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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Mindful Steps for COPD and Heart Failure?

Mindful Steps is designed to help people with COPD and heart failure become more active by promoting walking through a combination of mind-body techniques and self-regulation strategies. Similar mindfulness-based programs have shown benefits in increasing physical activity and improving overall well-being, suggesting that Mindful Steps could be effective in encouraging long-term walking behavior. ^{1 2 3 4 5}

Is the Mindful Steps intervention safe for humans?

The available research does not specifically address the safety of the Mindful Steps intervention, but it is a mind-body program designed to promote walking, which is generally considered safe for most people with chronic conditions like COPD and heart failure. ^{1 2 3 6 7}

How is the Mindful Steps treatment different from other treatments for COPD and heart failure?

Mindful Steps is unique because it combines mind-body techniques with self-regulation strategies to encourage long-term walking habits in people with COPD and heart failure, using a web-based platform to make it accessible and sustainable. ^{1 2 3 6 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States 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. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

Development of a Novel Intervention (Mindful Steps) to Promote Long-Term Walking Behavior in Chronic Cardiopulmonary Disease: Protocol for a Randomized Controlled Trial. [2021]

3. United States 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A comprehensive care management program to prevent chronic obstructive pulmonary disease hospitalizations: a randomized, controlled trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Mindfulness and motivational interviewing: two candidate methods for promoting self-management. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Perspectives of healthcare professionals and patients on the application of mindfulness in individuals with chronic obstructive pulmonary disease. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Walking and mindfulness improve the exercise capacity of patients with chronic obstructive pulmonary disease: A randomised controlled trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Integrative Medical Care Plus Mindfulness Training for Patients With Congestive Heart Failure: Proof of Concept. [2017]