Fitness, Activity and Lung Cancer Study (FALC)

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Physical training; Other: As usual

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.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0450
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: As usual; Controls	Other: As usual; Controls, not training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Vestre Viken Hospital Trust; University Hospital, Akershus; Norwegian School of Sport Sciences
• Investigators: Principal Investigator: Elisabeth Edvardsen, PhD, Oslo University Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2010
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): June 20, 2018

Study Registration Dates

• First Submitted: August 8, 2011
• First Submitted That Met QC Criteria: December 11, 2012
• First Posted (Estimate): December 13, 2012

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 9, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Surgery; Cardiorespiratory fitness; Pulmonary function; Maximal oxygen uptake; High-intensity training
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: FALC-2010-OUSNIH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO