Environment Effect on Six-Minute Walk Test Performance

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Brief Title

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

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.
    


Study Type

Interventional


Primary Outcome

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

Secondary Outcome

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

Condition

Chronic Obstructive Pulmonary Disease

Intervention

six-minute walk study indoors

Study Arms / Comparison Groups

 six-minute walk study indoors first
Description:  Participants randomized to indoor six-minute walk test first

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

27

Start Date

October 2015

Completion Date

August 30, 2017

Primary Completion Date

August 30, 2017

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Mark Brantly, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02502201

Organization ID

IRB201500220


Responsible Party

Sponsor

Study Sponsor

University of Florida


Study Sponsor

Mark Brantly, MD, Principal Investigator, University of Florida


Verification Date

August 2019