COPDSD6NCT02082925
Dyspnea Threshold During 6 Minutes Walk Test
A study testing Patient has to get up his hand when he defined his dyspnea threshold during 6MWT in people with COPD, run by 5 Santé at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD
- What is being tested?
- Patient has to get up his hand when he defined his dyspnea threshold during 6MWT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- COPD
- with or without rest and/or ambulation oxygen therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
- Conditions
- COPD
- Being tested
- Patient has to get up his hand when he defined his dyspnea threshold during 6MWT
- Keywords
- Exercise training, Dyspnea threshold, 6MWT
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient has to get up his hand when he defined his dyspnea threshold during 6MWTOther
| Study group | Role | What they receive |
|---|---|---|
| COPD patient | Experimental | Not described Receives: Other: Patient has to get up his hand when he defined his dyspnea threshold during 6MWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of heart rate between 1st and 2nd 6MWT
Measured: at baseline (2 days after entry in pulmonary rehabilitation)
Secondary outcomes (1)
Change of heart rate between VT (CPET) and DT6 (6MWT)
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- 5 Santé
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nelly HERAUD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082925
- Sponsor's protocol ID
- FVIE_SD6
- Acronym
- SD6
- Status last verified
- Mar 2014
- First submitted
- 4 Mar 2014
- Last updated
- 10 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02082925
- Acronym / sponsor ID
- SD6 / FVIE_SD6
- Conditions
- COPD
- Keywords
- Exercise training, Dyspnea threshold, 6MWT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- 5 SantéUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 10 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patient | Experimental | Other: Patient has to get up his hand when he defined his dyspnea threshold during 6MWT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- COPD
- with or without rest and/or ambulation oxygen therapy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient has to get up his hand when he defined his dyspnea threshold during 6MWT | Other | COPD patient |
Primary outcome
Change of heart rate between 1st and 2nd 6MWT
Time frame: at baseline (2 days after entry in pulmonary rehabilitation)
1 secondary outcome
Change of heart rate between VT (CPET) and DT6 (6MWT)
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nelly HERAUD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient has to get up his hand when he defined his dyspnea threshold during 6MWT in people with COPD, run by 5 Santé at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of heart rate between 1st and 2nd 6MWT (time frame: at baseline (2 days after entry in pulmonary rehabilitation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2014.