Oesophagus CancerNCT02335970
Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery
A study testing Training group in people with Oesophagus Cancer, run by Göteborg University.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oesophagus Cancer
- What is being tested?
- Training group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2005to Jun 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for thoracoabdominal oesophageal resection
- Ability to perform 90 W during a sub-maximal bicycle test
- Ability to speak Swedish
Who cannot join
- Serious untreated cardiac disease that may be critical
- Musculoskeletal or neurological disease or trauma affecting respiration or range of motion in the rib cage
About this study
Official title: Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery -a Randomized Controlled Trial
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.
- Conditions
- Oesophagus Cancer
- Being tested
- Training group
- Keywords
- Pain, Range of motion, Quality of life
- Medical subject headings
- Esophageal Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training groupOther
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
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | Training program: Daily exercises for 3 months Receives: Other: Training group |
| Controls | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Secondary outcomes (8)
Pain in the neck, rib cage and shoulders (visual analogue scale)
Estimated on a 100-mm visual analogue scale
Measured: 3 months
FVC (Forced Vital Capacity)
Forced Vital Capacity performed in a standardised manner
Measured: 3 months
Range of motion
Thorax expansion, back flexion, extension and lateral flexion, shoulder flexion and abduction
Measured: 3 months
Physical function (Time stand test and heel rise test)
Time stand test and heel rise test
Measured: 3 months
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
Measured: 3 months
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
Measured: 3 months
FEV1 s
Forced performed in a standardised manner
Measured: 3 months
PEF (Peak Expiratory Flow)
Peak Expiratory Flow performed in a standardised manner
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study start5 Sep 2005
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesophagus 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Sponsor
- Investigators
- Monika Fagevik Olsén, PhD, Principal investigator, Professor at Sahlgrenska Academy at Gothenburg University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335970
- Sponsor's protocol ID
- FoU in Sweden 13891
- Status last verified
- Jan 2020
- First submitted
- 30 Dec 2014
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery -a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02335970
- Acronym / sponsor ID
- FoU in Sweden 13891
- Conditions
- Oesophagus Cancer
- Keywords
- Pain, Range of motion, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- 5 Sep 2005 (actual)
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 12 Jan 2015 (estimated)
- 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Other: Training groupTraining program: Daily exercises for 3 months |
| Controls | No intervention | –Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for thoracoabdominal oesophageal resection
- Ability to perform 90 W during a sub-maximal bicycle test
- Ability to speak Swedish
Key exclusion criteria (2 listed)
- Serious untreated cardiac disease that may be critical
- Musculoskeletal or neurological disease or trauma affecting respiration or range of motion in the rib cage
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 |
|---|---|---|
| Training groupAfter 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 | Other | Training group |
Primary outcome
Degree of physical disability estimated by the Disability Rating Index (DRI)
Time frame: 3 months
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)
8 secondary outcomes
Pain in the neck, rib cage and shoulders (visual analogue scale)
Time frame: 3 months
FVC (Forced Vital Capacity)
Time frame: 3 months
Range of motion
Time frame: 3 months
Physical function (Time stand test and heel rise test)
Time frame: 3 months
Physical Activity (six-level scale)
Time frame: 3 months
Quality of Life by EORTC QLQ-C30
Time frame: 3 months
FEV1 s
Time frame: 3 months
PEF (Peak Expiratory Flow)
Time frame: 3 months
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 6 Jan 2020.
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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
Professor at Sahlgrenska Academy at Gothenburg University, Sweden
Questions about this trial
What is this clinical trial studying?
A study testing Training group in people with Oesophagus Cancer, run by Göteborg University.
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 3 inclusion and 2 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 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Degree of physical disability estimated by the Disability Rating Index (DRI) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2020.