Chronic Obstructive Pulmonary DiseasePACE2NCT03793192
Promoting Activity After COPD Exacerbations, Aim 2
A study testing PACE2 Intervention in people with Chronic Obstructive Pulmonary Disease, run by University of Illinois at Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- PACE2 Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2019to 8 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older;
- Physician diagnosis of COPD;
- Hospitalized as an inpatient, 23-hour observation, or clinical decision unit
- Admitting respiratory conditions sensitive to the Centers for Medicare and Medicaid Services Hospital Readmission Reduction Program as listed below:
- COPD exacerbation
- Asthma/COPD overlap
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- Decompensated heart failure
- Pneumonia
- Chronic Airway Disease
Who cannot join
- Physical inability to participate in a walking program;
- Oxygen saturation <90% by pulse oximetry refractory to supplemental oxygen, or in a patient unable or unwilling to use supplemental oxygen;
- Fall in the previous 6 months;
- Resting electrocardiogram (ECG) with new ST changes or tachyarrhythmia;
- Planned discharge home to hospice or to long term care facility/skilled nursing facility;
- Life expectancy <3 months;
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- Medical contraindication to participating in a physical activity promotion program as determined by the inpatient treating clinician;
- Unable to communicate in English;
- Unable or declines to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: Promoting Activity After COPD Exacerbations, Aim 2 (PACE2)
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.
Read the 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
- Chronic Obstructive Pulmonary Disease
- Being tested
- PACE2 Intervention
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACE2 InterventionOther
Written educational materials regarding physical activity, telephone-based coaching to integrate physical activity in daily life activities and address barriers to attending pulmonary rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| PACE2 Intervention | Experimental | All participants will receive usual healthcare as per their treating medical team and carry a pedometer for recording of physical activity. In addition, participants randomized to the PACE2 intervention will receive written educational materials regarding physical activity, telephone-based coaching to integrate physical activity in daily life activities and address barriers to attending pulmonary rehabilitation. Receives: Other: PACE2 Intervention |
| Enhanced Usual Care | No intervention | All participants will receive usual healthcare as per their treating medical team and carry a pedometer for recording of physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (4)
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).
Measured: 12 weeks
PROMIS Emotional Distress - Anxiety
Change in T-score from baseline to week 12 (A negative change in score indicates less emotional distress - anxiety).
Measured: 12 weeks
PROMIS Fatigue
Change in T-score from baseline to week 12 (A negative change in score indicates less fatigue).
Measured: 12 weeks
PROMIS Physical function
Change in T-score from baseline to week 12 (A negative change in score indicates lower physical function).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start18 Mar 2019
- Primary completion8 Apr 2022
- Study completion8 Apr 2022
Why it stopped: PI leaving institution, data collected is insufficient for analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention versus Enhanced Usual Care
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jerry Krishnan, University of Illinois at Chicago
- Investigators
- Jerry Krishnan, MD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793192
- Sponsor's protocol ID
- 2018-1526
- Other IDs
- 5K23HL130524-03
- Acronym
- PACE2
- Status last verified
- Mar 2023
- First submitted
- 2 Jan 2019
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Activity After COPD Exacerbations, Aim 2 (PACE2)
- ClinicalTrials.gov ID
- NCT03793192
- Acronym / sponsor ID
- PACE2 / 2018-1526
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI leaving institution, data collected is insufficient for analysis
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 4 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention versus Enhanced Usual Care
| Arm | Type | Receives |
|---|---|---|
| PACE2 Intervention | Experimental | Other: PACE2 InterventionAll participants will receive usual healthcare as per their treating medical team and carry a pedometer for recording of physical activity. In addition, participants randomized to the PACE2 intervention will receive written educational materials regarding physical activity, telephone-based coaching to integrate physical activity in daily life activities and address barriers to attending pulmonary rehabilitation. |
| Enhanced Usual Care | No intervention | –All participants will receive usual healthcare as per their treating medical team and carry a pedometer for recording of physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years or older;
- Physician diagnosis of COPD;
- Hospitalized as an inpatient, 23-hour observation, or clinical decision unit
- Admitting respiratory conditions sensitive to the Centers for Medicare and Medicaid Services Hospital Readmission Reduction Program as listed below:
Key exclusion criteria (9 listed)
- Physical inability to participate in a walking program;
- Oxygen saturation <90% by pulse oximetry refractory to supplemental oxygen, or in a patient unable or unwilling to use supplemental oxygen;
- Fall in the previous 6 months;
- Resting electrocardiogram (ECG) with new ST changes or tachyarrhythmia;
- Planned discharge home to hospice or to long term care facility/skilled nursing facility;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PACE2 InterventionWritten educational materials regarding physical activity, telephone-based coaching to integrate physical activity in daily life activities and address barriers to attending pulmonary rehabilitation. | Other | PACE2 Intervention |
Primary outcome
Change in mean daily step counts
Time frame: 12 weeks
change in mean daily step counts (averaged over 1 week) over time using repeated measures over the 12 weeks of the study.
4 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression
Time frame: 12 weeks
PROMIS Emotional Distress - Anxiety
Time frame: 12 weeks
PROMIS Fatigue
Time frame: 12 weeks
PROMIS Physical function
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: PI leaving institution, data collected is insufficient for analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerry Krishnan, MD principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PACE2 Intervention in people with Chronic Obstructive Pulmonary Disease, run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI leaving institution, data collected is insufficient for analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean daily step counts (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.