Environment Effect on Six-Minute Walk Test Performance
Stopped early · Not applicable
Conditions studied: Chronic Obstructive Pulmonary Disease, Alpha-1 Antitrypsin Deficiency
In brief
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.
Key facts
- Study ID
- NCT02502201
- Run by
- University of Florida
- People needed
- 27
- Starts
- 2015-10-01
- Expected to finish
- 2017-08-30
- Last updated by the study team
- 2019-08-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Uf Ctsi Crc — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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