Prehabilitation for Gastrectomy

Study Overview
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Brief Summary
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Prehabilitation has been demonstrated to be an effective strategy to improve outcomes in patients undergoing some of the abdominal operations. It may increase the physical capacity of the patient, improve postoperative quality of life and even decrease the postoperative morbidity. Currently, the most effective strategy seems to be a trimodal prehabilitation which includes: 1) Nutritional support 2) Psychological support and 3) Physical training.

Detailed Description
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This study will investigate personalized trimodal prehabilitation for patients undergoing gastrectomy for gastric cancer. Prehabilitation group: Patients will undergo 6 Minutes Walking Test (6-MWT), spiroergometry (VO2 max; AT), a grip strength test, a timed Up & Go (TUG) test, 10 m sprint test and sit to stand test before and after prehabilitation. The trimodal intervention will involve: Nutritional intervention: The dietetic physician will perform physical examination and evaluation of the nutritional status to provide individualized care to each patient. Patients will receive personalized recommendations for the prevention or correction of malnutrition. Psychological intervention: Patients will undergo consultation by specialized onco-psychologist. The anxiety and depression level will be evaluated by HAD score and patients will be trained to perform techniques, such as relaxation to reduce and manage anxiety on at home basis. The psychologist also will enhance patients' motivation to comply with the exercise and nutritional aspects of the intervention. Exercise intervention: Patients will be consulted by PM&R physicians and physiotherapists and personalized exercise plans will be developed according to the results of 6MWT, AT and VO2peak. Exercises will focus on skeletal muscles and cardiopulmonary function training and the exercises feasible at home basis will be selected. All patients will undergo three supervised training sessions to learn the correct exercise techniques. All patients will be routinely contacted to ensure compliance with prehabilitation program. Patients scheduled for surgery first by multidisciplinary tumor board will undergo 4 weeks prehabilitation program, while patients scheduled for perioperative chemotherapy will undergo prehabilitation while neoadjuvant treatment will be administered. Control group: Patients will also undergo 6 Minutes Walking Test (6-MWT), spiroergometry (VO2 max; AT), a grip strength test, a timed Up & Go (TUG) test, 10 m sprint test and sit to stand test before surgery or before and after neoadjuvant chemotherapy. Patients will not undergo prehabilitation.

Official Title
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Personalized Trimodal Prehabilitation for Gastrectomy

Conditions
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Gastric Cancer

Intervention / Treatment
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* Other: Prehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient ≥ 18 years old Patient agrees to participate in a clinical study Patient requires surgical treatment for gastric cancer Exclusion Criteria: Patient requiring surgical treatment for recurrent gastric cancer Patient condition not allowing to postpone surgery for at least 4 weeks Patients physical or mental condition which will not allow the patient to participate in prehabilitation program

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation group<br>Patients in the experimental group will undergo prehabilitation before the elective surgery for gastric cancer. | Other: Prehabilitation<br>* Patients will undergo 6 Minutes Walking Test (6-MWT), spiroergometry (VO2 max; AT), a grip strength test, a timed Up & Go (TUG) test, 10 m sprint test and sit to stand test before and after prehabilitation. The trimodal intervention will involve: Nutritional intervention Psychological intervention Exercise intervention<br>|
| No Intervention: Control group<br>Patients in the control group will not undergo prehabilitation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morbidity rate by Clavien-Dindo |  | At 90 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical status by Spiroergometry |  | Baseline, pre-surgery, 3, 6 and 12 months after surgery | 
| Physical status by International Physical Activity Questionnaire (IPAQ) |  | Baseline, pre-surgery, 3, 6 and 12 months after surgery | 
| Postoperative mortality rate |  | At 30 and 90 days postoperatively | 
| Nutritional status by albumin level |  | Baseline, pre-surgery, 3, 6 and 12 months after surgery | 
| Quality of Life by EORTC questionnaires |  | Baseline, pre-surgery, 3, 6 and 12 months after surgery | 
| Percentage of patients reaching the complete oncological treatment fixed in a multidisciplinary tumour board (including preoperative chemotherapy, surgery and postoperative chemotherapy) |  | 12 months after surgery | 
| Physical status by grip strength test |  | Baseline, pre-surgery, 3, 6 and 12 months after surgery | 
| Physical status by 6 minutes walk test |  | Baseline, pre-surgery, 3, 6 and 12 months after surgery | 
| Physical status by the sit to stand test |  | Baseline, pre-surgery, 3, 6 and 12 months after surgery | 
| Physical status by the timed up&go test |  | Baseline, pre-surgery, 3, 6 and 12 months after surgery | 
| Psychological status by Hospital Anxiety and Depression Scale (HADS). |  | Baseline, pre-surgery, 3, 6 and 12 months after surgery |