Effects of Increased Physical Activity Before Thoracoabdominal Esophageal Surgery

Göteborg University

Status: Completed

Conditions: Oesophageal Cancer

Treatments: Other: Usual care; Other: Pretraining

Study type: Interventional

Funder types: Other

Identifiers

NCT03452319

FoU VGR: 238651

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Pretraining

Experimental group

Description:

Increased physical activity daily Daily strength training Daily inspiratory and expiratory muscle training Standard care during hospital stay and continued training after discharge.

Treatment:

Other: Pretraining

Usual care treatment

Active Comparator group

Description:

Standard care including preoperative information and postoperative breathing exercises and mobilization during hospital stay.

Treatment:

Other: Usual care