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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease; Chronic Heart Failure
• Intervention / Treatment: Behavioral: Mindful Steps

Detailed Description

This is a 2-arm parallel remotely delivered RCT. A total of 136 participants with COPD and/or HF will be randomized in a 1:1 ratio to one of 2 arms in a pragmatic design: 1) Mindful Steps multi-modal intervention, or 2) usual care (including an education booklet on walking). Subjects will participate in the intervention for 12 months. Testing will occur at baseline, 3, 6, 12 (end intervention), and 15 months (post-intervention follow up) for all participants. 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 intervention. Secondary outcomes include cognitive-behavioral measures that may relate to behavior change in a conceptual model (self-efficacy, intrinsic motivation, mindful awareness/interoception) as well as patient-centered clinical outcomes (HRQL, dyspnea, fatigue, PA engagement, sedentary behavior).

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gloria Yeh; Phone Number: (617) 667-2845; Email: gyeh@bidmc.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • BIDMC
    • Boston, Massachusetts, United States, 02132
      • Recruiting
      • VA Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindful Steps; 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	Behavioral: Mindful Steps; Integrated website, activity tracker, and mind-body training
No Intervention: Usual Care; Pragmatic usual care (standard care through participant's healthcare provider including pharmacological treatment and general advice for physical activity); educational booklet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical activity	Daily step counts will be measured as an objective proxy for physical activity using FitBit pedometers (FitBit Inspire 3)	baseline, months 3, 6, 12, and 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-efficacy	Exercise self-efficacy will be measured using the Self-Efficacy for Exercise Scale and the Self-Efficacy for Managing Chronic Disease Scale. The Self-Efficacy for Exercise Scale a 9-item validated scale; scores range from 9-28, with a higher score meaning more self-efficacy. The Self-Efficacy for Managing Chronic Disease Scale is a 6-item visual analog scale; scores range from 1-10, with a higher score indicating higher self-efficacy.	baseline, months 3, 6, 12, and 15
Change in intrinsic motivation	Intrinsic motivation will be measured using the Intrinsic Motivation Inventory. This is a 22-item scale validated with four sub-scales: interest/enjoyment, perceived competence, perceived choice, and pressure/tension. A higher score is better, with a scoring range of 22-154.	baseline, months 3, 6, 12, and 15
Qualitative inquiry	Half-hour semi-structured qualitative interviews guided by study staff will be conducted over video/phone in a random subset of 50 participants at the 6 and 12 month timepoints.	months 6 and 12
Change in disease-specific quality-of-life	Disease-specific quality-of-life will be measured using St. George's Respiratory Questionnaire (SGRQ) and The Minnesota Living with Heart Failure Questionnaire (MLFHQ). The SGRQ is a 50-item instrument developed and validated in COPD and calculates four scores: symptomatology, activity, impacts and an overall metric; scores range from 0-100, with higher scores indicating more limitations. The MLFHQ is a 21-item instrument; total scores range from 0-105, with higher scores indicating poorer quality-of-life.	baseline, months 3, 6, 12, and 15
Change in exercise engagement	Exercise engagement will be measured using the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire. This 41-item self-report questionnaire assesses engagement with physical activity, including frequency and duration, among older adults over the past 4 weeks. Separate scores are derived for physical activities of varying intensities. Frequency and estimated caloric expenditure are calculated per week for each of these physical activity categories, with higher scores indicating greater frequency and duration of exercise.	baseline, months 3, 6, 12, and 15
Change in sedentary behaviors/time	Sedentary behaviors/time will be measured using online weekly exercise logs. These online weekly exercise logs will be used to assess frequency and categorize exercises.	baseline, months 3, 6, 12, and 15
Change in dyspnea	Dyspnea is being measured using the UCSD Shortness of Breath Questionnaire - a 24 item questionnaire using a 6 point Likert scale; scores range from 0-120, with higher scores indicating greater dyspnea.	baseline, months 3, 6, 12, and 15
Change in fatigue	Fatigue will be measured using the The Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 7a. Raw scores range from 7-35, and each raw score is translated into a standardized T-score, with higher T-scores representing greater fatigue.	baseline, months 3, 6, 12 and 15
Change in mindful awareness	Mindful awareness will be measures using the Multidimensional Assessment of Interoceptive Awareness, consisting of 37 items (8 domains), each domain scored as the average score on a 6-point Likert.	baseline, months 3, 6, 12 and 15

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: University of Michigan; Brigham and Women's Hospital; VA Boston Healthcare System

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: June 28, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Mind-Body Exercise; FitBit; Mindful Steps
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: R01AT012166-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No