Promoting Activity After COPD Exacerbations, Aim 2

Chronic Obstructive Pulmonary Disease Clinical Trial

— PACE2  

Official title:

Promoting Activity After COPD Exacerbations, Aim 2 (PACE2)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03793192
• Other study ID #: 2018-1526
• Secondary ID: 5K23HL130524-03
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 18, 2019
• Est. completion date: May 2022

Study information

• Verified date: April 2021
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: May 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 years or older;

2. Physician diagnosis of COPD;

3. Hospitalized as an inpatient, 23-hour observation, or clinical decision unit

4. Admitting respiratory conditions sensitive to the Centers for Medicare and Medicaid

Services Hospital Readmission Reduction Program as listed below:

• COPD exacerbation
• Asthma/COPD overlap
• Decompensated heart failure
• Pneumonia
• Chronic Airway Disease

Exclusion Criteria:

1. Physical inability to participate in a walking program;

2. Oxygen saturation <90% by pulse oximetry refractory to supplemental oxygen, or in a patient unable or unwilling to use supplemental oxygen;

3. Fall in the previous 6 months;

4. Resting electrocardiogram (ECG) with new ST changes or tachyarrhythmia;

5. Planned discharge home to hospice or to long term care facility/skilled nursing facility;

6. Life expectancy <3 months;

7. Medical contraindication to participating in a physical activity promotion program as determined by the inpatient treating clinician;

8. Unable to communicate in English;

9. Unable or declines to provide informed consent.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• PACE2 Intervention
Written educational materials regarding physical activity, telephone-based coaching to integrate physical activity in daily life activities and address barriers to attending pulmonary rehabilitation.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean daily step counts	change in mean daily step counts (averaged over 1 week) over time using repeated measures over the 12 weeks of the study.	12 weeks
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression	Change in T-score from baseline to week 12 (A negative change in score indicates less emotional distress - depression).	12 weeks
Secondary	PROMIS Emotional Distress - Anxiety	Change in T-score from baseline to week 12 (A negative change in score indicates less emotional distress - anxiety).	12 weeks
Secondary	PROMIS Fatigue	Change in T-score from baseline to week 12 (A negative change in score indicates less fatigue).	12 weeks
Secondary	PROMIS Physical function	Change in T-score from baseline to week 12 (A negative change in score indicates lower physical function).	12 weeks