NCT04953806Active, not recruiting
The Development of an Integrated Physical Activity and Mental Health Intervention for Veterans With COPD, Emotion Distress, and Low Physical Activity
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
Chronic Obstructive Pulmonary Disease (COPD) is prevalent and debilitating chronic disease in Veterans. COPD is highly co-morbid with depression and anxiety conferring greater morbidity and mortality risk. Physical activity is a modifiable behavior that can improve COPD outcomes. However, to date, interventions targeting physical activity have not addressed the high comorbidity between COPD and depression and/or anxiety symptoms ("emotional distress") despite emotional distress predicting poorer response to physical activity interventions. This CDA-2 proposal will develop and test the acceptability and feasibility of an integrative physical activity and mental health intervention for Veterans with COPD, emotional distress, and low physical activity. The intervention will be delivered via VA Video Connect enabling access to care among Veterans with substantial barriers to hospital-based outpatient care.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 45 (actual)
- First submitted
- 24 Jun 2021
- Start date
- 2 Nov 2021
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- VA Office of Research and Development
- Diseases
- COPD
- NCT number
- NCT04953806
What you commit to
- Study type: Interventional
- Participants enrolled: 45
- From 2 Nov 2021 to the primary completion date, 31 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- COPD exacerbation in the previous 1 month
Other illness
- Positive screening on the Mini-Cog defined as \< 3 indicating possible cognitive impairment or dementia or major neurocognitive disorder diagnosis in electronic medical chart or refusal to complete the assessment
Lab values
- Inability to collect at least 4 valid days of 7-day baseline step count data
- Average baseline step counts of greater than or equal to 10,000 steps per week
Other
- Inability to ambulate
- Regular use of a rollator, walker, or wheelchair for ambulation
- Inability to complete questionnaires
- Currently enrolled in another interventional study targeting exercise, physical activity, or mental health
- Suicide flag in chart
- Oxygen saturation after 6-Minute Walk Test documented to be \<85%
Who the study is looking for
- Any gender-identified, greater than or equal to 40 years of age
- Clinical diagnosis of COPD defined as the presence of emphysema on a CT scan and one piece of clinical evidence of COPD (defined as a ratio of FEV1 to forced vital capacity \< 0.70, \> 10 pack-year cigarette smoking history, overall assessment of COPD in their problem list or in Pulmonary/Primary Care notes, or on bronchodilators (specifically antimuscarinics such as Tiotropium or Ipratropium). If there is no evidence of emphysema, or no CT on scan in their medical chart, three pieces of clinical evidence of COPD will suffice for a clinical diagnosis of COPD.
- Ability to communicate
- Able to participate in in-person study appointment at the VA
- English speaking
- Competent to provide informed consent
- Emotional distress. Clinically significant depression and/or anxiety defined as PHQ-8 \> 10 and/or Beck Anxiety Inventory \> 13
- Wireless Internet connection and Bluetooth capability
- Participants with \> 90% accuracy of device Fitbit to manual step counts
- Agreeable to audio record study session
- Agreeable to wearing an ActiGraphy device and Fitbit and downloading the Fitbit app
- Email user for VVC visits links
- Either owns a smartphone or iPad compatible with the Fitbit app and enabled with Bluetooth or agreeable to using a study-issued iPad with Wi-Fi and Bluetooth capabilities
- Medical clearance from healthcare provider to participate in a physical activity program
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.