Clinical trial NCT02502201: Environment Effect on Six-Minute Walk Test Performance
Official title: Effect of the Environment on Six-minute Walk Test Performance in Individuals With Alpha-1 Antitrypsin Deficiency-Related Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Alpha-1 Antitrypsin Deficiency
Keywords: six-minute walk
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2015-07-20
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Age above 18 years.
2. Have a diagnosis of congenital Alpha-1 Antitrypsin Deficiency with an allelic combination of ZZ.
3. 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).
4. Not currently prescribed Oxygen replacement at a rate of greater than 2 liters.
5. Willing and able to perform two six-minute walk tests.
6. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Subject has had a moderate or severe pulmonary exacerbation during the 4 weeks before the study visit.
2. History of lung transplant.
3. 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).
4. Unwilling or unable to perform six-minute walk testing.
5. Mentally challenged adult subjects who cannot give independent informed consent.
6. In the opinion of the investigator the subject may have compliance problems with the protocol and the procedures of the protocol.
7. American Thoracic Society listed absolute contraindications to six-minute walk test: unstable angina or myocardial infarction during previous month.

Primary outcomes:
measure: Change in the meters walked during the six-minute walk test between the two groups.
timeFrame: baseline
Secondary outcomes:
measure: Change in Borg Scale for shortness of breath between the two groups
timeFrame: baseline
measure: Change in Borg Scale for fatigue between the two groups
timeFrame: baseline
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Uf Ctsi Crc
state: Florida
Study officials:
affiliation: University of Florida
name: Mark Brantly, MD
role: PRINCIPAL_INVESTIGATOR
References: