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NCT05934565From ClinicalTrials.govRecruiting

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

  • Chronic Obstructive Pulmonary Disease
  • Chronic Heart Failure

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Beth Israel Deaconess Medical Center
Enrolment target
136
Started
28 April 2025
Main results due
30 June 2028
Study sites
2
Registry updated
29 September 2026

Can you take part?

  • Aged 40 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(2)

  • VA Boston

    Boston, Massachusetts, United States

    Recruiting

  • BIDMC

    Boston, Massachusetts, United States

    Recruiting

Showing 2 of 2 sites. 2 of the 2 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05934565. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Mindful Steps 2.0: Promoting Physical Activity in Patients With COPD and HF | Trialion