Back to resultsThe Six-minute Stepper Test as an Outcome Measure of Exercise Tolerance During Pulmonary Rehabilitation in With Chronic Obstructive Pulmonary Disease (COPD) Patients(STEPPER)? (STEPPER)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pulmonary rehabilitation assessed with six-minute walk test and six-minute stepper test
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, ST6: The six minute Stepper Test, Conventional respiratory rehabilitation, Pulmonary rehabilitation
Eligibility 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
Sites / Locations
- Brest University Hospital
- Hospital of Morlaix
- Hospital of Morlaix
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
The six minute Stepper Test
Arm Description
Experimental : The six minute Stepper Test with a Conventional respiratory rehabilitation
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01759199
First Posted
December 4, 2012
Last Updated
November 28, 2013
Sponsor
University Hospital, Brest
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT01759199
Brief Title
The Six-minute Stepper Test as an Outcome Measure of Exercise Tolerance During Pulmonary Rehabilitation in With Chronic Obstructive Pulmonary Disease (COPD) Patients(STEPPER)?
Acronym
STEPPER
Official Title
The Six-minute Stepper Test : Marker of Exercise Tolerance's Evolution During Pulmonary Rehabilitation in Patients With COPD ?
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
Collaborators
Ministry of Health, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, ST6: The six minute Stepper Test, Conventional respiratory rehabilitation, Pulmonary rehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The six minute Stepper Test
Arm Type
Experimental
Arm Description
Experimental : The six minute Stepper Test with a Conventional respiratory rehabilitation
Intervention Type
Procedure
Intervention Name(s)
Pulmonary rehabilitation assessed with six-minute walk test and six-minute stepper test
Primary Outcome Measure Information:
Title
The number of steps to The Six-minute Stepper Test (ST6)
Description
Assess the difference in the number of steps in ST6 before and after pulmonary rehabilitation
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FRANCIS COUTURAUD, MD,PHD
Organizational Affiliation
Brest University Hospital Brest,, Brittany, France 29200
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
CATHERINE LE BER-MOY, DR.
Organizational Affiliation
Hospital of Morlaix Morlaix, Brittany, France 29600
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
CHANTAL LOCHON, DR.
Organizational Affiliation
Hospital of Morlaix Morlaix, Brittany, France 29600
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brest University Hospital
City
Brest,
State/Province
Brittany
ZIP/Postal Code
29200
Country
France
Facility Name
Hospital of Morlaix
City
Morlaix
State/Province
Brittany
ZIP/Postal Code
29600
Country
France
Facility Name
Hospital of Morlaix
City
Morlaix, Brittany
ZIP/Postal Code
29600
Country
France
12. IPD Sharing Statement
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The Six-minute Stepper Test as an Outcome Measure of Exercise Tolerance During Pulmonary Rehabilitation in With Chronic Obstructive Pulmonary Disease (COPD) Patients(STEPPER)?
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