Fitness, Activity and Lung Cancer Study

Lung Cancer Clinical Trial

— FALC  

Official title:

Cardiorespiratory Fitness and Effect of Training After Lung Cancer Surgery. A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748981
• Other study ID #: FALC-2010-OUSNIH
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Est. completion date: June 20, 2018

Study information

• Verified date: February 2019
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: June 20, 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

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, not training

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian School of Sport Sciences, University Hospital, Akershus, Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Edvardsen E, Skjønsberg 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	DXA scan	Change in body composition from before to after surgery and after the intervention	An expected average of two weeks before surgery, four to six weeks after surgery, after six months and after five years
Other	Quality of life	Change in quality of life from before to after surgery and after the intervention	Measured three times: An expected average of two weeks before surgery, four to six weeks after surgery, after six months and after five years
Other	Physical activity	Physical activity will be objectively measured by accelerometers for seven consecutive days to determine change in activity level after surgery	Measured three times: six weeks after surgery, after six months and after five years
Primary	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	An expected average of two weeks before surgery (baseline), four to six weeks after surgery, after six months and after 5 years
Secondary	Change in Pulmonary function from baseline	Change in pulmonary function from before to after surgery and after the intervention	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.

External Links

•   Reduction in cardiorespiratory fitness after lung resection is not related to the number of lung segments removed