Prognostic Value of the 6-minute Stepper Test in Non-small Cell Lung Cancer Surgery

The objective of this study is to evaluate the performances of the Six-Minute Stepper Test (6MST) and Sit To Stand test (STST) to predict post-operative complications after minimally invasive lung cancer resection.

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Key information

Conditions

Lung Neoplasm Malignant Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Resectable Lung Non-Small Cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boujibar , F

Rouen, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age >18
Non-small cell lung cancer stage I to II, justifying major resection by VATS or RATS (segmentectomy, lobectomy, pneumonectomy), with or without histological confirmation

Exclusion criteria

Partial or total amputation localized to the lower limb;
Weight greater than 100 kg;
Orthopedic, vascular or neurological disorders leading to the incapacity of realize the 6MST;
Patient under tutorship or curatorship;
Pregnant woman.
Surgery canceled

Treatment and study plan

Six minutes stepper test (6MST)

Diagnostic Test

The 6MST is done using a stepper (Stepper essential, Decathlon(TM), France), with a walking height of 20 cm, placed in front of a wall or parallel bars, so patients can hold on if necessary.

Patients are instructed to make the maximum number of steps possible in 6 minutes, and are given a time check at one minute intervals.

Sit to stand test (STST)

Diagnostic Test

The STST is done using a chair measuring 47 cm in height. The patient are instructed to sit in the chair and then to do the maximum number of lifts possible from the chair, in 1 minute, with arms folded and without leaning against the chair.

Primary outcomes

occurrence of a post-operative complication grade ≥ 2 on the Clavien-Dindo scale within three months after surgery

Time frame: 90 days

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: PREOTEST

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Jan 31, 2019
Registry last updated: Mar 7, 2022

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.

Published trials that share one or more normalized conditions with this study.

Completed