Skip to main content
OpenTrials
Completed

NCT Number: NCT02335970

Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Oesophagus Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training group

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

Primary outcomes

  1. 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

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

    Time frame: 3 months

    Estimated on a 100-mm visual analogue scale

  2. FVC (Forced Vital Capacity)

    Time frame: 3 months

    Forced Vital Capacity performed in a standardised manner

  3. Range of motion

    Time frame: 3 months

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

  4. Physical function (Time stand test and heel rise test)

    Time frame: 3 months

    Time stand test and heel rise test

  5. Physical Activity (six-level scale)

    Time frame: 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

    Time frame: 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

    Time frame: 3 months

    Forced performed in a standardised manner

  8. PEF (Peak Expiratory Flow)

    Time frame: 3 months

    Peak Expiratory Flow performed in a standardised manner

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Karolinska University Hospital

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Jan 12, 2015
Registry last updated
Jan 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.