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CompletedNCT02335970Updated Jan 6, 2020

Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery

An interventional study of Training group in Oesophagus Cancer, sponsored by Göteborg University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-06.

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

From the registry’s dates

  • Registered 9 years 3 months after the study started (first participant enrolled Sep 2005, registered Dec 2014).
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study evaluates the effect of a training intervention after thoracoabdominal resection of the oesophagus. Half of the patients scheduled for thoracoabdominal oesophagus surgery were randomized to an intervention group while the other half a control group.

Read the detailed description

It is well known that thoracoabdominal oesophageal resection for cancer is a procedure with high risks for complications. Earlier trials have shown that respiratory restrictions persist after the operation as well as lower physical function, range of motion in the rib-cage and limitations in activities in daily living. There are, however, only two clinical studies that evaluate postoperative breathing exercises and none evaluating any other rehabilitation interventions.

In other types of extensive surgery that may affect mobility with trauma to muscles and bone structures in the thorax and thoracic spinal column, there is strong evidence that speaks for an active rehabilitation approach in favour of a less active one.

The intervention evaluated was a rehabilitation program including exercises to restore lung function, range of motion in the thoracic spine and shoulders and strength exercises for the back extensors, shoulders and legs.

02

Conditions studied

  • Oesophagus Cancer

Keywords

  • Pain
  • Range of motion
  • Quality of life
03

In context

Esophageal Neoplasms

1,631 studies on the registry are indexed under Esophageal Neoplasms; 469 are open to participants now.

This study's enrollment of 64 is close to the median of 60 across 1,198 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Göteborg University is the lead sponsor of 270 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
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 for thoracoabdominal oesophageal resection
  • Ability to perform 90 W during a sub-maximal bicycle test
  • Ability to speak Swedish

Exclusion criteria

Exclusion Criteria:

  • Serious untreated cardiac disease that may be critical
  • Musculoskeletal or neurological disease or trauma affecting respiration or range of motion in the rib cage
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    Training group

    Training program: Daily exercises for 3 months

    Other: Training group

  • No intervention
    Controls

    Standard care

Interventions

  • OtherTraining group

    After 1 week * Chest expansions * Static thoracic extension in prone * Lateral flexion of the spine in standing * Bilateral shoulder flexion * Shoulder external rotation of shoulders * Rotation of the thoracic spine in sitting * Static back extensor strength in prone After 1 month * Thoracic extension, rotation and flexion abduction * Hand in neck and in back * Bilateral active flexion abduction * Strength training of leg muscles * Static back extensor strength After 2 months * Strength training of legs and back muscles * Push-ups against a wall * Thoracic extension in sitting and standing * Thoracic rotation in lying * Stretching of mm. pectoralis Training was performed daily with 10 rep of each exercise

06

What researchers measure

Primary outcomes

  1. Degree of physical disability estimated by the Disability Rating Index (DRI)

    12 items covering activities from dressing and going for walks to lifting heavy objects and exercising. The item responses were rated on visual analogue scales (0-100)

    Time frame: 3 months

Secondary outcomes

  1. Pain in the neck, rib cage and shoulders (visual analogue scale)

    Estimated on a 100-mm visual analogue scale

    Time frame: 3 months

  2. FVC (Forced Vital Capacity)

    Forced Vital Capacity performed in a standardised manner

    Time frame: 3 months

  3. Range of motion

    Thorax expansion, back flexion, extension and lateral flexion, shoulder flexion and abduction

    Time frame: 3 months

  4. Physical function (Time stand test and heel rise test)

    Time stand test and heel rise test

    Time frame: 3 months

  5. Physical Activity (six-level scale)

    A six-level scale where low figures indicate a sedentary and a high score an active lifestyle according to Grimby et al

    Time frame: 3 months

  6. Quality of Life by EORTC QLQ-C30

    European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core -30 version 3.0. All responses were converted to a score of between 0 and 100 using a linear transformation following EORTC guidelines (EORTC). High scores indicate good functioning but a high level of symptoms

    Time frame: 3 months

  7. FEV1 s

    Forced performed in a standardised manner

    Time frame: 3 months

  8. PEF (Peak Expiratory Flow)

    Peak Expiratory Flow performed in a standardised manner

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02335970
Responsible party
Sponsor
First posted
Jan 12, 2015
Start date
Sep 5, 2005
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Jan 6, 2020

Study contacts

Monika Fagevik Olsén, PhD
principal investigator · Professor at Sahlgrenska Academy at Gothenburg University, Sweden

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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