NCT05934565Recruiting
Mindful Steps 2.0: Promoting Physical Activity in Patients With COPD and HF
Mindful Steps: Coupling Technology and Mind-Body Exercise to Facilitate Physical Activity in Chronic Cardiopulmonary Disease
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
The goal of this fully-remote randomized controlled trial is to test the efficacy of Mindful Steps in facilitating physical activity compared to usual standard of care among 136 patients with COPD and/or HF. The main question it aims to answer is can this intervention promote physical activity as measured by daily step counts in sedentary patients with COPD and/or HF. Participants will be randomized (1:1 ratio) to receive either the Mindful Steps intervention or usual care for 12 months, with both arms receiving a Walking for Health education booklet.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 136 (estimated)
- First submitted
- 22 Jun 2023
- Start date
- 28 Apr 2025
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Diseases
- Heart failure, COPD
- NCT number
- NCT05934565
What you commit to
- Study type: Interventional
- Planned participants: 136
- From 28 Apr 2025 to the primary completion date, 30 Jun 2028
- 2 sites 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 or HF exacerbation in the previous month
Other illness
- Current participation in a cardiac or pulmonary rehabilitation program
Lab values
- Inability to collect at least 7 of 14 days of baseline step counts
Other
- Inability to ambulate
Who the study is looking for
- 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).
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VA Boston Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| BIDMC Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.