- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02502201
Environment Effect on Six-Minute Walk Test Performance (6MWTAATD)
August 20, 2019 updated by: University of Florida
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.
Study Overview
Status
Terminated
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610
- Uf Ctsi Crc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: six-minute walk study indoors first
Participants randomized to indoor six-minute walk test first
|
Performance of a six-minute walk test according to American Thoracic Society standard.
|
Experimental: six-minute walk study outdoors first
Participants randomized to outdoor six-minute walk test first
|
Performance of a six-minute walk test.
|
Active Comparator: six-minute walk study indoors second
Participants randomized to indoor six-minute walk test second
|
Performance of a six-minute walk test according to American Thoracic Society standard.
|
Experimental: six-minute walk study outdoors second
Participants randomized to outdoor six-minute walk test second
|
Performance of a six-minute walk test.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the meters walked during the six-minute walk test between the two groups.
Time Frame: baseline
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Borg Scale for shortness of breath between the two groups
Time Frame: baseline
|
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.
|
baseline
|
Change in Borg Scale for fatigue between the two groups
Time Frame: baseline
|
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.
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
August 30, 2017
Study Completion (Actual)
August 30, 2017
Study Registration Dates
First Submitted
June 9, 2015
First Submitted That Met QC Criteria
July 16, 2015
First Posted (Estimate)
July 20, 2015
Study Record Updates
Last Update Posted (Actual)
August 22, 2019
Last Update Submitted That Met QC Criteria
August 20, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201500220
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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