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Environment Effect on Six-Minute Walk Test Performance (6MWTAATD)

Primary Purpose

Chronic Obstructive Pulmonary Disease, Alpha-1 Antitrypsin Deficiency

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

six-minute walk study indoors

six-minute walk study outdoors

About this trial

This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease focused on measuring six-minute walk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Uf Ctsi Crc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

six-minute walk study indoors first

six-minute walk study outdoors first

six-minute walk study indoors second

six-minute walk study outdoors second

Arm Description

Participants randomized to indoor six-minute walk test first

Participants randomized to outdoor six-minute walk test first

Participants randomized to indoor six-minute walk test second

Participants randomized to outdoor six-minute walk test second

Outcomes

Primary Outcome Measures

Change in the meters walked during the six-minute walk test between the two groups.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT02502201

First Posted

June 9, 2015

Last Updated

August 20, 2019

Sponsor

University of Florida

1. Study Identification

Unique Protocol Identification Number

NCT02502201

Brief Title

Environment Effect on Six-Minute Walk Test Performance

Acronym

6MWTAATD

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

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Terminated

Why Stopped

Difficulty finding participants who fit all criteria

Study Start Date

October 2015 (undefined)

Primary Completion Date

August 30, 2017 (Actual)

Study Completion Date

August 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease, Alpha-1 Antitrypsin Deficiency

Keywords

six-minute walk

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

six-minute walk study indoors first

Arm Type

Active Comparator

Arm Description

Participants randomized to indoor six-minute walk test first

Arm Title

six-minute walk study outdoors first

Arm Type

Experimental

Arm Description

Participants randomized to outdoor six-minute walk test first

Arm Title

six-minute walk study indoors second

Arm Type

Active Comparator

Arm Description

Participants randomized to indoor six-minute walk test second

Arm Title

six-minute walk study outdoors second

Arm Type

Experimental

Arm Description

Participants randomized to outdoor six-minute walk test second

Intervention Type

Other

Intervention Name(s)

six-minute walk study indoors

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

six-minute walk study outdoors

Intervention Description

Performance of a six-minute walk test.

Primary Outcome Measure Information:

Title

Change in the meters walked during the six-minute walk test between the two groups.

Time Frame

baseline

Secondary Outcome Measure Information:

Title

Change in Borg Scale for shortness of breath between the two groups

Description

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.

Time Frame

baseline

Title

Change in Borg Scale for fatigue between the two groups

Description

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.

Time Frame

baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Brantly, MD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

Uf Ctsi Crc

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Environment Effect on Six-Minute Walk Test Performance

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