NCT05934565

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Chronic Obstructive Pulmonary Disease
• Chronic Heart Failure

Interventions

Type	Name	Description
BEHAVIORAL	Mindful Steps	Integrated website, activity tracker, and mind-body training

Timeline

• Start date: 2025-04-28
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2023-07-07
• Last updated: 2025-05-28

Locations

2 sites across 1 country: United States