Effects of Increased Physical Activity Before Thoracoabdominal Esophageal Surgery

NCT03452319 | Completed

• 1 other identifier: FoU VGR: 238651
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Oesophageal Cancer

Keywords

Thoracoabdominal surgery; Physical Therapy; Inspiratory Muscle Training; Physical Activity

Outcome Measures

Primary Outcomes (1)

• 6 minutes walk test

  Test of physical capacity

  From inclusion to 3 months postoperatively

Other Outcomes (11)

• Spirometry

  From inclusion to 3 months postoperatively

• Respiratory muscle strength

  From inclusion to 3 months postoperatively

• Hand strength

  From inclusion to 3 months postoperatively

Study Arms (2)

Pretraining

EXPERIMENTAL

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

Usual care treatment

ACTIVE COMPARATOR

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

Other: Usual care

Interventions

Pretraining OTHER

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

Pretraining

Usual care OTHER

Preoperative information

Usual care treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo thoracoabdominal oesophagus resection at one of the five included centra

You may not qualify if:

• benign reason for surgery
• difficulties in speaking and reading Swedish
• other injury or disease limiting the ability to perform the intervention.

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Related Publications (1)

• Fagevik Olsen M, Lothgren S, Trolle U, Elf E, Toomvali-Petersson S, Hermansson M, Hammerlid E, Smedh U. Positive effects of a perioperative training intervention in Ivor Lewis oesophageal surgery: a randomised, controlled multicentre trial. BMC Surg. 2025 Dec 11. doi: 10.1186/s12893-025-03416-4. Online ahead of print.

  PMID: 41372748 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Behavior

Study Officials

• Monika Fagevik Olsén, phD

  Sahlgrenska Academy at Gothenburg university, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Assessor will not be aware of which group the patients are included in.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: March 2, 2018
• Study Start: December 1, 2017
• Primary Completion: December 31, 2022
• Study Completion: August 30, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

SE (1)