Mindful Steps for COPD and Heart Failure

Recruiting at 1 trial location

Overseen By Gloria Yeh

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Copd, Hf exacerbation, Inability to ambulate, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: 12 months

136 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a program called Mindful Steps can help individuals with COPD (a lung disease that makes breathing difficult) or heart failure (when the heart doesn't pump blood effectively) become more active. Participants will either follow the Mindful Steps plan, which includes tools like a pedometer, online classes, and motivational content, or continue with their usual care. Researchers aim to determine if Mindful Steps increases daily step counts compared to standard care. This trial may suit those with COPD or heart failure who have their doctor's approval to join an exercise program, are not in a rehab program, and can use a smartphone or computer.

As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance activity levels and quality of life for those with COPD or heart failure.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Mindful Steps intervention is safe for patients with COPD and/or heart failure?

Research has shown that Mindful Steps is generally safe for people with COPD (chronic obstructive pulmonary disease) and heart failure. In a previous study, participants using Mindful Steps did not report any major safety issues. This program includes tools like a step counter, motivational content, and online exercise classes, all designed to safely increase physical activity.

The program combines exercises that connect the mind and body with educational content, which earlier studies have well-received. As a digital program without invasive procedures, Mindful Steps carries fewer risks than traditional medical treatments. Participants have used the program safely, with no serious side effects reported.

While researchers continue to study Mindful Steps, early findings suggest it is a safe way to encourage more movement in people with these conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mindful Steps for COPD and heart failure because this innovative approach combines physical activity with mind-body practices, all delivered through a convenient web platform. Unlike traditional treatments that rely mostly on medication and general advice for exercise, Mindful Steps offers a multi-modal strategy that includes personalized step-count goals, motivational videos, and online community support to encourage consistent activity. This holistic method not only aims to improve physical health but also addresses mental well-being, making it a comprehensive alternative to standard care.

What evidence suggests that the Mindful Steps intervention could be effective for increasing physical activity in patients with COPD and heart failure?

Research has shown that Mindful Steps, which participants in this trial may receive, can help individuals with COPD and heart failure become more active. In a previous study, participants using Mindful Steps walked more each day compared to those receiving usual care. The program employs tools like step counters and online support to motivate and guide users. It also offers online classes and videos to encourage regular movement. Although the program did not alter medication adherence or feelings of depression, it improved skills such as thinking, physical ability, and awareness. Overall, Mindful Steps appears promising in promoting increased activity and better health. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for patients with COPD or heart failure who can exercise, have an email and a device to use the Fitbit app. They need medical clearance and must not be in rehab or have had recent exacerbations.

Inclusion Criteria

I have been diagnosed with COPD or heart failure based on specific criteria.

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

I can't provide 2 weeks of my daily step counts.

I have had a worsening of my COPD or heart failure in the last month.

I am currently in a heart or lung rehab program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Mindful Steps intervention or usual care for 12 months

12 months

Remote assessments at baseline, 3, 6, 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Remote assessment at 15 months

What Are the Treatments Tested in This Trial?

Interventions

• Mindful Steps

Trial Overview The study tests Mindful Steps, aiming to increase physical activity over 12 months compared to usual care. Participants are randomly assigned to either the intervention or control group, both receiving a health booklet.

How Is the Trial Designed?

Group I: Mindful Steps Experimental Treatment 1 Intervention

Multi-modal web intervention including: pedometer with individualized step-count goals, motivational and educational content, online community forum, mind-body videos (short themed clips that support walking, plus library of mind-body exercises), online group mind-body exercise classes, star incentive system; educational booklet

Group II: Usual Care Active Control 1 Intervention

Pragmatic usual care (standard care through participant's healthcare provider including pharmacological treatment and general advice for physical activity); educational booklet

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

VA Boston Healthcare System

Collaborator

Trials

73

Recruited

971,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Published Research Related to This Trial

The Mindful Steps intervention, which combines mind-body techniques with self-regulatory components, positively influenced walking behaviors in individuals with COPD and heart failure, as reported by participants in qualitative interviews.

Participants found components like pedometer feedback and group classes helpful, and many continued to use the strategies learned, indicating potential long-term benefits for physical and mental health, although some noted limited impact on their walking or health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Mind-Body Intervention (Mindful Steps) for Promoting Walking in Chronic Cardiopulmonary Disease: Insights From a Qualitative Study. Kraemer, KM., Kilgore, K., Litrownik, D., et al.[2023]

A pilot project involving 11 patients recently discharged from heart failure hospitalization showed that integrative group medical visits combined with mindfulness training are feasible, with 73% of participants attending at least 4 out of 8 sessions.

After the program, all patients expressed intentions to improve their diet, exercise, and stress management, and notable improvements were observed in depression, fatigue, and life satisfaction, suggesting potential benefits for CHF management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative Medical Care Plus Mindfulness Training for Patients With Congestive Heart Failure: Proof of Concept. Kemper, KJ., Carmin, C., Mehta, B., et al.[2017]

Mindfulness training (MT) delivered via phone was found to be feasible and well-accepted by participants, with a 100% retention rate and 91% attendance over 8 weeks among 33 outpatients with heart failure.

While MT did not improve medication adherence or depression levels, it significantly enhanced cognitive function, functional capacity, and mindfulness skills, indicating potential benefits for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind Your Heart: Exploring Feasibility, Acceptability, and Preliminary Effects of Phone-Delivered Mindfulness Training on Medication Adherence in Outpatients With Chronic Heart Failure. Salmoirago-Blotcher, E., Walaska, K., Trivedi, D., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8120426/

Development of a Novel Intervention (Mindful Steps) to ... This study aims to develop a novel multimodal mind–body exercise intervention through adaptation of an existing web-based physical activity intervention.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05934565

Mindful Steps 2.0: Promoting Physical Activity in Patients ... Physical activity as measured by pedometer (i.e., daily step counts) at 12 months is the primary outcome to assess the efficacy of the Mindful Steps ...

3. formative.jmir.org formative.jmir.org/2025/1/e74118

Promoting Walking in Cardiopulmonary Disease With Mindful ... Methods: In this pilot randomized controlled trial, participants with chronic, stable HF and COPD were randomized to Mindful Steps or usual care ...

4. trialx.com trialx.com/clinical-trials/listings/318491/mindful-steps-20-promoting-physical-activity-in-patients-with-copd-and-hf/

Promoting Physical Activity in Patients With COPD and HF The goal of this fully-remote randomized controlled trial is to test the efficacy of Mindful Steps in facilitating physical activity compared to ...

5. withpower.com withpower.com/trial/phase-pulmonary-disease-chronic-obstructive-5-2024-b619f

Mindful Steps for COPD and Heart Failure While MT did not improve medication adherence or depression levels, it significantly enhanced cognitive function, functional capacity, and mindfulness skills, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10693791/

A Web-Based Mind-Body Intervention (Mindful Steps) for ... Mindful Steps, designed to promote walking behaviors in COPD and HF, is a multicomponent intervention that integrates mind-body content with other self- ...