Clinical trial NCT01748981: Fitness, Activity and Lung Cancer Study
Official title: Cardiorespiratory Fitness and Effect of Training After Lung Cancer Surgery. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Pulmonary function
Maximal oxygen uptake
Cardiorespiratory fitness
High-intensity training
Surgery
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian School of Sport Sciences
name: University Hospital, Akershus
name: Vestre Viken Hospital Trust
First posted: 2012-12-13
Enrollment: 71
Sex: ALL
Minimum age (years): 30
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change in Maximal oxygen uptake (VO2max) from baseline
timeFrame: An expected average of two weeks before surgery (baseline), four to six weeks after surgery, after six months and after 5 years
Secondary outcomes:
measure: Change in Pulmonary function from baseline
timeFrame: 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 outcomes:
measure: DXA scan
timeFrame: An expected average of two weeks before surgery, four to six weeks after surgery, after six months and after five years
measure: Quality of life
timeFrame: Measured three times: An expected average of two weeks before surgery, four to six weeks after surgery, after six months and after five years
measure: Physical activity
timeFrame: Measured three times: six weeks after surgery, after six months and after five years
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Elisabeth Edvardsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.