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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Beth Israel Deaconess Medical Center • ClinicalTrials.gov ID: NCT05934565

Registry updated: 2026-09-29
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Description

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.

Interventions

  • Mindful Steps (Behavioral)
    Integrated website, activity tracker, and mind-body training

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

Conditions

Chronic Obstructive Pulmonary Disease Chronic Heart Failure

Locations

  • VA Boston — Boston, Massachusetts, United States
  • BIDMC — Boston, Massachusetts, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record