Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
NCT05934565

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

Led by Beth Israel Deaconess Medical Center · Updated on 2025-05-28

136

Participants Needed

2

Research Sites

165 weeks

Total Duration

On this page

Sponsors

B

Beth Israel Deaconess Medical Center

Lead Sponsor

B

Brigham and Women's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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).
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

VA Boston

Boston, Massachusetts, United States, 02132

Actively Recruiting

2

BIDMC

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

G

Gloria Yeh

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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