Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-25 @ 1:49 PM
Study NCT ID:
NCT03793192
Status:
TERMINATED
Last Update Posted:
2025-01-20
First Post:
2019-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Promoting Activity After COPD Exacerbations, Aim 2
Sponsor:
University of Illinois at Chicago
Organization:
Study Overview
Official Title:
Promoting Activity After COPD Exacerbations, Aim 2 (PACE2)
Status:
TERMINATED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI leaving institution, data collected is insufficient for analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACE2
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5K23HL130524-03 | NIH | None | https://reporter.nih.gov/quic… | View |