Pulmonary HypertensionNCT01399983
Standardization of 6 Minute Walk Test
An observational study of Pulmonary Hypertension, run by Medical University of Graz at 1 site in Austria.
Trial summary
The 6 minute walk (6MW) gives information about the exercise capacity and it is an important tool for clinical decisions and for the prognostic evaluation of PH patients. The test is technically simple to perform, inexpensive and reproducible. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 29 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2011to Oct 2011
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with pulmonary hypertension or exercise-induced pulmonary hypertension assessed by right heart catheterisation
Who may be able to join
- diagnosis of pulmonary hypertension or exercise-induced pulmonary hypertension by right heart catheterisation
- informed consent
Who cannot join
- Myocardiac Infarct within the last 12 months
- Uncontrolled ventricular arrhythmia
- Uncontrolled bradycardic or tachycardic supraventricular arrhythmia
- relevant operations within the last 12 weeks
- change of the hemodynamic therapy within the last 6 weeks
- joint diseases or diseases of peripheral vessels and nerves which may make the results of the six minute walk test unreliable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Exercise Capacity and Standardization of Six Minute Walk Test in Patients With Pulmonary Hypertension
The 6 minute walk (6MW) gives information about the exercise capacity and it is an important tool for clinical decisions and for the prognostic evaluation of PH patients. The test is technically simple to perform, inexpensive and reproducible. During the 6MW O2 saturation, heart rate, walking distance (in this study after every minute) and the level of dyspnea (BORG-dyspnea scale) may be recorded; however, at present, mainly the walking distance is evaluated. The test is sometimes criticized, because of the dependence on the patient's motivation.
The purpose of the present study is to standardize the test by the incorporation of objective factors. The investigators are correlating the change of heart rate and dyspnea (BORG scale) with the achieved walking distance during subsequent examinations performed with different effort.
Read the detailed description
On two different days the patients have to absolve four 6MW on different levels of effort - on both days a traditional test will be performed and additionally a test with more effort or with less effort. The order of the tests will be randomized. These two days of the examinations should be within a maximum of three months, provided that there is no sign of relevant clinical changes. After every minute the walking distance is determined. Heart rate and the O2 saturation are measured by pulsoxymetry during the whole test. Every two minutes the patients are asked about their dyspnea (Borg scale).
The purpose of the present study is to standardize the test by the incorporation of objective factors and to detect the correlation between the walking distance and the level of effort during exercise. The investigators expect that the reliability and objectivity of 6MW may increase by the standardization.
The additionally performed cardiopulmonary exercise testing helps to evaluate and stratify patients.
- Conditions
- Pulmonary Hypertension
- Keywords
- six minute walk
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pulmonary hypertension | patients with pulmonary hypertension and with exercise-induced pulmonary hypertension take part |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of six minute walk distance between baseline measurement and measurement with more effort or less effort
distance at six minute walk performed by different efforts
Measured: the six minute walk test with a different effort is performed 1 hour after the baseline test. The second baseline test and the missing test with a different effort takes place within three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Horst Olschewski, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399983
- Sponsor's protocol ID
- 23-069 ex 10/11
- Status last verified
- Mar 2012
- First submitted
- 12 Jul 2011
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Exercise Capacity and Standardization of Six Minute Walk Test in Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT01399983
- Acronym / sponsor ID
- 23-069 ex 10/11
- Conditions
- Pulmonary Hypertension
- Keywords
- six minute walk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 22 Jul 2011 (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.
The 6 minute walk (6MW) gives information about the exercise capacity and it is an important tool for clinical decisions and for the prognostic evaluation of PH patients. The test is technically simple to perform, inexpensive and reproducible. During the 6MW O2 saturation, heart rate, walking distance (in this study after every minute) and the level of dyspnea (BORG-dyspnea scale) may be recorded; however, at present, mainly the walking distance is evaluated. The test is sometimes criticized, because of the dependence on the patient's motivation.
The purpose of the present study is to standardize the test by the incorporation of objective factors. The investigators are correlating the change of heart rate and dyspnea (BORG scale) with the achieved walking distance during subsequent examinations performed with different effort.
Detailed description
On two different days the patients have to absolve four 6MW on different levels of effort - on both days a traditional test will be performed and additionally a test with more effort or with less effort. The order of the tests will be randomized. These two days of the examinations should be within a maximum of three months, provided that there is no sign of relevant clinical changes. After every minute the walking distance is determined. Heart rate and the O2 saturation are measured by pulsoxymetry during the whole test. Every two minutes the patients are asked about their dyspnea (Borg scale).
The purpose of the present study is to standardize the test by the incorporation of objective factors and to detect the correlation between the walking distance and the level of effort during exercise. The investigators expect that the reliability and objectivity of 6MW may increase by the standardization.
The additionally performed cardiopulmonary exercise testing helps to evaluate and stratify patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pulmonary hypertension | – | –patients with pulmonary hypertension and with exercise-induced pulmonary hypertension take part |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with pulmonary hypertension or exercise-induced pulmonary hypertension assessed by right heart catheterisation
Key inclusion criteria (2 listed)
- diagnosis of pulmonary hypertension or exercise-induced pulmonary hypertension by right heart catheterisation
- informed consent
Key exclusion criteria (6 listed)
- Myocardiac Infarct within the last 12 months
- Uncontrolled ventricular arrhythmia
- Uncontrolled bradycardic or tachycardic supraventricular arrhythmia
- relevant operations within the last 12 weeks
- change of the hemodynamic therapy within the last 6 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change of six minute walk distance between baseline measurement and measurement with more effort or less effort
Time frame: the six minute walk test with a different effort is performed 1 hour after the baseline test. The second baseline test and the missing test with a different effort takes place within three months.
distance at six minute walk performed by different efforts
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 9 Mar 2012.
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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.
Horst Olschewski, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by Medical University of Graz at 1 site in Austria.
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 6 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 9 Mar 2012. 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 Austria. 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 six minute walk distance between baseline measurement and measurement with more effort or less effort (time frame: the six minute walk test with a different effort is performed 1 hour after the baseline test. The second baseline test and the missing test with a different effort takes place within three months.). 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 9 Mar 2012.