Randomized Trial of Physical Activity Self-Management Intervention for Patients With COPD

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01108991
• Date of registration: 21/04/2010
• Primary sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Public title: Randomized Trial of Physical Activity Self-Management Intervention for Patients With COPD COPD SMART
• Scientific title: Randomized Trial of Physical Activity Self-Management Intervention for Patients With COPD
• Date of first enrolment: April 2010
• Target sample size: 300
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01108991
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Countries of recruitment

United States

Contacts

• Name: Rennie Russo, MA

• Name: Rennie Russo, MA

• Name: David B Coultas, MD
• Affiliation: University of Texas Health Science Center-Tyler

Key inclusion & exclusion criteria

Inclusion Criteria:

- A physician diagnosis of COPD

- Age 45 years and older

- Affirmative response to "Are you short of breath when hurrying on the level or
walking up a slight hill?"

- Post-bronchodilator FEV1/FVC <0.7 and FEV1 <70%

Exclusion Criteria:

- Inability to speak/read English

- Lives in a chronic care facility (i.e., nursing home, assisted living)

- Plans to move from the area within the next 18 months

- Life expectancy less than 12 months

- Participation in pulmonary rehabilitation or other clinical research in the past 12
months

- Inability to walk without assistance of a wheelchair or walker

- Inability to walk at least 110m on a 6-minute walk

- Uncontrolled angina, hypertension, psychiatric illness, or dementia

- Inability to obtain supplemental oxygen if indicated



Age minimum: 45 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease

Intervention(s)

Behavioral: Physical activity self-management education

Primary Outcome(s)

6-minute walk [Time Frame: 6, 12, and 18 months]

Chronic Respiratory Disease Questionnaire [Time Frame: 6, 12, and 18 months]

Secondary Outcome(s)

Cost-effectiveness [Time Frame: 18 months]

Self-reported adverse event reporting [Time Frame: monthly for 18 months]

Secondary ID(s)

679

R18HL092955-01A1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of North Texas Health Science Center

University of Texas