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The Effect of Post-thoracotomy Pulmonary Rehabilitation on Quality of Life

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00460668
First Posted: April 16, 2007
Last Update Posted: April 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jan W.K. van den Berg, Isala Klinieken
  Purpose
The purpose of this study is to evaluate the effects of an integrated multidisciplinary rehabilitation program on health related quality of life in the 12 months postoperative period in patients with an elective thoracotomy and to evaluate the effects of the program on general quality of life (SF-36), acute/chronic post-thoracotomy pain, impairment (changes in pulmonary function), disability (exercise capacity) and start to complete recovery (ECOG score of 0 or 1) 12 months postoperatively in patients with an elective thoracotomy.

Condition Intervention
Lung Cancer Thoracotomy Pulmonary Rehabilitation Behavioral: pulmonary rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Prospective Single Centre Open Randomized Trial on the Effect of Post-thoracotomy Pulmonary Rehabilitation on Quality of Life

Resource links provided by NLM:


Further study details as provided by Jan W.K. van den Berg, Isala Klinieken:

Primary Outcome Measures:
  • SGRQ total score [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • SF-36 scores [ Time Frame: 12 months ]
  • McGill pain questionnaire scores [ Time Frame: 12 months ]
  • Pulmonary function and 6MWD [ Time Frame: 3 months ]

Enrollment: 57
Study Start Date: April 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pulmonary rehabilitation post-thoracotomy
Pulmonary rehabilitation post-thoracotomy
Behavioral: pulmonary rehabilitation
2 or 3 times a week during 8 weeks
No Intervention: Control
Control

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective, thoracotomy patients with a surgical intention to cure.
  • age between 18 and 80 years.
  • ECOG 0 - 2 post-thoracotomy.

Exclusion Criteria:

  • patients with chronic pain.
  • a previous thoracotomy.
  • comorbidity limiting rehabilitation.
  • non-compliance
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00460668


Locations
Netherlands
Isala Klinieken
Zwolle, Netherlands, 8011 JW
Sponsors and Collaborators
Isala
Investigators
Study Director: J.A. Stigt Isala
  More Information

Responsible Party: Jan W.K. van den Berg, Dr., Isala Klinieken
ClinicalTrials.gov Identifier: NCT00460668     History of Changes
Other Study ID Numbers: NL14089.075.06
First Submitted: April 13, 2007
First Posted: April 16, 2007
Last Update Posted: April 8, 2013
Last Verified: April 2013

Keywords provided by Jan W.K. van den Berg, Isala Klinieken:
elective thoracotomy
pulmonary rehabilitation
quality of life