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NCT05934565 | NOT YET RECRUITING | Chronic Obstructive Pulmonary Disease

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

Beth Israel Deaconess Medical Center

Information provided by (Responsible Party):

Gloria Y. Yeh

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.

Condition or disease

Chronic Obstructive Pulmonary Disease

Chronic Heart Failure

Intervention/treatment

Mindful Steps

Phase

NA

Detailed Description:

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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 136 participants
Masking : SINGLE
Masking Description : Testing will be facilitated by study staff who are blinded to treatment assignment.
Primary Purpose : TREATMENT
Official Title : Mindful Steps: Coupling Technology and Mind-Body Exercise to Facilitate Physical Activity in Chronic Cardiopulmonary Disease
Actual Study Start Date : 2025-02-28
Estimated Primary Completion Date : 2028-06-30
Estimated Study Completion Date : 2028-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Mindful Steps 2.0: Promoting Physical Activity in Patients With COPD and HF

Location Details

NCT05934565

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How to Participate

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Locations

Not yet recruiting

United States, Massachusetts

BIDMC

Boston, Massachusetts, United States, 02215