Portable Oxygen Concentrator to Improve Quality of Life in Chronic Obstructive Pulmonary Disease

Completed

Conditions studied: COPD

In brief

* Evaluate subjects in an prospective observational study * Subjects will be administered scientifically validated questionnaires * Determine the affect of the Portable Oxygen Concentrator (POC) on improvements in: 1. Exercise capability, dyspnea and quality of life as primary endpoints 2. Utilize: 1. Baseline Dyspnea Index (BDI) 2. Transitional Dyspnea Index (TDI) 3. Chronic Respiratory Disease Questionnaire (CRQ) 4. Six minute walk test (6MWT) 5. Epworth Sleepiness Scale (ESS) * The secondary endpoints will be: 1. Rate of exacerbations, sleep quality 2. Health care utilization (emergency room encounters, hospital admissions)

Key facts

Study ID

NCT01948544

Run by

StratiHealth

People needed

27

Starts

2013-09-01

Expected to finish

2014-04-01

Last updated by the study team

2018-08-20

Who can join

Age: 65 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary diagnosis of chronic obstructive pulmonary disease (COPD)
• Clinically stable disease at the time of consent
• Current prescription of oxygen; with previous or current oximetry suggesting desaturation at rest or during exercises (oxygen saturation ≤88% on at least one occasion)
• Highest measured FEV1, 70% predicted; and
• Highest measured FEV1/FVC, 70% predicted
• Capable of giving informed consent
• Currently using oxygen system that is either a portable tank; liquid or other Portable Oxygen Concentrator (POC)
• Mobility without a walker, cane or rollator
• Spo2 ≥ 92% on Portable Oxygen Concentrator (POC) at rest and activity
• Non-smoker at time of consent

You may not qualify if…

• Cardiovascular disease as defined in New York Heart Association Functional Class III
• Degenerative bone or joint disease that limits mobility and ability to perform activities of daily living and/or exercise
• Current homeless persons
• Active drug/alcohol dependence
• Recent abuse history within the past two years
• Clinically unstable at the time of consent
• Currently a tobacco smoker

Where it is running

• Tri-City Pulmonary Medical Group — Oceanside, California, United States
• Cardinal Medical Group — Vista, California, United States
• Pathway Medical Group — Westminster, California, United States

Full record on ClinicalTrials.gov

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