Interstitial Lung DiseaseNCT01789996
The Six Minute Walk Test: Influence of Instruction on Results
A study testing alternative six minute walk test and Standard six minute walk test in people with Interstitial Lung Disease, run by Inova Health Care Services at 1 site in United States.
Trial summary
Two - four 6MWT performed according to ATS standards. Each walk however had specifically altered wording and coaching performed in random order to determine differences in outcomes. One walk was done in the standard ATS fashion. One was done coaching to walk as fast as the patient can walk. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- alternative six minute walk test and Standard six minute walk test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Dec 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- advanced lung disease such as COPD, ILD, IPF, or PAH
Who cannot join
- inability to walk, requiring supplemental oxygen, cardiac disease preventing successful 6MWT
Trial locations and contacts
1 site in 1 country.
United States1 site
Inova Advanced Lung Disease and Transplant Program
Falls Church, Virginia, 22042
About this study
Official title: Alternative Instruction in Six Minute Walk Test (6MWT)
Two - four 6MWT performed according to ATS standards. Each walk however had specifically altered wording and coaching performed in random order to determine differences in outcomes. One walk was done in the standard ATS fashion. One was done coaching to walk as fast as the patient can walk. One was coached to walk at the patients normal walking pace. One was coached to walk at the patient's leisure walking pace.
Read the detailed description
Alternate 6MWT where subjects will be asked to walk as fast as they can, walk as normal as they can and walk leisurely as they can in 6 minutes compared to standard of care 6MWT which is walk as far as you can in 6 minutes.
- Conditions
- Interstitial Lung Disease
- Being tested
- alternative six minute walk test, Standard six minute walk test
- Keywords
- 6 minute walk test, idiopathic pulmonary fibrosis, pulmonary arterial hypertension
- Medical subject headings
- Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alternative six minute walk testProcedure or surgery
Also called fast vs far
Alternate instructions will be given Subjects will
- walk as fast as they can in 6 minutes
- walk as normally as they can in 6 minutes
- walk leisurely as they can in 6 minutes. Pts will serve as their own controls.
Standard six minute walk testProcedure or surgery
Also called far
Subjects will walk as far as they can in 6 minutes
| Study group | Role | What they receive |
|---|---|---|
| Alternative six minute walk test | Active comparator | Subjects will be given the following instructions
1. walk as fast as they can in 6 minutes
2. walk as normally as they can in 6 minutes
3. walk leisurely as they can in 6 minutes. Pts will serve as their own controls. Receives: Procedure: alternative six minute walk test |
| Standard six minute walk test | Placebo comparator | Subjects will be given the following instruction
1. walk as far as they can in 6 minutes Receives: Procedure: Standard six minute walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
distance meters
this is an ongoing study of same day testing of 2-4 six minute walk tests, each with different instructions, to determine the impact of alternative instruction on outcome of the test
Measured: 1 day
Secondary outcomes (3)
oxygen saturation
assessed as an outcome of variable instruction given in different six minute walk tests performed in random order on the same day
Measured: 1 day
dyspnea score
assessed as an outcome of variable instruction given in different six minute
Measured: 1 day
heart rate response
assessed as an outcome of variable instruction given in different six minute
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startJun 2010
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Steven D Nathan, MD, Study director, Inova Advanced Lung Disease and Transplant Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789996
- Sponsor's protocol ID
- 10.089
- Status last verified
- Aug 2017
- First submitted
- 9 Feb 2013
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: We found that when the instruction was given to walk as fast as they can in six minutes, the distance was statistically greater than when the instruction was to walk as far as they can in six minutes. THe other instructions given yielded no difference in outcome. Other measures such are heart rate, Borg dyspnea score and saturation were not as statistically significant.
Publications
Weir NA, Brown AW, Shlobin OA, Smith MA, Reffett T, Battle E, Ahmad S, Nathan SD. The influence of alternative instruction on 6-min walk test distance. Chest. 2013 Dec;144(6):1900-1905. doi: 10.1378/chest.13-0287.
PubMed 23975232
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternative Instruction in Six Minute Walk Test (6MWT)
- ClinicalTrials.gov ID
- NCT01789996
- Acronym / sponsor ID
- 10.089
- Conditions
- Interstitial Lung Disease
- Keywords
- 6 minute walk test, idiopathic pulmonary fibrosis, pulmonary arterial hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Feb 2013 (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.
Two - four 6MWT performed according to ATS standards. Each walk however had specifically altered wording and coaching performed in random order to determine differences in outcomes. One walk was done in the standard ATS fashion. One was done coaching to walk as fast as the patient can walk. One was coached to walk at the patients normal walking pace. One was coached to walk at the patient's leisure walking pace.
Detailed description
Alternate 6MWT where subjects will be asked to walk as fast as they can, walk as normal as they can and walk leisurely as they can in 6 minutes compared to standard of care 6MWT which is walk as far as you can in 6 minutes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alternative six minute walk test | Active comparator | Procedure: alternative six minute walk testSubjects will be given the following instructions 1. walk as fast as they can in 6 minutes 2. walk as normally as they can in 6 minutes 3. walk leisurely as they can in 6 minutes. Pts will serve as their own controls. |
| Standard six minute walk test | Placebo comparator | Procedure: Standard six minute walk testSubjects will be given the following instruction 1. walk as far as they can in 6 minutes |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- advanced lung disease such as COPD, ILD, IPF, or PAH
Key exclusion criteria (1 listed)
- inability to walk, requiring supplemental oxygen, cardiac disease preventing successful 6MWT
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 |
|---|---|---|
| alternative six minute walk testAlso: fast vs farAlternate instructions will be given Subjects will 1. walk as fast as they can in 6 minutes 2. walk as normally as they can in 6 minutes 3. walk leisurely as they can in 6 minutes. Pts will serve as their own controls. | Procedure or surgery | Alternative six minute walk test |
| Standard six minute walk testAlso: farSubjects will walk as far as they can in 6 minutes | Procedure or surgery | Standard six minute walk test |
Primary outcome
distance meters
Time frame: 1 day
this is an ongoing study of same day testing of 2-4 six minute walk tests, each with different instructions, to determine the impact of alternative instruction on outcome of the test
3 secondary outcomes
oxygen saturation
Time frame: 1 day
dyspnea score
Time frame: 1 day
heart rate response
Time frame: 1 day
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 16 Jun 2020.
- Derived from this study: PubMed 23975232Weir NA, Brown AW, Shlobin OA, Smith MA, Reffett T, Battle E, Ahmad S, Nathan SD. The influence of alternative instruction on 6-min walk test distance. Chest. 2013 Dec;144(6):1900-1905. doi: 10.1378/chest.13-0287.
- Individual participant dataSharing planned: No. We found that when the instruction was given to walk as fast as they can in six minutes, the distance was statistically greater than when the instruction was to walk as far as they can in six minutes. THe other instructions given yielded no difference in outcome. Other measures such are heart rate, Borg dyspnea score and saturation were not as statistically significant.
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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.
Steven D Nathan, MD study director
Inova Advanced Lung Disease and Transplant Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alternative six minute walk test and Standard six minute walk test in people with Interstitial Lung Disease, run by Inova Health Care Services at 1 site in United States.
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 1 inclusion and 1 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 16 Jun 2020. 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 United States. 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. Some participants in this study may receive a placebo. 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?
distance meters (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01789996, which also lists 1 linked publication.
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 16 Jun 2020.