NCT02502201

Environment Effect on Six-Minute Walk Test Performance

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Chronic Obstructive Pulmonary Disease
• Alpha-1 Antitrypsin Deficiency

Interventions

Type	Name	Description
OTHER	six-minute walk study indoors	Performance of a six-minute walk test according to American Thoracic Society standard.
OTHER	six-minute walk study outdoors	Performance of a six-minute walk test.

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-08-30
• Completion: 2017-08-30
• First posted: 2015-07-20
• Last updated: 2019-08-22

Locations

1 site across 1 country: United States