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Dyspnea Threshold During 6 Minutes Walk Test (SD6)

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ClinicalTrials.gov Identifier: NCT02082925
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : March 10, 2014
Sponsor:
Information provided by (Responsible Party):
5 Santé

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).


Condition or disease Intervention/treatment Phase
COPD Other: Patient has to get up his hand when he defined his dyspnea threshold during 6MWT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : January 2014
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: COPD patient Other: Patient has to get up his hand when he defined his dyspnea threshold during 6MWT



Primary Outcome Measures :
  1. Change of heart rate between 1st and 2nd 6MWT [ Time Frame: at baseline (2 days after entry in pulmonary rehabilitation) ]

Secondary Outcome Measures :
  1. Change of heart rate between VT (CPET) and DT6 (6MWT) [ Time Frame: At baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082925


Locations
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France
Clinique du Souffle La Vallonie
Lodève, France, 34700
Sponsors and Collaborators
5 Santé
Investigators
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Study Director: Nelly HERAUD
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Responsible Party: 5 Santé
ClinicalTrials.gov Identifier: NCT02082925    
Other Study ID Numbers: FVIE_SD6
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: March 10, 2014
Last Verified: March 2014
Keywords provided by 5 Santé:
Exercise training
Dyspnea threshold
6MWT
Additional relevant MeSH terms:
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Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory