Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery

NCT02335970 | Completed

• 1 other identifier: FoU in Sweden 13891
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oesophagus Cancer

Keywords

Pain; Range of motion; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

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

  3 months

• FVC (Forced Vital Capacity)

  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

Study Arms (2)

Training group

EXPERIMENTAL

Training program: Daily exercises for 3 months

Other: Training group

Controls

NO INTERVENTION

Standard care

Interventions

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

Training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for thoracoabdominal oesophageal resection
• Ability to perform 90 W during a sub-maximal bicycle test
• Ability to speak Swedish

You may not qualify if:

• Serious untreated cardiac disease that may be critical
• Musculoskeletal or neurological disease or trauma affecting respiration or range of motion in the rib cage

Sponsors & Collaborators

• Göteborg University: lead
• Karolinska University Hospital: collaborator

MeSH Terms

Conditions

Esophageal Neoplasms; Pain

Interventions

Sensitivity Training Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Psychotherapy, Group; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Monika Fagevik Olsén, PhD

  Professor at Sahlgrenska Academy at Gothenburg University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2014
• First Posted: January 12, 2015
• Study Start: September 5, 2005
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: January 6, 2020

Record last verified: 2020-01