Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery

Oesophagus Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335970
• Other study ID #: FoU in Sweden 13891
• Status: Completed
• Phase: N/A
• Start date: September 5, 2005
• Est. completion date: June 2011

Study information

• Verified date: January 2020
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Oesophagus Cancer

Intervention

Other:
• Training 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Karolinska University Hospital

Outcome

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