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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03824977
Other study ID # 2018-A02694-51
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 21, 2018
Est. completion date February 4, 2020

Study information

Verified date February 2022
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date February 4, 2020
Est. primary completion date February 4, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
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.
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.

Locations

Country Name City State
France Boujibar , F Rouen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary occurrence of a post-operative complication grade = 2 on the Clavien-Dindo scale within three months after surgery 90 days
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