Predictive Properties of the 6-Minute Stepper Test for Mortality in COPD

NCT06703359 | Recruiting

• 1 other identifier: SixSTeM-COPD
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Retrospective study aimed to answer the following research questions :

• What are the predictive properties of the 6-minute stepper in COPD for 2-year mortality in individuals with COPD ?
• What are the predictive properties of the 6-minute stepper in COPD for 5-year mortality in invididuals with COPD ?

Conditions

COPD

Keywords

COPD; Six-minute stepper test; Pulmonary rehabilitation; Exercise testing

Outcome Measures

Primary Outcomes (2)

• Two-year mortality

  Vital status (alive or deceased) will be collected from the database of the French National Institute of Statistics and Economic Studies (INSEE): https://arbre.app/insee.

  From the 6-Minute Stepper Test to two years thereafter

• Five-year mortality

  Vital status (alive or deceased) will be collected from the database of the French National Institute of Statistics and Economic Studies (INSEE): https://arbre.app/insee.

  From the 6-Minute Stepper Test to five years thereafter

Study Arms (1)

COPD referred for pulmonary rehabilitation.

Included participant were referred for pulmonary. During their baseline assessment, they performed the 6-Minute Stepper Test and were then followed for 5 years.

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

People with COPD referred for pulmonary rehabilitation.

You may qualify if:

• Age \> 18 years;
• Covered by a social security scheme;
• COPD (all stages);
• Referred for pulmonary rehabilitation;
• Completed a 6-Minute Stepper Test at the start of their program.
• Patients under guardianship or legal supervision;
• Pregnant or breastfeeding women.

You may not qualify if:

• Not applicable.

Sponsors & Collaborators

• ADIR Association: lead

Study Sites (1)

ADIR Association

Rouen, 76000, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tristan Bonnevie, PhD

  ADIR Association

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tristan Bonnevie, PhD

CONTACT

+33232592970; t.bonnevie@adir-hautenormandie.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 25, 2024
• Study Start: June 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2029
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available after publication.
• Access Criteria: Data will be made available upon request to t.bonnevie@adir-hautenormandie.com

Locations

FR (1)