Fitness, Activity and Lung Cancer Study (FALC)
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Physical training
As usual
Sponsored by
About this trial
This is an interventional health services research trial for Lung Cancer focused on measuring Pulmonary function, Maximal oxygen uptake, Cardiorespiratory fitness, High-intensity training, Surgery
Eligibility 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
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Physical training
As usual
Arm Description
Exercise intervention.
Controls
Outcomes
Primary Outcome Measures
Change in Maximal oxygen uptake (VO2max) from baseline
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
Change in pulmonary function from before to after surgery and after the intervention
Full Information
NCT ID
NCT01748981
First Posted
August 8, 2011
Last Updated
February 9, 2019
Sponsor
Oslo University Hospital
Collaborators
Norwegian School of Sport Sciences, University Hospital, Akershus, Vestre Viken Hospital Trust
1. Study Identification
Unique Protocol Identification Number
NCT01748981
Brief Title
Fitness, Activity and Lung Cancer Study
Acronym
FALC
Official Title
Cardiorespiratory Fitness and Effect of Training After Lung Cancer Surgery. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 2010 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
June 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Norwegian School of Sport Sciences, University Hospital, Akershus, Vestre Viken Hospital Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Pulmonary function, Maximal oxygen uptake, Cardiorespiratory fitness, High-intensity training, Surgery
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical training
Arm Type
Other
Arm Description
Exercise intervention.
Arm Title
As usual
Arm Type
Other
Arm Description
Controls
Intervention Type
Other
Intervention Name(s)
Physical training
Intervention Description
Physical training three times a week for 20 week including endurance and strength training compare to the "as usual" group as controls
Intervention Type
Other
Intervention Name(s)
As usual
Intervention Description
Controls, not training
Primary Outcome Measure Information:
Title
Change in Maximal oxygen uptake (VO2max) from baseline
Description
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
Time Frame
An expected average of two weeks before surgery (baseline), four to six weeks after surgery, after six months and after 5 years
Secondary Outcome Measure Information:
Title
Change in Pulmonary function from baseline
Description
Change in pulmonary function from before to after surgery and after the intervention
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.
Other Pre-specified Outcome Measures:
Title
DXA scan
Description
Change in body composition from before to after surgery and after the intervention
Time Frame
An expected average of two weeks before surgery, four to six weeks after surgery, after six months and after five years
Title
Quality of life
Description
Change in quality of life from before to after surgery and after the intervention
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
Title
Physical activity
Description
Physical activity will be objectively measured by accelerometers for seven consecutive days to determine change in activity level after surgery
Time Frame
Measured three times: six weeks after surgery, after six months and after five years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Edvardsen, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0450
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25323620
Citation
Edvardsen E, Skjonsberg OH, Holme I, Nordsletten L, Borchsenius F, Anderssen SA. High-intensity training following lung cancer surgery: a randomised controlled trial. Thorax. 2015 Mar;70(3):244-50. doi: 10.1136/thoraxjnl-2014-205944. Epub 2014 Oct 16.
Results Reference
background
PubMed Identifier
27900127
Citation
Edvardsen E, Anderssen SA, Borchsenius F, Skjonsberg OH. Reduction in cardiorespiratory fitness after lung resection is not related to the number of lung segments removed. BMJ Open Sport Exerc Med. 2015 Oct 5;1(1):e000032. doi: 10.1136/bmjsem-2015-000032. eCollection 2015.
Results Reference
derived
Links:
URL
http://bmjopensem.bmj.com/content/1/1/e000032.full.pdf+html
Description
Reduction in cardiorespiratory fitness after lung resection is not related to the number of lung segments removed
Learn more about this trial
Fitness, Activity and Lung Cancer Study
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