NCT05934565 Mindful Steps 2.0: Promoting Physical Activity in Patients With COPD and HF
| NCT ID | NCT05934565 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beth Israel Deaconess Medical Center |
| Condition | Chronic Obstructive Pulmonary Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2025-04-28 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 136 participants in total. It began in 2025-04-28 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05934565 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Chronic Obstructive Pulmonary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05934565 currently recruiting?
Yes, NCT05934565 is actively recruiting participants. Contact the research team at gyeh@bidmc.harvard.edu for enrollment information.
Where is the NCT05934565 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States.
Who is sponsoring the NCT05934565 clinical trial?
NCT05934565 is sponsored by Beth Israel Deaconess Medical Center. The trial plans to enroll 136 participants.