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Fitness, Activity and Lung Cancer Study (FALC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Norwegian School of Sport Sciences
University Hospital, Akershus
Vestre Viken Hospital Trust
Information provided by (Responsible Party):
Elisabeth Edvardsen, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01748981
First received: August 8, 2011
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

The purpose of the study is to investigate the change in pulmonary function and exercise capacity in lung cancer patients after pulmonary resection. Furthermore, to study the effect of training on aerobic capacity and muscular strength. Physical activity level by accelerometers, body composition by DXA and quality of life by questionaire will also be reported.


Condition Intervention
Lung Cancer
 Other: Physical training
Other: As usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: Cardiorespiratory Fitness and Effect of Training After Lung Cancer Surgery. A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Change in Maximal oxygen uptake (VO2max) from baseline [ Time Frame: An expexted average of two weeks before surgery (baseline), four to six weeks after surgery and after six months ] [ Designated as safety issue: Yes ]
    Change in VO2max from before to after surgery to measure the effect of surgery, and after six months after surgery to measure the effect of trainingintervention


Secondary Outcome Measures:
  • Change in Pulmonary function from baseline [ Time Frame: Pulmonary function is measured three times; an expected average of two weeks before surgery, four to six weeks after surgery and after six months. ] [ Designated as safety issue: Yes ]
    Change in pulmonary function from before to after surgery and after the intervention


Other Outcome Measures:
  • DXA scan [ Time Frame: An expected average of two weeks before surgery, four to six weeks after surgery and after 6 mnd ] [ Designated as safety issue: No ]
    Change in body composition from before to after surgery and after the intervention

  • Questionnaire on Quality of life [ Time Frame: Measured three times: An expected average of two weeks before surgery, four to six weeks after surgery and after six months ] [ Designated as safety issue: No ]
    Change in quality of life from before to after surgery and after the intervention

  • Measurement of physical activity [ Time Frame: Measured two times: six weeks after the surgery and after 6 months ] [ Designated as safety issue: No ]
    Physical activity will be measured by accelerometers for seven consecutive days to determine change in activity level after surgery


Estimated Enrollment: 80
Study Start Date: November 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Physical training
Exercise intervention.
 Other: Physical training
Physical training three times a week for 20 week including endurance and strength training compare to the "as usual" group as controls
As usual
Controls
 Other: As usual
Controls, not training

  Eligibility

Ages Eligible for Study:   30 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non smal cell lung cancer
  • Patient living in Oslo or Akershus county and accepted for lung cancer surgery at Oslo University hospital and Akershus University hospital
  • were able to read and speak Norwegian

Exclusion Criteria:

  • Mental incompetence or physical disability that makes it difficult to walk on a treadmill
  • Treatment or medical complications affecting ability to participate in an exercise group
  • > 79 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748981

Locations
Norway
Oslo University Hospital
Oslo, Norway, 0450
Sponsors and Collaborators
Oslo University Hospital
Norwegian School of Sport Sciences
University Hospital, Akershus
Vestre Viken Hospital Trust
Investigators
Principal Investigator: Elisabeth Edvardsen, Cand Scient Oslo University Hospital
  More Information

No publications provided

Responsible Party: Elisabeth Edvardsen, Prinsipal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01748981     History of Changes
Other Study ID Numbers: FALC-2010-OUSNIH
Study First Received: August 8, 2011
Last Updated: December 12, 2012
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Oslo University Hospital:
Pulmonary function
Maximal oxygen uptake
Cardiorespiratory fitness
Exercise
Surgery

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 19, 2013