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Completed

NCT Number: NCT01748981

Fitness, Activity and Lung Cancer Study

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

30 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0450, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical training

Other

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

As usual

Other

Controls, not training

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

    Change in pulmonary function from before to after surgery and after the intervention

Other outcomes

  1. DXA scan

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

    Change in body composition from before to after surgery and after the intervention

  2. Quality of life

    Time frame: Measured three times: An expected average of two weeks before surgery, four to six weeks after surgery, after six months and after five years

    Change in quality of life from before to after surgery and after the intervention

  3. Physical activity

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

    Physical activity will be objectively measured by accelerometers for seven consecutive days to determine change in activity level after surgery

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Norwegian School of Sport Sciences
  • University Hospital, Akershus
  • Vestre Viken Hospital Trust

Registry information

Official study title

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

Acronym: FALC

Important dates

Study start
2010
Primary completion
2017
Study completion
2018
First posted
Dec 13, 2012
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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