Chronic Obstructive Pulmonary Disease6MWTAATDNCT02502201
Environment Effect on Six-Minute Walk Test Performance
A study testing six-minute walk study indoors and six-minute walk study outdoors in people with Chronic Obstructive Pulmonary Disease and Alpha-1 Antitrypsin Deficiency, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to determine the effect of the environment on six-minute walk test performance in individuals with chronic obstructive pulmonary disease due to alpha-1 antitrypsin deficiency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Alpha-1 Antitrypsin Deficiency
- What is being tested?
- six-minute walk study indoors and six-minute walk study outdoors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 30 Aug 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years.
- Have a diagnosis of congenital Alpha-1 Antitrypsin Deficiency with an allelic combination of ZZ.
- Have a Forced Expiratory Volume in 1 second (FEV1)< 50% of predicted and FEV1/forced vital capacity (FVC) < 70% (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage II, III, or IV).
- Not currently prescribed Oxygen replacement at a rate of greater than 2 liters.
- Willing and able to perform two six-minute walk tests.
- Willing and able to provide written informed consent.
Who cannot join
- Subject has had a moderate or severe pulmonary exacerbation during the 4 weeks before the study visit.
- History of lung transplant.
- Severe concomitant disease (e.g., congestive heart failure, clinically significant pulmonary fibrosis, malignant disease [with the exception of skin cancers other than melanoma], history of acute hypersensitivity pneumonitis reaction, or current chronic hypersensitivity pneumonitis).
- Unwilling or unable to perform six-minute walk testing.
- Mentally challenged adult subjects who cannot give independent informed consent.
- In the opinion of the investigator the subject may have compliance problems with the protocol and the procedures of the protocol.
- American Thoracic Society listed absolute contraindications to six-minute walk test: unstable angina or myocardial infarction during previous month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Environment on Six-minute Walk Test Performance in Individuals With Alpha-1 Antitrypsin Deficiency-Related Chronic Obstructive Pulmonary Disease
The purpose of this research study is to determine the effect of the environment on six-minute walk test performance in individuals with chronic obstructive pulmonary disease due to alpha-1 antitrypsin deficiency. The aim of the study is to determine the environmental impact on physical performance in this population to determine if any factors influence quality of life. This study was developed to evaluate the efficacy of the using the indoor six-minute walk test to determine eligibility for ambulatory oxygen therapy.
Read the detailed description
Participants will be asked to come to the Clinical Research Center (CRC) for a visit lasting about one hour. Participants will be asked to review and sign an informed consent document to participate in this trial. If participants agree to participate and sign the consent, the following procedures will be done. If they have not had pulmonary function testing performed in the past 18 months, standard spirometry testing will be performed. Participants will perform two six-minute walk tests, one indoors and one outdoors. First, they will be randomly assigned to perform either the indoor or outdoor testing first. Then participants will have their vital signs taken, perform the first six-minute walk study and immediately after have their vital signs taken again. Participants will have a rest period between the two six-minute walk tests of at least 30 minutes. Participants will then perform the second six-minute walk test with the same above procedures for the first test.
- Being tested
- six-minute walk study indoors, six-minute walk study outdoors
- Keywords
- six-minute walk
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, alpha 1-Antitrypsin Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
six-minute walk study indoorsOther
Performance of a six-minute walk test according to American Thoracic Society standard.
six-minute walk study outdoorsOther
Performance of a six-minute walk test.
| Study group | Role | What they receive |
|---|---|---|
| six-minute walk study indoors first | Active comparator | Participants randomized to indoor six-minute walk test first Receives: Other: six-minute walk study indoors |
| six-minute walk study outdoors first | Experimental | Participants randomized to outdoor six-minute walk test first Receives: Other: six-minute walk study outdoors |
| six-minute walk study indoors second | Active comparator | Participants randomized to indoor six-minute walk test second Receives: Other: six-minute walk study indoors |
| six-minute walk study outdoors second | Experimental | Participants randomized to outdoor six-minute walk test second Receives: Other: six-minute walk study outdoors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the meters walked during the six-minute walk test between the two groups.
Measured: baseline
Secondary outcomes (2)
Change in Borg Scale for shortness of breath between the two groups
The Borg Scale a numerical scale for assessing shortness of breath, from 0 representing no shortness of breath to 10 as maximal shortness of breath.
Measured: baseline
Change in Borg Scale for fatigue between the two groups
The Borg Scale a numerical scale for assessing shortness of breath, from 0 representing no shortness of breath to 10 as maximal shortness of breath.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startOct 2015
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Why it stopped: Difficulty finding participants who fit all criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Brantly, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502201
- Sponsor's protocol ID
- IRB201500220
- Acronym
- 6MWTAATD
- Status last verified
- Aug 2019
- First submitted
- 9 Jun 2015
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Environment on Six-minute Walk Test Performance in Individuals With Alpha-1 Antitrypsin Deficiency-Related Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02502201
- Acronym / sponsor ID
- 6MWTAATD / IRB201500220
- Keywords
- six-minute walk
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty finding participants who fit all criteria
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 20 Jul 2015 (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 purpose of this research study is to determine the effect of the environment on six-minute walk test performance in individuals with chronic obstructive pulmonary disease due to alpha-1 antitrypsin deficiency. The aim of the study is to determine the environmental impact on physical performance in this population to determine if any factors influence quality of life. This study was developed to evaluate the efficacy of the using the indoor six-minute walk test to determine eligibility for ambulatory oxygen therapy.
Detailed description
Participants will be asked to come to the Clinical Research Center (CRC) for a visit lasting about one hour. Participants will be asked to review and sign an informed consent document to participate in this trial. If participants agree to participate and sign the consent, the following procedures will be done. If they have not had pulmonary function testing performed in the past 18 months, standard spirometry testing will be performed. Participants will perform two six-minute walk tests, one indoors and one outdoors. First, they will be randomly assigned to perform either the indoor or outdoor testing first. Then participants will have their vital signs taken, perform the first six-minute walk study and immediately after have their vital signs taken again. Participants will have a rest period between the two six-minute walk tests of at least 30 minutes. Participants will then perform the second six-minute walk test with the same above procedures for the first test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| six-minute walk study indoors first | Active comparator | Other: six-minute walk study indoorsParticipants randomized to indoor six-minute walk test first |
| six-minute walk study outdoors first | Experimental | Other: six-minute walk study outdoorsParticipants randomized to outdoor six-minute walk test first |
| six-minute walk study indoors second | Active comparator | Other: six-minute walk study indoorsParticipants randomized to indoor six-minute walk test second |
| six-minute walk study outdoors second | Experimental | Other: six-minute walk study outdoorsParticipants randomized to outdoor six-minute walk test second |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age above 18 years.
- Have a diagnosis of congenital Alpha-1 Antitrypsin Deficiency with an allelic combination of ZZ.
- Have a Forced Expiratory Volume in 1 second (FEV1)< 50% of predicted and FEV1/forced vital capacity (FVC) < 70% (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage II, III, or IV).
- Not currently prescribed Oxygen replacement at a rate of greater than 2 liters.
- Willing and able to perform two six-minute walk tests.
Key exclusion criteria (7 listed)
- Subject has had a moderate or severe pulmonary exacerbation during the 4 weeks before the study visit.
- History of lung transplant.
- Severe concomitant disease (e.g., congestive heart failure, clinically significant pulmonary fibrosis, malignant disease [with the exception of skin cancers other than melanoma], history of acute hypersensitivity pneumonitis reaction, or current chronic hypersensitivity pneumonitis).
- Unwilling or unable to perform six-minute walk testing.
- Mentally challenged adult subjects who cannot give independent informed consent.
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 |
|---|---|---|
| six-minute walk study indoorsPerformance of a six-minute walk test according to American Thoracic Society standard. | Other | six-minute walk study indoors first, six-minute walk study indoors second |
| six-minute walk study outdoorsPerformance of a six-minute walk test. | Other | six-minute walk study outdoors first, six-minute walk study outdoors second |
Primary outcome
Change in the meters walked during the six-minute walk test between the two groups.
Time frame: baseline
2 secondary outcomes
Change in Borg Scale for shortness of breath between the two groups
Time frame: baseline
Change in Borg Scale for fatigue between the two groups
Time frame: baseline
Results and safety
The study was stopped early (reason given: Difficulty finding participants who fit all criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Mark Brantly, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing six-minute walk study indoors and six-minute walk study outdoors in people with Chronic Obstructive Pulmonary Disease and Alpha-1 Antitrypsin Deficiency, run by University of Florida 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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 22 Aug 2019. 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. 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 was stopped early (reason given: Difficulty finding participants who fit all criteria). Results are not available in the source record.
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 in the meters walked during the six-minute walk test between the two groups. (time frame: baseline). 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 22 Aug 2019.