Lung CancerFALCNCT01748981
Fitness, Activity and Lung Cancer Study
A study testing Physical training and As usual in people with Lung Cancer, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Physical training and As usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2010to 20 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Physical training, As usual
- Keywords
- Pulmonary function, Maximal oxygen uptake, Cardiorespiratory fitness, High-intensity training, Surgery
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical trainingOther
Physical training three times a week for 20 week including endurance and strength training compare to the "as usual" group as controls
As usualOther
Controls, not training
| Study group | Role | What they receive |
|---|---|---|
| Physical training | Other | Exercise intervention. Receives: Other: Physical training |
| As usual | Other | Controls Receives: Other: As usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: An expected average of two weeks before surgery (baseline), four to six weeks after surgery, after six months and after 5 years
Secondary outcomes (1)
Change in Pulmonary function from baseline
Change in pulmonary function from before to after surgery and after the intervention
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startNov 2010
- Primary completionDec 2017
- Study completion20 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian School of Sport Sciences, University Hospital, Akershus, Vestre Viken Hospital Trust
- Responsible party
- Principal investigator, Elisabeth Edvardsen, Oslo University Hospital
- Investigators
- Elisabeth Edvardsen, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748981
- Sponsor's protocol ID
- FALC-2010-OUSNIH
- Acronym
- FALC
- Status last verified
- Feb 2019
- First submitted
- 8 Aug 2011
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 25323620Edvardsen 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.
PubMed 27900127
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiorespiratory Fitness and Effect of Training After Lung Cancer Surgery. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01748981
- Acronym / sponsor ID
- FALC / FALC-2010-OUSNIH
- Conditions
- Lung Cancer
- Keywords
- Pulmonary function, Maximal oxygen uptake, Cardiorespiratory fitness, High-intensity training, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian School of Sport Sciences, University Hospital, Akershus, Vestre Viken Hospital Trust
- Study start
- Nov 2010 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical training | Other | Other: Physical trainingExercise intervention. |
| As usual | Other | Other: As usualControls |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical trainingPhysical training three times a week for 20 week including endurance and strength training compare to the "as usual" group as controls | Other | Physical training |
| As usualControls, not training | Other | As usual |
Primary outcome
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
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Background: PubMed 25323620Edvardsen 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.
- Derived from this study: PubMed 27900127Edvardsen 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.
- Reduction in cardiorespiratory fitness after lung resection is not related to the number of lung segments removedLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Edvardsen, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical training and As usual in people with Lung Cancer, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01748981, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.