Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery
Primary Purpose
Oesophagus Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Training group
Sponsored by
About this trial
This is an interventional treatment trial for Oesophagus Cancer focused on measuring Pain, Range of motion, Quality of life
Eligibility Criteria
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:
- Serious untreated cardiac disease that may be critical
- Musculoskeletal or neurological disease or trauma affecting respiration or range of motion in the rib cage
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Training group
Controls
Arm Description
Training program: Daily exercises for 3 months
Standard care
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Pain in the neck, rib cage and shoulders (visual analogue scale)
Estimated on a 100-mm visual analogue scale
FVC (Forced Vital Capacity)
Forced Vital Capacity performed in a standardised manner
Range of motion
Thorax expansion, back flexion, extension and lateral flexion, shoulder flexion and abduction
Physical function (Time stand test and heel rise test)
Time stand test and heel rise test
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
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
FEV1 s
Forced performed in a standardised manner
PEF (Peak Expiratory Flow)
Peak Expiratory Flow performed in a standardised manner
Full Information
NCT ID
NCT02335970
First Posted
December 30, 2014
Last Updated
January 3, 2020
Sponsor
Göteborg University
Collaborators
Karolinska University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02335970
Brief Title
Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery
Official Title
Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery -a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 5, 2005 (Actual)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Karolinska University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oesophagus Cancer
Keywords
Pain, Range of motion, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training group
Arm Type
Experimental
Arm Description
Training program: Daily exercises for 3 months
Arm Title
Controls
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Other
Intervention Name(s)
Training group
Intervention Description
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
Primary Outcome Measure Information:
Title
Degree of physical disability estimated by the Disability Rating Index (DRI)
Description
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 Outcome Measure Information:
Title
Pain in the neck, rib cage and shoulders (visual analogue scale)
Description
Estimated on a 100-mm visual analogue scale
Time Frame
3 months
Title
FVC (Forced Vital Capacity)
Description
Forced Vital Capacity performed in a standardised manner
Time Frame
3 months
Title
Range of motion
Description
Thorax expansion, back flexion, extension and lateral flexion, shoulder flexion and abduction
Time Frame
3 months
Title
Physical function (Time stand test and heel rise test)
Description
Time stand test and heel rise test
Time Frame
3 months
Title
Physical Activity (six-level scale)
Description
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
Title
Quality of Life by EORTC QLQ-C30
Description
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
Title
FEV1 s
Description
Forced performed in a standardised manner
Time Frame
3 months
Title
PEF (Peak Expiratory Flow)
Description
Peak Expiratory Flow performed in a standardised manner
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Serious untreated cardiac disease that may be critical
Musculoskeletal or neurological disease or trauma affecting respiration or range of motion in the rib cage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monika Fagevik Olsén, PhD
Organizational Affiliation
Professor at Sahlgrenska Academy at Gothenburg University, Sweden
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery
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