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

NCT03824977 | Completed DMC

• 1 other identifier: 2018-A02694-51
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Neoplasm Malignant; Resectable Lung Non-Small Cell Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  90 days

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Boujibar , F

Rouen, France

Location

Related Publications (1)

• 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.

  PMID: 35396177 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 31, 2019
• Study Start: November 21, 2018
• Primary Completion: February 4, 2020
• Study Completion: February 4, 2020
• Last Updated: March 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)