Environment Effect on Six-Minute Walk Test Performance

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of the Environment on Six-minute Walk Test Performance in Individuals With Alpha-1 Antitrypsin Deficiency-Related Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease, Alpha-1 Antitrypsin Deficiency

Intervention / Treatment
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* Other: six-minute walk study indoors
* Other: six-minute walk study outdoors


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: six-minute walk study indoors first<br>Participants randomized to indoor six-minute walk test first | Other: six-minute walk study indoors<br>* Performance of a six-minute walk test according to American Thoracic Society standard.<br>|
| Experimental: six-minute walk study outdoors first<br>Participants randomized to outdoor six-minute walk test first | Other: six-minute walk study outdoors<br>* Performance of a six-minute walk test.<br>|
| Active Comparator: six-minute walk study indoors second<br>Participants randomized to indoor six-minute walk test second | Other: six-minute walk study indoors<br>* Performance of a six-minute walk test according to American Thoracic Society standard.<br>|
| Experimental: six-minute walk study outdoors second<br>Participants randomized to outdoor six-minute walk test second | Other: six-minute walk study outdoors<br>* Performance of a six-minute walk test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the meters walked during the six-minute walk test between the two groups. |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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six-minute walk