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Effects of Increased Physical Activity Before Thoracoabdominal Esophageal Surgery

Effekt av ökad Fysisk träning i Samband Med Thorakoabdominell Esofaguskirurgi

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03452319
Enrollment
100
Registered
2018-03-02
Start date
2017-12-01
Completion date
2023-08-30
Last updated
2023-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oesophageal Cancer

Keywords

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

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.

Interventions

OTHERPretraining

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

OTHERUsual care

Preoperative information

Sponsors

Göteborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Masking description

Assessor will not be aware of which group the patients are included in.

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

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
6 minutes walk testFrom inclusion to 3 months postoperativelyTest of physical capacity

Other

MeasureTime frameDescription
Postoperative recoveryFrom surgery to 1 year postoperativelyThe Postoperative Recovery Profile
SpirometryFrom inclusion to 3 months postoperativelyVital capacity
Respiratory muscle strengthFrom inclusion to 3 months postoperativelyMaximal Inspiratory Pressure and maximal expiratory pressure
Hand strengthFrom inclusion to 3 months postoperativelyHand strength (Jamar)
Leg strength- calf strengthFrom inclusion to 3 months postoperativelyHeel rise test
Physical functionFrom inclusion to 1 year postoperatively (The whole study period)Disability Rating Index
Rib cage range of motionFrom inclusion to 3 months postoperativelyChest excursion and Respiratory Movement Measurement Instrument
Level of physical activityFrom inclusion to 1 year postoperatively (The whole study period)Scale by Grimby and Frändin
Pain in the ribcageFrom 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
Generic Quality of lifeFrom inclusion to 1 year postoperatively (The whole study period)EORTC 3 modules
Leg strengthFrom inclusion to 3 months postoperativelyChair stands test

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026