Skip to main content
OpenTrials
Completed

NCT Number: NCT03452319

Effects of Increased Physical Activity Before Thoracoabdominal Esophageal Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pretraining

Other

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

Usual Care

Other

Preoperative information

Primary outcomes

  1. 6 minutes walk test

    Time frame: From inclusion to 3 months postoperatively

    Test of physical capacity

Other outcomes

  1. Spirometry

    Time frame: From inclusion to 3 months postoperatively

    Vital capacity

  2. Respiratory muscle strength

    Time frame: From inclusion to 3 months postoperatively

    Maximal Inspiratory Pressure and maximal expiratory pressure

  3. Hand strength

    Time frame: From inclusion to 3 months postoperatively

    Hand strength (Jamar)

  4. Leg strength- calf strength

    Time frame: From inclusion to 3 months postoperatively

    Heel rise test

  5. Leg strength

    Time frame: From inclusion to 3 months postoperatively

    Chair stands test

  6. Rib cage range of motion

    Time frame: From inclusion to 3 months postoperatively

    Chest excursion and Respiratory Movement Measurement Instrument

  7. Level of physical activity

    Time frame: From inclusion to 1 year postoperatively (The whole study period)

    Scale by Grimby and Frändin

  8. Physical function

    Time frame: From inclusion to 1 year postoperatively (The whole study period)

    Disability Rating Index

  9. Postoperative recovery

    Time frame: From surgery to 1 year postoperatively

    The Postoperative Recovery Profile

  10. Pain in the ribcage

    Time frame: From inclusion to 1 year postoperatively (The whole study period)

    Numeric rating scale, Scale from 0-10 where 0 indicates no pain and 10 worst imaginable pain

  11. Generic Quality of life

    Time frame: From inclusion to 1 year postoperatively (The whole study period)

    EORTC 3 modules

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

Effekt av ökad Fysisk träning i Samband Med Thorakoabdominell Esofaguskirurgi

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Mar 2, 2018
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.