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Recruiting
NCT05934565
Mindful Steps 2.0: Promoting Physical Activity in Patients With COPD and HF
Conditions: Chronic Obstructive Pulmonary Disease, Chronic Heart Failure
Sex: All
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 136
Sponsor: Beth Israel Deaconess Medical Center
Location: VA Boston Boston Massachusetts
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
Source: ClinicalTrials.gov (NCT05934565). StuddyBuddy aggregates publicly available trial information.