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Mindful Steps 2.0: Promoting Physical Activity in Patients With COPD and HF
NCT05934565 · Beth Israel Deaconess Medical Center
In plain English
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Official title
Mindful Steps: Coupling Technology and Mind-Body Exercise to Facilitate Physical Activity in Chronic Cardiopulmonary Disease
About this study
This is a 2-arm parallel remotely delivered RCT. A total of 136 participants with COPD and/or HF will be randomized in a 1:1 ratio to one of 2 arms in a pragmatic design: 1) Mindful Steps multi-modal intervention, or 2) usual care (including an education booklet on walking). Subjects will participate in the intervention for 12 months. Testing will occur at baseline, 3, 6, 12 (end intervention), and 15 months (post-intervention follow up) for all participants. Physical activity as measured by pedometer (i.e., daily step counts) at 12 months is the primary outcome to assess the efficacy of the Mindful Steps intervention. Secondary outcomes include cognitive-behavioral measures that may relate to behavior change in a conceptual model (self-efficacy, intrinsic motivation, mindful awareness/interoception) as well as patient-centered clinical outcomes (HRQL, dyspnea, fatigue, PA engagement, sedentary behavior).
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
Study design
Enrollment target: 136 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-04-28
Estimated completion: 2028-06-30
Last updated: 2025-05-28
Interventions
Behavioral: Mindful Steps
Primary outcomes
- • Change in physical activity (baseline, months 3, 6, 12, and 15)
Sponsor
Beth Israel Deaconess Medical Center · other
With: Brigham and Women's Hospital, VA Boston Healthcare System, University of Michigan
Contacts & investigators
ContactGloria Yeh · contact · gyeh@bidmc.harvard.edu · (617) 667-2845
All locations (2)
VA BostonRecruiting
Boston, Massachusetts, United States
BIDMCRecruiting
Boston, Massachusetts, United States