Sahlgrenska University Hospital
Gothenburg, 413 45, Sweden
NCT Number: NCT03452319
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.
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Interventional
Not applicable
Gothenburg, 413 45, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Increased physical activity, and daily strength training and breathing exercises.
Preoperative information
Time frame: From inclusion to 3 months postoperatively
Test of physical capacity
Time frame: From inclusion to 3 months postoperatively
Vital capacity
Time frame: From inclusion to 3 months postoperatively
Maximal Inspiratory Pressure and maximal expiratory pressure
Time frame: From inclusion to 3 months postoperatively
Hand strength (Jamar)
Time frame: From inclusion to 3 months postoperatively
Heel rise test
Time frame: From inclusion to 3 months postoperatively
Chair stands test
Time frame: From inclusion to 3 months postoperatively
Chest excursion and Respiratory Movement Measurement Instrument
Time frame: From inclusion to 1 year postoperatively (The whole study period)
Scale by Grimby and Frändin
Time frame: From inclusion to 1 year postoperatively (The whole study period)
Disability Rating Index
Time frame: From surgery to 1 year postoperatively
The Postoperative Recovery Profile
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
Time frame: From inclusion to 1 year postoperatively (The whole study period)
EORTC 3 modules
Göteborg University
Other
Effekt av ökad Fysisk träning i Samband Med Thorakoabdominell Esofaguskirurgi
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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.
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