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Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02335970
Enrollment
64
Registered
2015-01-12
Start date
2005-09-05
Completion date
2011-06-30
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oesophagus Cancer

Keywords

Pain, Range of motion, Quality of life

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.

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

Sponsors

Karolinska University Hospital
CollaboratorOTHER
Göteborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Degree of physical disability estimated by the Disability Rating Index (DRI)3 months12 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

MeasureTime frameDescription
FVC (Forced Vital Capacity)3 monthsForced Vital Capacity performed in a standardised manner
Range of motion3 monthsThorax expansion, back flexion, extension and lateral flexion, shoulder flexion and abduction
Physical function (Time stand test and heel rise test)3 monthsTime stand test and heel rise test
Pain in the neck, rib cage and shoulders (visual analogue scale)3 monthsEstimated on a 100-mm visual analogue scale
Quality of Life by EORTC QLQ-C303 monthsEuropean 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 s3 monthsForced performed in a standardised manner
PEF (Peak Expiratory Flow)3 monthsPeak Expiratory Flow performed in a standardised manner
Physical Activity (six-level scale)3 monthsA six-level scale where low figures indicate a sedentary and a high score an active lifestyle according to Grimby et al

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026