Dyspnea Threshold During 6 Minutes Walk Test

COPD Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082925
• Other study ID #: FVIE_SD6
• Status: Completed
• Phase: N/A
• First received: March 4, 2014
• Last updated: March 6, 2014
• Start date: January 2014
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: 5 Santé
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministère de l'Enseignement supérieur et de la Recherche
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• Patient has to get up his hand when he defined his dyspnea threshold during 6MWT

Locations

Country	Name	City	State
France	Clinique du Souffle La Vallonie	Lodève

Sponsors (1)

Lead Sponsor	Collaborator
5 Santé

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of heart rate between 1st and 2nd 6MWT		at baseline (2 days after entry in pulmonary rehabilitation)	No
Secondary	Change of heart rate between VT (CPET) and DT6 (6MWT)		At baseline	No