Clinical trial NCT03452319: Effects of Increased Physical Activity Before Thoracoabdominal Esophageal Surgery
Official title: Effekt av ökad Fysisk träning i Samband Med Thorakoabdominell Esofaguskirurgi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oesophageal Cancer
Keywords: Thoracoabdominal surgery
Physical Therapy
Inspiratory Muscle Training
Physical Activity
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 6 minutes walk test
timeFrame: From inclusion to 3 months postoperatively
Secondary outcomes:
Other outcomes:
measure: Spirometry
timeFrame: From inclusion to 3 months postoperatively
measure: Respiratory muscle strength
timeFrame: From inclusion to 3 months postoperatively
measure: Hand strength
timeFrame: From inclusion to 3 months postoperatively
measure: Leg strength- calf strength
timeFrame: From inclusion to 3 months postoperatively
measure: Leg strength
timeFrame: From inclusion to 3 months postoperatively
measure: Rib cage range of motion
timeFrame: From inclusion to 3 months postoperatively
measure: Level of physical activity
timeFrame: From inclusion to 1 year postoperatively (The whole study period)
measure: Physical function
timeFrame: From inclusion to 1 year postoperatively (The whole study period)
measure: Postoperative recovery
timeFrame: From surgery to 1 year postoperatively
measure: Pain in the ribcage
timeFrame: From inclusion to 1 year postoperatively (The whole study period)
measure: Generic Quality of life
timeFrame: From inclusion to 1 year postoperatively (The whole study period)
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska Academy at Gothenburg university, Sweden
name: Monika Fagevik Olsén, phD
role: PRINCIPAL_INVESTIGATOR
References: