Environment Effect on Six-Minute Walk Test Performance

NCT ID: NCT02502201

Last Updated: 2019-08-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-08-30

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.

Conditions

Chronic Obstructive Pulmonary Disease; Alpha-1 Antitrypsin Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

six-minute walk study indoors first

Participants randomized to indoor six-minute walk test first

Group Type: ACTIVE_COMPARATOR

six-minute walk study indoors

Intervention Type: OTHER

Performance of a six-minute walk test according to American Thoracic Society standard.

six-minute walk study outdoors first

Participants randomized to outdoor six-minute walk test first

Group Type: EXPERIMENTAL

six-minute walk study outdoors

Intervention Type: OTHER

Performance of a six-minute walk test.

six-minute walk study indoors second

Participants randomized to indoor six-minute walk test second

Group Type: ACTIVE_COMPARATOR

six-minute walk study indoors

Intervention Type: OTHER

Performance of a six-minute walk test according to American Thoracic Society standard.

six-minute walk study outdoors second

Participants randomized to outdoor six-minute walk test second

Group Type: EXPERIMENTAL

six-minute walk study outdoors

Intervention Type: OTHER

Performance of a six-minute walk test.

Interventions

six-minute walk study indoors

Performance of a six-minute walk test according to American Thoracic Society standard.

Intervention Type: OTHER

six-minute walk study outdoors

Performance of a six-minute walk test.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Brantly, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Uf Ctsi Crc

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB201500220

Identifier Type: -

Identifier Source: org_study_id