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Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery

Primary Purpose

Oesophagus Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Training group
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oesophagus Cancer focused on measuring Pain, Range of motion, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Training group

    Controls

    Arm Description

    Training program: Daily exercises for 3 months

    Standard care

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

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

    Full Information

    First Posted
    December 30, 2014
    Last Updated
    January 3, 2020
    Sponsor
    Göteborg University
    Collaborators
    Karolinska University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02335970
    Brief Title
    Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery
    Official Title
    Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery -a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 5, 2005 (Actual)
    Primary Completion Date
    June 2011 (Actual)
    Study Completion Date
    June 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Göteborg University
    Collaborators
    Karolinska University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oesophagus Cancer
    Keywords
    Pain, Range of motion, Quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    64 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Training group
    Arm Type
    Experimental
    Arm Description
    Training program: Daily exercises for 3 months
    Arm Title
    Controls
    Arm Type
    No Intervention
    Arm Description
    Standard care
    Intervention Type
    Other
    Intervention Name(s)
    Training group
    Intervention Description
    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 Outcome Measure Information:
    Title
    Degree of physical disability estimated by the Disability Rating Index (DRI)
    Description
    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)
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Pain in the neck, rib cage and shoulders (visual analogue scale)
    Description
    Estimated on a 100-mm visual analogue scale
    Time Frame
    3 months
    Title
    FVC (Forced Vital Capacity)
    Description
    Forced Vital Capacity performed in a standardised manner
    Time Frame
    3 months
    Title
    Range of motion
    Description
    Thorax expansion, back flexion, extension and lateral flexion, shoulder flexion and abduction
    Time Frame
    3 months
    Title
    Physical function (Time stand test and heel rise test)
    Description
    Time stand test and heel rise test
    Time Frame
    3 months
    Title
    Physical Activity (six-level scale)
    Description
    A six-level scale where low figures indicate a sedentary and a high score an active lifestyle according to Grimby et al
    Time Frame
    3 months
    Title
    Quality of Life by EORTC QLQ-C30
    Description
    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
    Time Frame
    3 months
    Title
    FEV1 s
    Description
    Forced performed in a standardised manner
    Time Frame
    3 months
    Title
    PEF (Peak Expiratory Flow)
    Description
    Peak Expiratory Flow performed in a standardised manner
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Monika Fagevik Olsén, PhD
    Organizational Affiliation
    Professor at Sahlgrenska Academy at Gothenburg University, Sweden
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery

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