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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Subjects will participate in the intervention for 12 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether Mindful Steps helps people who are not very active walk more each day. It is for people with COPD, a long-term lung disease, and/or heart failure (HF), a condition where the heart does not pump blood well. The study is fully remote, lasts 12 months, and assigns people by chance to Mindful Steps or usual care; both groups get a walking guide.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have COPD or heart failure diagnosed by a health care provider and meet the study’s requirements below for that condition.
  • For COPD: have smoked more than 10 pack-years (for example, 1 pack a day for more than 10 years), plus a breathing test ratio below 0.70 or a chest CT scan showing emphysema (lung damage).
  • For heart failure: have reduced heart pumping strength or heart failure with normal pumping strength, and New York Heart Association class 1–3 symptoms.
  • Have approval from your health care provider to join an exercise program.
  • Have an active email account and access to a computer, tablet, or smartphone that supports the Fitbit app.

Who can't join

  • Had a COPD or heart failure flare-up in the past month.
  • Cannot walk.
  • Cannot record starting daily step counts for at least 7 out of 14 days.
  • Are currently in a heart or lung rehabilitation program, which helps people improve their health and activity.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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

Study sites (2)

MA