ClinicalTrials.gg
CompletedNCT03452319Updated Oct 2, 2023

Effects of Increased Physical Activity Before Thoracoabdominal Esophageal Surgery

An interventional study of Pretraining and Usual care in Oesophageal Cancer, sponsored by Göteborg University. Completed at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2023-10-02.

Sponsored by Göteborg University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 30 studies in Esophageal Neoplasms with a site in Sweden — 8 open to participants now, 8 under way, 1 of them phase 3. Esophageal Neoplasms · Sweden.

Enrollment
7th of 19
100 · median 80
Started
2017
with 1 other
No phase
10 of 30
2 open now
Registered
18th of 30
by date

Among the 30 studies in Esophageal Neoplasms with a site in Sweden, this one is the 7th largest by enrollment of the 19 interventional ones that give a count, is one of 2 that started in 2017, is one of 10 with no phase, and was the 18th registered.

Esophageal Neoplasms

1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.

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Open to participants now

8 of the 30 studies in Esophageal Neoplasms with a site in Sweden are open now. Recruiting first, the newest first:

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All 8 open studies →

A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →

Who these studies take

Of the 387 Esophageal Neoplasms studies recruiting now, 245 (63%) set no upper age limit and 75 (19%) stop at 75 or younger; 19 take children under 18; 36 take healthy volunteers.

This study: all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Oesophageal Cancer

Keywords

  • Thoracoabdominal surgery
  • Physical Therapy
  • Inspiratory Muscle Training
  • Physical Activity
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients scheduled to undergo thoracoabdominal oesophagus resection at one of the five included centra

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Pretraining

    Increased physical activity daily Daily strength training Daily inspiratory and expiratory muscle training Standard care during hospital stay and continued training after discharge.

    Other: Pretraining

  • Active comparator
    Usual care treatment

    Standard care including preoperative information and postoperative breathing exercises and mobilization during hospital stay.

    Other: Usual care

Interventions

  • OtherPretraining

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

  • OtherUsual care

    Preoperative information

06

What researchers measure

Primary outcomes

  1. 6 minutes walk test

    Test of physical capacity

    Time frame: From inclusion to 3 months postoperatively

Other outcomes

  1. Spirometry

    Vital capacity

    Time frame: From inclusion to 3 months postoperatively

  2. Respiratory muscle strength

    Maximal Inspiratory Pressure and maximal expiratory pressure

    Time frame: From inclusion to 3 months postoperatively

  3. Hand strength

    Hand strength (Jamar)

    Time frame: From inclusion to 3 months postoperatively

  4. Leg strength- calf strength

    Heel rise test

    Time frame: From inclusion to 3 months postoperatively

  5. Leg strength

    Chair stands test

    Time frame: From inclusion to 3 months postoperatively

  6. Rib cage range of motion

    Chest excursion and Respiratory Movement Measurement Instrument

    Time frame: From inclusion to 3 months postoperatively

  7. Level of physical activity

    Scale by Grimby and Frändin

    Time frame: From inclusion to 1 year postoperatively (The whole study period)

  8. Physical function

    Disability Rating Index

    Time frame: From inclusion to 1 year postoperatively (The whole study period)

  9. Postoperative recovery

    The Postoperative Recovery Profile

    Time frame: From surgery to 1 year postoperatively

  10. Pain in the ribcage

    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)

  11. Generic Quality of life

    EORTC 3 modules

    Time frame: From inclusion to 1 year postoperatively (The whole study period)

07

Study locations

1 site
  • Sahlgrenska University Hospital
    Gothenburg, 413 45, Sweden
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Dec 2022, 60 months.

Of 209 non-industry interventional studies with no phase under Esophageal Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 96. This study's 60 months is above that.

Counting every sponsor, half of 218 studies reached it within 46 months; a quarter within 23 and three quarters within 96.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 23, 2018
First posted
Mar 2, 2018
StartActual
Dec 1, 2017
Primary completionActual
Dec 31, 2022
CompletionActual
Aug 30, 2023
Last update
Oct 2, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03452319
Responsible party
Sponsor
First posted
Mar 2, 2018
Start date
Dec 1, 2017
Primary completion
Dec 31, 2022
Completion
Aug 30, 2023
Last update
Oct 2, 2023

Study contacts

Monika Fagevik Olsén, phD
principal investigator · Sahlgrenska Academy at Gothenburg university, Sweden

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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