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Clinical Trials/NCT02335970
NCT02335970
Completed
N/A

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

Göteborg University0 sites64 target enrollmentSeptember 5, 2005

Overview

Phase
N/A
Intervention
Not specified
Conditions
Oesophagus Cancer
Sponsor
Göteborg University
Enrollment
64
Primary Endpoint
Degree of physical disability estimated by the Disability Rating Index (DRI)
Status
Completed
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
September 5, 2005
End Date
June 2011
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Göteborg University
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • FVC (Forced Vital Capacity)(3 months)
  • Pain in the neck, rib cage and shoulders (visual analogue scale)(3 months)
  • Range of motion(3 months)
  • Physical function (Time stand test and heel rise test)(3 months)
  • Physical Activity (six-level scale)(3 months)
  • Quality of Life by EORTC QLQ-C30(3 months)
  • PEF (Peak Expiratory Flow)(3 months)
  • FEV1 s(3 months)

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