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Fitness, Activity and Lung Cancer Study (FALC)

This study is enrolling participants by invitation only.
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: June 16, 2016
Last verified: June 2016
  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, muscular strength, morbidity and survival. Physical activity level by accelerometers, body composition by DXA and quality of life 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:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Change in Maximal oxygen uptake (VO2max) from baseline [ Time Frame: An expected average of two weeks before surgery (baseline), four to six weeks after surgery, after six months and after 5 years ] [ Designated as safety issue: Yes ]
    Change in VO2max from before to after surgery to measure the effect of surgery, and after six months to measure the effect of high-intensity training intervention, and after five years to study long-term effects


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, after after six months and after five years. ] [ 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, after six months and after five years ] [ Designated as safety issue: No ]
    Change in body composition from before to after surgery and after the intervention

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

  • Physical activity [ Time Frame: Measured three times: six weeks after surgery, after six months and after five years ] [ Designated as safety issue: No ]
    Physical activity will be objectively 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 2018
Estimated Primary Completion Date: December 2017 (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

Detailed Description:
Five year after surgery, all included patients will be reinvited to undergo a fourth health excame to study the long-term effects of exercise training on physical fitness, morbidity and survival.
  Eligibility

Ages Eligible for Study:   30 Years to 79 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, PhD Oslo University Hospital
  More Information

Additional Information:
Publications:
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: June 16, 2016
Health Authority: Norway: Regional Ethics Commitee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Oslo University Hospital:
Pulmonary function
Maximal oxygen uptake
Cardiorespiratory fitness
High-intensity training
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 September 30, 2016