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Mindful Steps 2.0 for Physical Activity in COPD and Heart Failure

This study is testing a program called Mindful Steps 2.0 to see if it helps people with Chronic Obstructive Pulmonary Disease (COPD) and/or Heart Failure (HF) become more physically active. Mindful Steps 2.0 includes a website, an activity tracker, and mind-body training. You could join if you are at least 40 years old, have a diagnosis of COPD or HF, and your doctor says you are medically cleared. The study aims to find out if Mindful Steps 2.0 can increase daily step counts compared to usual care. The study is currently unclear about its recruitment status and plans to enroll 136 participants.

Study design
This is a randomized controlled trial, meaning participants will be randomly assigned to either receive the Mindful Steps 2.0 program or usual care. There will be 136 participants in total.
What's involved
You would participate in the intervention for 12 months. Testing will occur at the beginning, and at 3, 6, 12, and 15 months.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 3 months after the 12-month intervention period, with a final assessment at 15 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05934565

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

Recruiting
NAAges 40+InterventionalTreatment
Beth Israel Deaconess Medical Center
~136 participants
Updated 2025-05-28 on ClinicalTrials.gov
What's tested:Mindful Steps

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in physical activity
Measured over baseline, months 3, 6, 12, and 15

Conditions

Chronic Obstructive Pulmonary Disease
Chronic Heart Failure

Explore related trials

Chronic heart failureChronic Obstructive Pulmonary Disease

Where it's being run

2 sites across 1 states
Massachusetts2

Who to contact

Gloria Yeh
[email protected]
(617) 667-2845
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in physical activitybaseline, months 3, 6, 12, and 15

    Daily step counts will be measured as an objective proxy for physical activity using FitBit pedometers (FitBit Inspire 3)