NCT02082925

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2014

Completed
Last Updated

March 10, 2014

Status Verified

March 1, 2014

Enrollment Period

2 months

First QC Date

March 4, 2014

Last Update Submit

March 6, 2014

Conditions

COPD

Keywords

Exercise trainingDyspnea threshold6MWT

Outcome Measures

Primary Outcomes (1)

  • Change of heart rate between 1st and 2nd 6MWT

    at baseline (2 days after entry in pulmonary rehabilitation)

Secondary Outcomes (1)

  • Change of heart rate between VT (CPET) and DT6 (6MWT)

    At baseline

Study Arms (1)

COPD patient

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

Interventions

Patient has to get up his hand when he defined his dyspnea threshold during 6MWTOTHER
COPD patient

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • COPD
  • with or without rest and/or ambulation oxygen therapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique du Souffle La Vallonie

Lodève, 34700, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nelly HERAUD

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 10, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 10, 2014

Record last verified: 2014-03

Locations

FR(1)