Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery

Not Applicable

Completed

• Conditions: Oesophagus Cancer
• Interventions: Other: Training group

• Registration Number: NCT02335970
• Lead Sponsor: Göteborg University

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.

Study Timeline

• Study Start: 2005-09-05
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted: 2014-12-30
• Study First Submitted QC: 2015-01-09
• Study First Posted: 2015-01-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-03
• Last Update Posted: 2020-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Training group	Training group	Training program: Daily exercises for 3 months

Primary Outcome Measures

Name	Time	Method
Degree of physical disability estimated by the Disability Rating Index (DRI)	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)

Secondary Outcome Measures

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