Oesophageal CancerNCT03452319
Effects of Increased Physical Activity Before Thoracoabdominal Esophageal Surgery
A study testing Pretraining in people with Oesophageal Cancer, run by Göteborg University at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oesophageal Cancer
- What is being tested?
- Pretraining
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2017to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients scheduled to undergo thoracoabdominal oesophagus resection at one of the five included centra
Who cannot join
- < 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Oesophageal Cancer
- Being tested
- Pretraining, Usual care
- Keywords
- Thoracoabdominal surgery, Physical Therapy, Inspiratory Muscle Training, Physical Activity
- Medical subject headings
- Esophageal Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PretrainingOther
Increased physical activity, and daily strength training and breathing exercises.
Usual careOther
Preoperative information
| Study group | Role | What they receive |
|---|---|---|
| Pretraining | Experimental | Increased physical activity daily Daily strength training Daily inspiratory and expiratory muscle training Standard care during hospital stay and continued training after discharge. Receives: Other: Pretraining |
| Usual care treatment | Active comparator | Standard care including preoperative information and postoperative breathing exercises and mobilization during hospital stay. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minutes walk test
Test of physical capacity
Measured: From inclusion to 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start1 Dec 2017
- Primary completion31 Dec 2022
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oesophageal CancerStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monika Fagevik Olsén, phD, Principal investigator, Sahlgrenska Academy at Gothenburg university, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452319
- Sponsor's protocol ID
- FoU VGR: 238651
- Status last verified
- Sep 2023
- First submitted
- 23 Feb 2018
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fagevik Olsen M, Lothgren S, Trolle U, Elf E, Toomvali-Petersson S, Hermansson M, Hammerlid E, Smedh U. Positive effects of a perioperative training intervention in Ivor Lewis oesophageal surgery: a randomised, controlled multicentre trial. BMC Surg. 2025 Dec 11;26(1):34. doi: 10.1186/s12893-025-03416-4.
PubMed 41372748
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effekt av ökad Fysisk träning i Samband Med Thorakoabdominell Esofaguskirurgi
- ClinicalTrials.gov ID
- NCT03452319
- Acronym / sponsor ID
- FoU VGR: 238651
- Conditions
- Oesophageal Cancer
- Keywords
- Thoracoabdominal surgery, Physical Therapy, Inspiratory Muscle Training, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 2 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Pretraining | Experimental | Other: PretrainingIncreased physical activity daily Daily strength training Daily inspiratory and expiratory muscle training Standard care during hospital stay and continued training after discharge. |
| Usual care treatment | Active comparator | Other: Usual careStandard care including preoperative information and postoperative breathing exercises and mobilization during hospital stay. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled to undergo thoracoabdominal oesophagus resection at one of the five included centra
Key exclusion criteria (4 listed)
- < 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PretrainingIncreased physical activity, and daily strength training and breathing exercises. | Other | Pretraining |
| Usual carePreoperative information | Other | Usual care treatment |
Primary outcome
6 minutes walk test
Time frame: From inclusion to 3 months postoperatively
Test of physical capacity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Derived from this study: PubMed 41372748Fagevik Olsen M, Lothgren S, Trolle U, Elf E, Toomvali-Petersson S, Hermansson M, Hammerlid E, Smedh U. Positive effects of a perioperative training intervention in Ivor Lewis oesophageal surgery: a randomised, controlled multicentre trial. BMC Surg. 2025 Dec 11;26(1):34. doi: 10.1186/s12893-025-03416-4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika Fagevik Olsén, phD principal investigator
Sahlgrenska Academy at Gothenburg university, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pretraining in people with Oesophageal Cancer, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minutes walk test (time frame: From inclusion to 3 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03452319, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.