) from 2 weeks before admission to hospital discharge. Results Acute hospitalization per se led to significant in-patient’s functional ability impairment in ADLs during hospitalization, whereas the exercise intervention reversed this trend (3.7 points; 95% CI, 0.5 to 6.8 points). After analyzing the trajectory of each one of the ADLs, patients in the control group significantly worsened all activities, but with a different degree of loss. For the between-group analysis, significant differences were obtained in many ADLs including bathing, dressing, grooming, bladder control, toilet use, transfers, mobility and climbing stairs (p<0.05). The control group had the greatest impairment in all domains analyzed (i.e., feeding, bathing, dressing, grooming, bowel control, bladder control, toilet use, transfers, mobility, and climbing stairs), p<0.05. Conclusions An individualized multicomponent exercise training programme in older adults is effective to reverse the loss of specific ADLs that frequently occurs during hospitalization. Each patient profile should receive an individualized prescription of exercise during hospitalizations.

A qualitative study exploring the effects of participation in a community-based pre-operative exercise programme on perceived wellbeing and quality of life in people with newly diagnosed prostate cancer: A pilot study (Preprint)

BACKGROUND People with a newly diagnosed prostate cancer are often treated by surgery. The time window between cancer diagnosis and surgery causes high levels of uncertainty and stress, which negatively impact quality of life (QoL). OBJECTIVE To explore the experience of participating in a community-based pre-operative exercise programme (in the time between cancer diagnosis and surgery) and its impact on perceived wellbeing and QoL in people with newly diagnosed prostate cancer. METHODS Eleven men diagnosed with a new prostate cancer diagnosis were recruited and undertook a prescribed community-based pre-operative exercise training programme in the time available prior to surgery. Following completion of the pre-operative exercise programme (within 1 week before surgery), participants took part in one semi-structured interview which explored four broad QoL domains: physical; psychological; social; and spiritual wellbeing. Data were analysed using thematic analysis (a bottom up/inductive analysis). RESULTS Data supported four main themes. Participation in the community-based pre-operative exercise training programme (over a mean (SD) of 4 (2) weeks) provided participants with: 1) a teachable moment; 2) a journey of preparation; 3) provided them with a sense of optimism; and 4) social connectedness. CONCLUSIONS This community-based pre-operative exercise training programme enhanced wellbeing and served as an opportunity to improve perceived QoL. Further research is required to explore this in a larger sample. CLINICALTRIAL N/A

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.

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.

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.

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.

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.

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 qualitative study exploring the effects of participation in a community-based pre-operative exercise programme on perceived wellbeing and quality of life in people with newly diagnosed prostate cancer: A pilot study

Purpose: People with a newly diagnosed prostate cancer are often treated by surgery. The time window between cancer diagnosis and surgery causes high levels of uncertainty and stress, which negatively impact quality of life (QoL). This study explored the experience of participating in a community-based pre-operative exercise programme (in the time between cancer diagnosis and surgery) and its impact on perceived wellbeing and QoL in people with newly diagnosed prostate cancer.Methods: Eleven men diagnosed with a new prostate cancer diagnosis were recruited and undertook a prescribed community-based pre-operative exercise training programme in the time available prior to surgery. Following completion of the pre-operative exercise programme (within 1 week before surgery), participants took part in one semi-structured interview which explored four broad QoL domains: physical; psychological; social; and spiritual wellbeing. Data were analysed using thematic analysis (a bottom up/inductive analysis).Results: Data supported four main themes. Participation in the community-based pre-operative exercise training programme (over a mean (SD) of 4 (2) weeks) provided participants with: 1) a teachable moment; 2) a journey of preparation; 3) provided them with a sense of optimism; and 4) social connectedness.Conclusion: This community-based pre-operative exercise training programme enhanced wellbeing and served as an opportunity to improve perceived QoL. Further research is required to explore this in a larger sample.