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 is currently recruiting participants.
Verified December 2012 by University Hospital, Brest
Sponsor:
University Hospital, Brest
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01759199
First received: December 4, 2012
Last updated: December 27, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Exercise and Physical Fitness
Rehabilitation
U.S. FDA Resources
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
| Estimated Enrollment: | 62 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759199
Locations
| France | |
| Brest University Hospital | Recruiting |
| Brest,, Brittany, France, 29200 | |
| Contact: Francis COUTURAUD, MD, PHD 00 33 2 98 34 73 49 francis.couturaud@chu-brest.fr | |
| Hospital of Morlaix | Recruiting |
| Morlaix, Brittany, France, 29600 | |
| Contact: ROMAIN PICHON 00332 98 62 61 60 respi-guervenan@ch-morlaix.fr | |
| Contact: MARC BEAUMONT 00332 98 62 61 60 respi-guervenan@ch-morlaix.fr | |
| Sub-Investigator: CATHERINE LE BER-MOY, DR. | |
| Sub-Investigator: CHANTAL LOCHON, DR. | |
| Hospital of Morlaix | Recruiting |
| Morlaix, Brittany, France, 29600 | |
| Contact: MARC BEAUMONT 00332 98 62 61 60 respi-guervenan@ch-morlaix.fr | |
| Hospital of Morlaix | Recruiting |
| Morlaix, Brittany, France, 29600 | |
| Contact: LOIC PERAN 00332 98 62 61 60 respi-guervenan@ch-morlaix.fr | |
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: | December 27, 2012 |
| 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 Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013