Clinical Trials Directory

Trials / Terminated

TerminatedNCT03793192

Promoting Activity After COPD Exacerbations, Aim 2

Promoting Activity After COPD Exacerbations, Aim 2 (PACE2)

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
7 (actual)
Sponsor
University of Illinois at Chicago · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This randomized controlled pilot study involving patients with chronic obstructive pulmonary disease (COPD) recently discharged from the hospital will evaluate the feasibility and efficacy of a home-based mobile-health supported physical activity promotion program.

Detailed 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 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.

Conditions

Interventions

TypeNameDescription
OTHERPACE2 InterventionWritten educational materials regarding physical activity, telephone-based coaching to integrate physical activity in daily life activities and address barriers to attending pulmonary rehabilitation.

Timeline

Start date
2019-03-18
Primary completion
2022-04-08
Completion
2022-04-08
First posted
2019-01-04
Last updated
2025-01-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03793192. Inclusion in this directory is not an endorsement.