Promoting physical activity in patients with COPD and heart failure
Mindful Steps: Coupling Technology and Mind-Body Exercise to Facilitate Physical Activity in Chronic Cardiopulmonary Disease
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05934565 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Boston, Massachusetts and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.