Effects of Increased Physical Activity Before Thoracoabdominal Esophageal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2023-08-30

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.

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Detailed Description

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Conditions

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Oesophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Assessor will not be aware of which group the patients are included in.

Study Groups

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Pretraining

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

Group Type EXPERIMENTAL

Pretraining

Intervention Type OTHER

Increased physical activity, and daily strength training and breathing exercises.

Usual care treatment

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

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Preoperative information

Interventions

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Pretraining

Increased physical activity, and daily strength training and breathing exercises.

Intervention Type OTHER

Usual care

Preoperative information

Intervention Type OTHER

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No