Effects of Increased Physical Activity Before Thoracoabdominal Esophageal Surgery

Oesophageal Cancer Clinical Trial

Official title:

Effekt av ökad Fysisk träning i Samband Med Thorakoabdominell Esofaguskirurgi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03452319
• Other study ID #: FoU VGR: 238651
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: August 30, 2023

Study information

• Verified date: September 2023
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Oesophageal Cancer

Intervention

Other:
• Pretraining
Increased physical activity, and daily strength training and breathing exercises.
• Usual care
Preoperative information

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Spirometry	Vital capacity	From inclusion to 3 months postoperatively
Other	Respiratory muscle strength	Maximal Inspiratory Pressure and maximal expiratory pressure	From inclusion to 3 months postoperatively
Other	Hand strength	Hand strength (Jamar)	From inclusion to 3 months postoperatively
Other	Leg strength- calf strength	Heel rise test	From inclusion to 3 months postoperatively
Other	Leg strength	Chair stands test	From inclusion to 3 months postoperatively
Other	Rib cage range of motion	Chest excursion and Respiratory Movement Measurement Instrument	From inclusion to 3 months postoperatively
Other	Level of physical activity	Scale by Grimby and Frändin	From inclusion to 1 year postoperatively (The whole study period)
Other	Physical function	Disability Rating Index	From inclusion to 1 year postoperatively (The whole study period)
Other	Postoperative recovery	The Postoperative Recovery Profile	From surgery to 1 year postoperatively
Other	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)
Other	Generic Quality of life	EORTC 3 modules	From inclusion to 1 year postoperatively (The whole study period)
Primary	6 minutes walk test	Test of physical capacity	From inclusion to 3 months postoperatively