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CompletedNCT03824977PREOTESTUpdated Mar 7, 2022

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

An observational study in Lung Neoplasm Malignant and Resectable Lung Non-Small Cell Carcinoma, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-07.

Sponsored by University Hospital, Rouen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
122
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Lung Neoplasm Malignant
  • Resectable Lung Non-Small Cell Carcinoma

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Keywords

  • lung resection
  • low technology
  • six minutes stepper test
  • sit to stand test
  • physiotherapy
  • lung surgery
  • post-operative complications
03

In context

Lung Neoplasms

7,334 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.

This study's enrollment of 122 is below the median of 190 across 1,547 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

University Hospital, Rouen is the lead sponsor of 417 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Consecutive patients are included. On the day of the surgical consultation, the patient is informed of the modalities of the study by the thoracic surgeon and collects his non-opposition of participation. He is also evaluated by a physiotherapist, who supervises the realization of 6MST and STST.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
122 participants (actual)
Target follow-up
4 Months
Patient registry
Yes

Interventions

  • Diagnostic testSix 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.

  • Diagnostic testSit 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.

06

What researchers measure

Primary outcomes

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

    Time frame: 90 days

07

Study locations

1 site
  • Boujibar , F
    Rouen, France
08

References and documents

Publications

  • 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. PubMed 35396177 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2018 to primary completion in Feb 2020, 14 months.

Of 578 non-industry observational studies under Lung Neoplasms, half reached primary completion within 68 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 172. This study's 14 months is below that.

Counting every sponsor, half of 685 studies reached it within 56 months; a quarter within 29 and three quarters within 130.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 29, 2019
First posted
Jan 31, 2019
StartActual
Nov 21, 2018
Primary completionActual
Feb 4, 2020
CompletionActual
Feb 4, 2020
Last update
Mar 7, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03824977
Responsible party
Sponsor
First posted
Jan 31, 2019
Start date
Nov 21, 2018
Primary completion
Feb 4, 2020
Completion
Feb 4, 2020
Last update
Mar 7, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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