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

Lung Neoplasm Malignant Clinical Trial

— PREOTEST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824977
• Other study ID #: 2018-A02694-51
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

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

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