Effects of Increased Physical Activity Before Thoracoabdominal Esophageal Surgery

Effekt av ökad Fysisk träning i Samband Med Thorakoabdominell Esofaguskirurgi

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.

Study Overview

• Status: Completed
• Conditions: Oesophageal Cancer
• Intervention / Treatment: Other: Pretraining; Other: Usual care

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 413 45
    • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pretraining; 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; Increased physical activity, and daily strength training and breathing exercises.
Active Comparator: Usual care treatment; Standard care including preoperative information and postoperative breathing exercises and mobilization during hospital stay.	Other: Usual care; Preoperative information

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minutes walk test	Test of physical capacity	From inclusion to 3 months postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spirometry	Vital capacity	From inclusion to 3 months postoperatively
Respiratory muscle strength	Maximal Inspiratory Pressure and maximal expiratory pressure	From inclusion to 3 months postoperatively
Hand strength	Hand strength (Jamar)	From inclusion to 3 months postoperatively
Leg strength- calf strength	Heel rise test	From inclusion to 3 months postoperatively
Leg strength	Chair stands test	From inclusion to 3 months postoperatively
Rib cage range of motion	Chest excursion and Respiratory Movement Measurement Instrument	From inclusion to 3 months postoperatively
Level of physical activity	Scale by Grimby and Frändin	From inclusion to 1 year postoperatively (The whole study period)
Physical function	Disability Rating Index	From inclusion to 1 year postoperatively (The whole study period)
Postoperative recovery	The Postoperative Recovery Profile	From surgery to 1 year postoperatively
Pain in the ribcage	Numeric rating scale, Scale from 0-10 where 0 indicates no pain and 10 worst imaginable pain	From inclusion to 1 year postoperatively (The whole study period)
Generic Quality of life	EORTC 3 modules	From inclusion to 1 year postoperatively (The whole study period)

Collaborators and Investigators

• Sponsor: Göteborg University
• Investigators: Principal Investigator: Monika Fagevik Olsén, phD, Sahlgrenska Academy at Gothenburg university, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: February 23, 2018
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (Actual): March 2, 2018

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Physical Activity; Physical Therapy; Inspiratory Muscle Training; Thoracoabdominal surgery
• Other Study ID Numbers: FoU VGR: 238651

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No