Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery

Study Overview
=================
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.

Official Title
-----------------
Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery -a Randomized Controlled Trial

Conditions
-----------------
Oesophagus Cancer

Intervention / Treatment
-----------------
* Other: Training group


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training group<br>Training program: Daily exercises for 3 months | Other: Training group<br>* 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<br>|
| No Intervention: Controls<br>Standard care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain in the neck, rib cage and shoulders (visual analogue scale) | Estimated on a 100-mm visual analogue scale | 3 months | 
| FVC (Forced Vital Capacity) | Forced Vital Capacity performed in a standardised manner | 3 months | 
| Range of motion | Thorax expansion, back flexion, extension and lateral flexion, shoulder flexion and abduction | 3 months | 
| Physical function (Time stand test and heel rise test) | Time stand test and heel rise test | 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 | 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 | 3 months | 
| FEV1 s | Forced performed in a standardised manner | 3 months | 
| PEF (Peak Expiratory Flow) | Peak Expiratory Flow performed in a standardised manner | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Range of motion, Quality of life