NCT01759199

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 3, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

December 3, 2025

Status Verified

November 1, 2013

Enrollment Period

11 months

First QC Date

December 4, 2012

Last Update Submit

November 26, 2025

Conditions

Keywords

COPDST6: The six minute Stepper TestConventional respiratory rehabilitationPulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

The six minute Stepper Test

EXPERIMENTAL

Experimental : The six minute Stepper Test with a Conventional respiratory rehabilitation

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

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pneumonectomy, Lobectomy less than 6 months
  • orthopedic problem
  • Balance disorder
  • Weight \> 110kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Brest University Hospital

Brest, Brittany Region, 29200, France

Location

Hospital of Morlaix

Morlaix, Brittany Region, 29600, France

Location

Hospital of Morlaix

Morlaix, Brittany, 29600, France

Location

Related Publications (1)

  • Pichon R, Couturaud F, Mialon P, Le Ber-Moy C, Peran L, Lochon C, Nowak E, Beaumont M. Responsiveness and Minimally Important Difference of the 6-Minute Stepper Test in Patients with Chronic Obstructive Pulmonary Disease. Respiration. 2016;91(5):367-73. doi: 10.1159/000446517. Epub 2016 May 25.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • FRANCIS COUTURAUD, MD,PHD

    Brest University Hospital Brest,, Brittany, France 29200

    PRINCIPAL INVESTIGATOR
  • CATHERINE LE BER-MOY, DR.

    Hospital of Morlaix Morlaix, Brittany, France 29600

    PRINCIPAL INVESTIGATOR
  • CHANTAL LOCHON, DR.

    Hospital of Morlaix Morlaix, Brittany, France 29600

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2012

First Posted

January 3, 2013

Study Start

September 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

December 3, 2025

Record last verified: 2013-11

Locations