Promoting physical activity in patients with COPD and heart failure
Official title: Mindful Steps: Coupling Technology and Mind-Body Exercise to Facilitate Physical Activity in Chronic Cardiopulmonary Disease
Run by Beth Israel Deaconess Medical Center · NCT05934565 · Data updated 2026-11-12
This study is testing if a new program called Mindful Steps can help people with COPD and heart failure be more active by tracking their daily steps for a year.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 136 (estimated) |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Status | Recruiting |
| Started | April 28, 2025 |
| Main results expected | June 30, 2028 |
| Study ends | June 30, 2028 |
| Registry record updated | September 29, 2026 |
| Trial ID | NCT05934565 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals diagnosed with COPD or HF who have medical clearance to participate in an exercise program and have access to technology for remote monitoring.
✕Probably not a fit
Patients experiencing recent exacerbations of COPD or HF, those unable to ambulate, or currently enrolled in rehabilitation programs may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial aims to evaluate the effectiveness of the Mindful Steps intervention in increasing physical activity among patients with Chronic Obstructive Pulmonary Disease (COPD) and Chronic Heart Failure (HF). A total of 136 participants will be randomly assigned to either the Mindful Steps program or standard care, which includes an educational booklet on walking, for a duration of 12 months. The primary outcome will be measured through daily step counts using a pedometer, with additional assessments of cognitive-behavioral factors and patient-centered clinical outcomes at various time points. The study is fully remote, allowing participants to engage from home.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance physical activity levels and overall quality of life for patients with COPD and HF.
How similar studies have gone: Previous studies have shown promise in using technology-based interventions to promote physical activity in similar patient populations, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of COPD (defined as cigarette smoking history \> 10 pack-years, and either a ratio of FEV1 to forced vital capacity \< 0.70 or chest CT evidence of emphysema) OR clinical diagnosis of HF syndrome (with left ventricular systolic dysfunction or preserved ejection fraction and New York Heart Association Class 1-3) * Medical clearance from provider to participate in an exercise program * Have an active email account; access to a computer device (desktop, laptop, tablet, or smartphone that supports the Fitbit app). Exclusion Criteria: * COPD or HF exacerbation in the previous month * Inability to ambulate * Inability to collect at least 7 of 14 days of baseline step counts * Current participation in a cardiac or pulmonary rehabilitation program
Where it's running
-
VA Boston
Boston, Massachusetts, United States Recruiting -
Bidmc
Boston, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Gloria Yeh
- Email: gyeh@bidmc.harvard.edu
- Phone: (617) 667-2845
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.