Environment Effect on Six-Minute Walk Test Performance

NCT02502201 | Terminated DMC

• 1 other identifier: IRB201500220
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Alpha-1 Antitrypsin Deficiency

Keywords

six-minute walk

Outcome Measures

Primary Outcomes (1)

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

  baseline

Secondary Outcomes (2)

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

  baseline

• Change in Borg Scale for fatigue between the two groups

  baseline

Study Arms (4)

six-minute walk study indoors first

ACTIVE COMPARATOR

Participants randomized to indoor six-minute walk test first

Other: six-minute walk study indoors

six-minute walk study outdoors first

EXPERIMENTAL

Participants randomized to outdoor six-minute walk test first

Other: six-minute walk study outdoors

six-minute walk study indoors second

ACTIVE COMPARATOR

Participants randomized to indoor six-minute walk test second

Other: six-minute walk study indoors

six-minute walk study outdoors second

EXPERIMENTAL

Participants randomized to outdoor six-minute walk test second

Other: six-minute walk study outdoors

Interventions

six-minute walk study indoors OTHER

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

six-minute walk study indoors first; six-minute walk study indoors second

six-minute walk study outdoors OTHER

Performance of a six-minute walk test.

six-minute walk study outdoors first; six-minute walk study outdoors second

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Uf Ctsi Crc

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; alpha 1-Antitrypsin Deficiency

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Subcutaneous Emphysema; Emphysema

Study Officials

• Mark Brantly, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: July 20, 2015
• Study Start: October 1, 2015
• Primary Completion: August 30, 2017
• Study Completion: August 30, 2017
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)