Back to resultsDyspnea Threshold During 6 Minutes Walk Test (SD6)
Primary Purpose
COPD
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patient has to get up his hand when he defined his dyspnea threshold during 6MWT
Sponsored by
About this trial
This is an interventional diagnostic trial for COPD focused on measuring Exercise training, Dyspnea threshold, 6MWT
Eligibility Criteria
Inclusion Criteria:
- COPD
- with or without rest and/or ambulation oxygen therapy
Exclusion Criteria:
- exacerbation in the previous four weeks
- with a restrictive or mixed respiratory syndrome, angina , recent heart attack (< 1 month) or coronary progressive pathology
- under beta-blockers
- cognitive or motor problems which limit significantly comprehension or achievement of evaluations
Sites / Locations
- Clinique du Souffle La Vallonie
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
COPD patient
Arm Description
Outcomes
Primary Outcome Measures
Change of heart rate between 1st and 2nd 6MWT
Secondary Outcome Measures
Change of heart rate between VT (CPET) and DT6 (6MWT)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02082925
Brief Title
Dyspnea Threshold During 6 Minutes Walk Test
Acronym
SD6
Official Title
Self-perception of Dyspnea Threshold During the 6-minute Walk Test (DT6): A New Tool for Individualized Exercise Training With Chronic Obstructive Pulmonary Disease Patients (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
5 Santé
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In view of the multiple limitations and restrictions relative to CPET (technical, time, physical…), determination of individualized training threshold from this evaluation is today not possible for a lot of patients.
The aim of this study was to propose a new clinical tool from 6MWT for individualized exercise training: the dyspnea threshold (DT6).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
Exercise training, Dyspnea threshold, 6MWT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COPD patient
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Patient has to get up his hand when he defined his dyspnea threshold during 6MWT
Primary Outcome Measure Information:
Title
Change of heart rate between 1st and 2nd 6MWT
Time Frame
at baseline (2 days after entry in pulmonary rehabilitation)
Secondary Outcome Measure Information:
Title
Change of heart rate between VT (CPET) and DT6 (6MWT)
Time Frame
At baseline
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD
with or without rest and/or ambulation oxygen therapy
Exclusion Criteria:
exacerbation in the previous four weeks
with a restrictive or mixed respiratory syndrome, angina , recent heart attack (< 1 month) or coronary progressive pathology
under beta-blockers
cognitive or motor problems which limit significantly comprehension or achievement of evaluations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelly HERAUD
Official's Role
Study Director
Facility Information:
Facility Name
Clinique du Souffle La Vallonie
City
Lodève
ZIP/Postal Code
34700
Country
France
12. IPD Sharing Statement
Learn more about this trial
Dyspnea Threshold During 6 Minutes Walk Test
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