Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Chronic Obstructive Pulmonary Disease
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Intervention versus Enhanced Usual CareMasking: Single (Outcomes Assessor)Masking Description: Allocation sequence will be concealedPrimary Purpose: Other

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Deconditioning is common in patients with chronic obstructive pulmonary disease (COPD) and has been associated with poor outcomes (e.g. difficulty breathing). Pulmonary rehabilitation (PR) initiated shortly after hospital discharge following a COPD exacerbation has been shown to improve some of thes...

Deconditioning is common in patients with chronic obstructive pulmonary disease (COPD) and has been associated with poor outcomes (e.g. difficulty breathing). Pulmonary rehabilitation (PR) initiated shortly after hospital discharge following a COPD exacerbation has been shown to improve some of these outcomes. However, for many patients, access to PR programs is limited due to environmental, physical, and psycho-social reasons. Home-based physical activity promotion, combined with education and social support, could help to overcome some barriers to access and have been shown to be effective in populations with mild to moderate COPD. However, home-based interventions have not been tested in patients recovering from COPD exacerbations, a group for whom solutions to safely promote physical activity are urgently needed. In PACE2 up to 64 adult participants with a physician diagnosis of COPD will be enrolled and randomized to one of two groups: physical activity promotion intervention or enhanced usual care. Participants will be enrolled while hospitalized and randomization will occur approximately 7 days after hospital discharge. All participants will be provided self-management educational materials and community resources both prior to hospital discharge and during a home visit shortly after hospital discharge. For the participants randomized to the intervention group, physical activity promotion will start following randomization and continue for 12 weeks. These participants will also receive a personalized plan to attend pulmonary rehabilitation, a guideline-recommended program for patients with COPD recovering from exacerbations. The primary endpoint will be the change in physical activity (mean daily step counts over 1 week) over time using repeated measures over the 12 weeks of the study.

Tracking Information

NCT #
NCT03793192
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Jerry Krishnan, MD University of Illinois at Chicago