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OpenTrials
Completed

NCT Number: NCT03689634

Move For Surgery - A Novel Preconditioning Program

Lung cancer is the leading cause of cancer death in Canada. Most patients with this cancer will undergo treatment with major chest surgery that is associated with serious complications. As many as 50% of patients will suffer respiratory complications after surgery, keeping them in the hospital for extended periods of time. These long hospitalizations have a dramatic negative effect on the lives of those people, in addition to a large cost burden on our healthcare system. Traditionally, patients who suffer from complications are treated with rehabilitation AFTER the complications have occurred. But what if complications can be prevented BEFORE they happen? Having major chest surgery imposes great stress on the human body, one that is equivalent to running a marathon. Analogous to training before completing a marathon, the investigator designed Move For Surgery (MFS), a novel preconditioning program that encourages and empowers patients to improve their health prior to surgery. The investigator aims to demonstrate that patients who train with Move For Surgery will have lower respiratory complication rates, will recover better, and will leave the hospital sooner than their counterparts.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Clinical stage I, II, or IIIa non-small cell lung cancer (NSCLC)
  • Candidates for thoracic surgery, as determined by the operating surgeon

Exclusion criteria

  • Clinical stage IIIb or IV NSCLC
  • Patients with affected mobility (wheelchair, walker)
  • Patients who use oxygen at home

Treatment and study plan

Move For Surgery Preconditioning Program using a Wearable Activity Tracker (Fitbit) Intervention Group

Device

Participants randomized to this group will be be provided with a wearable activity tracker (Fitbit) for the duration of the study and asked to reach daily step goals.

Primary outcomes

  1. The primary outcome of the comparative trial will be length of stay (LOS) in hospital after surgery, which will also be used to measure speed of recovery from surgery and postoperative complications.

    Time frame: 24 months

    LOS is a good surrogate measure for the speed of recovery from surgery (patients who recover faster leave hospital earlier) and postoperative complications (patients who do not suffer complications leave the hospital earlier).

Secondary outcomes

  1. Secondary outcome will include differences in the 36-Item Short Form Health Survey (SF-36) scores before and after the intervention.

    Time frame: 24 months

    The quality of life as reported by patients will be compared.

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Collaborators

  • Hamilton Academic Health Sciences Organization

Registry information

Official study title

Move For Surgery - A Novel Preconditioning Program to Optimize Health Before Thoracic Surgery: A Randomized Controlled Trial

Acronym: MFS

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Sep 28, 2018
Registry last updated
Jul 3, 2023

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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