Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery

NCT ID: NCT02335970

Last Updated: 2020-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-05
• Study Completion Date: 2011-06-30

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.

Conditions

Oesophagus Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Training group

Training program: Daily exercises for 3 months

Group Type: EXPERIMENTAL

Training group

Intervention Type: OTHER

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

Controls

Standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monika Fagevik Olsén, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor at Sahlgrenska Academy at Gothenburg University, Sweden

Other Identifiers

FoU in Sweden 13891

Identifier Type: -

Identifier Source: org_study_id