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

NCT ID: NCT03824977

Last Updated: 2022-03-07

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-21

Study Completion Date

2020-02-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Neoplasm Malignant Resectable Lung Non-Small Cell Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Six minutes stepper test (6MST)

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.

Intervention Type DIAGNOSTIC_TEST

Sit to stand test (STST)

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boujibar , F

Rouen, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Boujibar F, Gillibert A, Bonnevie T, Rinieri P, Montagne F, Selim J, Cuvelier A, Gravier FE, Baste JM. The 6-minute stepper test and the sit-to-stand test predict complications after major pulmonary resection via minimally invasive surgery: a prospective inception cohort study. J Physiother. 2022 Apr;68(2):130-135. doi: 10.1016/j.jphys.2022.03.001. Epub 2022 Apr 5.

Reference Type DERIVED
PMID: 35396177 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-A02694-51

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Perioperative Treatment Outcomes of Early NSCLC
NCT06610240 ENROLLING_BY_INVITATION