No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
40 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
136 (estimated)
Sponsor
Beth Israel Deaconess Medical Center · Other
Who this trial is looking for
This trial is looking for patients with COPD or heart failure who want to be more active. Participants will be randomly assigned to use a program called Mindful Steps or receive usual care for 12 months to help increase their daily steps.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with COPD or heart failure.
I have medical clearance to take part in an exercise program.
I have an active email account.
I have access to a computer, tablet, or smartphone.
You may not be able to join if
I had a COPD or heart failure flare-up in the last month.
I cannot walk.
I cannot record at least 7 days of step counts before starting.
I am currently in a cardiac or pulmonary rehabilitation program.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 randomiz…
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.
Trial Locations
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Eligibility 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 eject…
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
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