Effects of Increased Physical Activity Before Thoracoabdominal Esophageal Surgery

Study Overview
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Brief Summary
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Thoracoabdominal oesophageal resection for cancer is a procedure with high risks for complications, and patients' preoperative status is a crucial factor for outcome. There are only a few studies that evaluate the effect of preoperative intervention, including physical exercises and breathing exercises, after this type of surgery. The aim of the study is therefore to evaluate the effect of a training intervention before resection of the oesophagus. One hundred patients scheduled for oesophagus resection according to Ivor-Lewis from five different hospitals in Sweden will be included. The patients will be randomized to an intervention group or a control group. The training intervention starts directly after preoperative radiotherapy and chemotherapy are given and lasts until three months postoperatively. Intervention includes increased physical activity, strength training and respiratory muscle training. At inclusion and three months after discharge, the patients will undergo tests of physical function and lung function. In addition, they will fill in questionnaires concerning level of physical function, level of physical activity and quality of life. These questionnaires will also be answered one year after surgery.

Official Title
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Effekt av ökad Fysisk träning i Samband Med Thorakoabdominell Esofaguskirurgi

Conditions
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Oesophageal Cancer

Intervention / Treatment
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* Other: Pretraining
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled to undergo thoracoabdominal oesophagus resection at one of the five included centra Exclusion Criteria: < two weeks between inclusion and surgery benign reason for surgery difficulties in speaking and reading Swedish other injury or disease limiting the ability to perform the intervention.
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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A single blind, randomized, controlled, intervention study. Evaluation of the addition of increased physical activity and respiratory muscle training for patients undergoing thoracoabdominal esophagus resection compared to standard care
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pretraining<br>Increased physical activity daily Daily strength training Daily inspiratory and expiratory muscle training Standard care during hospital stay and continued training after discharge. | Other: Pretraining<br>* Increased physical activity, and daily strength training and breathing exercises.<br>|
| Active Comparator: Usual care treatment<br>Standard care including preoperative information and postoperative breathing exercises and mobilization during hospital stay. | Other: Usual care<br>* Preoperative information<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minutes walk test | Test of physical capacity | From inclusion to 3 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracoabdominal surgery, Physical Therapy, Inspiratory Muscle Training, Physical Activity