Move For Surgery - A Novel Preconditioning Program

NCT ID: NCT03689634

Last Updated: 2023-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2022-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer, Nonsmall Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Move For Surgery Preconditioning Program Intervention Group

Group Type EXPERIMENTAL

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

Intervention Type 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.

Standard Preoperative Care Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamilton Academic Health Sciences Organization

OTHER

Sponsor Role collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role lead

Responsible Party

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Wael Hanna

Associate Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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Patel YS, Sullivan KA, Churchill IF, Beauchamp MK, Wald J, Mbuagbaw L, Fahim C, Hanna WC. Preconditioning program reduces the incidence of prolonged hospital stay after lung cancer surgery: Results from the Move For Surgery randomized clinical trial. Br J Surg. 2023 Oct 10;110(11):1467-1472. doi: 10.1093/bjs/znad252.

Reference Type DERIVED
PMID: 37643916 (View on PubMed)

Other Identifiers

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SJHH-MFS-RCT

Identifier Type: -

Identifier Source: org_study_id

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