Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery

• Sponsor: Göteborg University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02335970
• Collaborator: Karolinska University Hospital (Other)
• Enrollment: 64
• Arms: 2
• Actual Duration (Months): 68.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oesophagus Cancer	Other: Training group	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery -a Randomized Controlled Trial
• Actual Study Start Date: Sep 5, 2005
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Training group Training program: Daily exercises for 3 months	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
No Intervention: Controls Standard care

Outcome Measures

Primary Outcome Measures

1. 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

1. Pain in the neck, rib cage and shoulders (visual analogue scale) [3 months]

   Estimated on a 100-mm visual analogue scale

2. FVC (Forced Vital Capacity) [3 months]

   Forced Vital Capacity performed in a standardised manner

3. Range of motion [3 months]

   Thorax expansion, back flexion, extension and lateral flexion, shoulder flexion and abduction

4. Physical function (Time stand test and heel rise test) [3 months]

   Time stand test and heel rise test

5. 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

6. 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

7. FEV1 s [3 months]

   Forced performed in a standardised manner

8. PEF (Peak Expiratory Flow) [3 months]

   Peak Expiratory Flow performed in a standardised manner

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Göteborg University
• Karolinska University Hospital

Investigators

• Principal Investigator: Monika Fagevik Olsén, PhD, Professor at Sahlgrenska Academy at Gothenburg University, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Göteborg University
• ClinicalTrials.gov Identifier: NCT02335970
• Other Study ID Numbers: FoU in Sweden 13891
• First Posted: Jan 12, 2015
• Last Update Posted: Jan 6, 2020
• Last Verified: Jan 1, 2020

• Keywords provided by Göteborg University: Pain; Range of motion; Quality of life
• Additional relevant MeSH terms: Esophageal Neoplasms

Study Results

No Results Posted as of Jan 6, 2020