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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jan W.K. van den Berg, Isala Klinieken
ClinicalTrials.gov Identifier:
NCT00460668
First received: April 13, 2007
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Isala Klinieken:

Primary Outcome Measures:
  • SGRQ total score [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF-36 scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • McGill pain questionnaire scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Pulmonary function and 6MWD [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460668

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

No publications provided

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
Study First Received: April 13, 2007
Last Updated: April 5, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Isala Klinieken:
elective thoracotomy
pulmonary rehabilitation
quality of life

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013