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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01759199
First received: December 4, 2012
Last updated: November 28, 2013
Last verified: November 2013
  Purpose

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).


Condition Intervention
Chronic Obstructive Pulmonary Disease
Procedure: Pulmonary rehabilitation assessed with six-minute walk test and six-minute stepper test

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Six-minute Stepper Test : Marker of Exercise Tolerance's Evolution During Pulmonary Rehabilitation in Patients With COPD ?

Resource links provided by NLM:


Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • The number of steps to The Six-minute Stepper Test (ST6) [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Assess the difference in the number of steps in ST6 before and after pulmonary rehabilitation


Enrollment: 72
Study Start Date: September 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: The six minute Stepper Test
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759199

Locations
France
Brest University Hospital
Brest,, Brittany, France, 29200
Hospital of Morlaix
Morlaix, Brittany, France, 29600
Hospital of Morlaix
Morlaix, Brittany, France, 29600
Sponsors and Collaborators
University Hospital, Brest
Ministry of Health, France
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01759199     History of Changes
Other Study ID Numbers: RB 11-157 STEPPER
Study First Received: December 4, 2012
Last Updated: November 28, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Brest:
COPD
ST6: The six minute Stepper Test
Conventional respiratory rehabilitation
Pulmonary rehabilitation

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 26, 2014