Effects of Increased Physical Activity Before Thoracoabdominal Esophageal Surgery

Not Applicable

Completed

• Conditions: Oesophageal Cancer
• Interventions: Other: Usual care; Other: Pretraining

• Registration Number: NCT03452319
• Lead Sponsor: Göteborg University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2018-02-23
• Study First Submitted QC: 2018-03-01
• Study First Posted: 2018-03-02
• Primary Completion: 2022-12-31
• Study Completion: 2023-08-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-29
• Last Update Posted: 2023-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care treatment	Usual care	Standard care including preoperative information and postoperative breathing exercises and mobilization during hospital stay.
Pretraining	Pretraining	Increased physical activity daily Daily strength training Daily inspiratory and expiratory muscle training Standard care during hospital stay and continued training after discharge.

Primary Outcome Measures

Name	Time	Method
6 minutes walk test	From inclusion to 3 months postoperatively	Test of physical capacity

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden