NCT05934565 · Beth Israel Deaconess Medical Center
Mindful Steps 2.0: Promoting Physical Activity in Patients With COPD and HF
What this study is about
The goal of this fully-remote randomly assigned controlled trial is to test the effectiveness of Mindful Steps in facilitating physical activity compared to usual the usual treatment 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 28, 2025 · Source of record for eligibility and locations