The Six-minute Stepper Test as an Outcome Measure of Exercise Tolerance During Pulmonary Rehabilitation in With Chronic Obstructive Pulmonary Disease (COPD) Patients(STEPPER)?

Chronic Obstructive Pulmonary Disease Clinical Trial

— STEPPER  

Official title:

The Six-minute Stepper Test : Marker of Exercise Tolerance's Evolution During Pulmonary Rehabilitation in Patients With COPD ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01759199
• Other study ID #: RB 11-157 STEPPER
• Status: Completed
• Phase: N/A
• First received: December 4, 2012
• Last updated: November 28, 2013
• Start date: September 2012
• Est. completion date: August 2013

Study information

• Verified date: November 2013
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to show if the six-minute stepper test (ST6) is a sensible marker of exercise tolerance evolution during a pulmonary rehabilitation program in people with all stages of severity of Chronic Obstructive Pulmonary Disease (COPD).

Description:

Currently, the reference test in assessing functional capacity in COPD patients during pulmonary rehabilitation is the six-Minute Walking Test (6MWT). However, the realization of the 6MWT requires a 30m-long corridor, according to the American Thoracic Society Guidelines. Lack of sufficient space can prevent the realization of 6MWT, especially for private practitioner pulmonologists, and also in hospitals. The six-minute stepper test (ST6) which can be performed in a normal room, should be an interesting alternative.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with COPD wtih all stages of severity

• Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix, with a 3 weeks pulmonary rehabilitation course

Exclusion Criteria:

• Pneumonectomy, Lobectomy less than 6 months

• orthopedic problem

• Balance disorder

• Weight > 110kg

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Pulmonary rehabilitation assessed with six-minute walk test and six-minute stepper test

Locations

Country	Name	City	State
France	Brest University Hospital	Brest,	Brittany
France	Hospital of Morlaix	Morlaix	Brittany
France	Hospital of Morlaix	Morlaix, Brittany

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Brest	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of steps to The Six-minute Stepper Test (ST6)	Assess the difference in the number of steps in ST6 before and after pulmonary rehabilitation	21 days	No