NCT01748981

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2011

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

December 13, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2018

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

7.1 years

First QC Date

August 8, 2011

Last Update Submit

February 9, 2019

Conditions

Lung Cancer

Keywords

Pulmonary functionMaximal oxygen uptakeCardiorespiratory fitnessHigh-intensity trainingSurgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in Pulmonary function from baseline

    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 (3)

  • DXA scan

    An expected average of two weeks before surgery, four to six weeks after surgery, after six months and after five years

  • Quality of life

    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

    Measured three times: six weeks after surgery, after six months and after five years

Study Arms (2)

Physical training

OTHER

Exercise intervention.

Other: Physical training

As usual

OTHER

Controls

Other: As usual

Interventions

Physical trainingOTHER

Physical training three times a week for 20 week including endurance and strength training compare to the "as usual" group as controls

Physical training
As usualOTHER

Controls, not training

As usual

Eligibility Criteria

Age30 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0450, Norway

Location

Related Publications (2)

  • 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.

    PMID: 25323620BACKGROUND

  • 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.

    PMID: 27900127DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Elisabeth Edvardsen, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinsipal Investigator

Study Record Dates

First Submitted

August 8, 2011

First Posted

December 13, 2012

Study Start

November 1, 2010

Primary Completion

December 1, 2017

Study Completion

June 20, 2018

Last Updated

February 12, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)