Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Oesophagus Cancer
• Intervention / Treatment: Other: Training 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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain in the neck, rib cage and shoulders (visual analogue scale)	Estimated on a 100-mm visual analogue scale	3 months
FVC (Forced Vital Capacity)	Forced Vital Capacity performed in a standardised manner	3 months
Range of motion	Thorax expansion, back flexion, extension and lateral flexion, shoulder flexion and abduction	3 months
Physical function (Time stand test and heel rise test)	Time stand test and heel rise test	3 months
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	3 months
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	3 months
FEV1 s	Forced performed in a standardised manner	3 months
PEF (Peak Expiratory Flow)	Peak Expiratory Flow performed in a standardised manner	3 months

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Karolinska University Hospital
• Investigators: Principal Investigator: Monika Fagevik Olsén, PhD, Professor at Sahlgrenska Academy at Gothenburg University, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2005
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: December 30, 2014
• First Submitted That Met QC Criteria: January 9, 2015
• First Posted (Estimate): January 12, 2015

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: January 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Quality of life; Range of motion
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: FoU in Sweden 13891