Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05934565

Mindful Steps 2.0: 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 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Chronic Heart Failure Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BIDMC, Boston, Massachusetts, United States

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindful Steps

Behavioral

Integrated website, activity tracker, and mind-body training

Primary outcomes

  1. Change in physical activity

    Time frame: baseline, months 3, 6, 12, and 15

    Daily step counts will be measured as an objective proxy for physical activity using FitBit pedometers (FitBit Inspire 3)

Secondary outcomes

  1. Change in self-efficacy

    Time frame: baseline, months 3, 6, 12, and 15

    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.

  2. Change in intrinsic motivation

    Time frame: baseline, months 3, 6, 12, and 15

    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.

  3. Qualitative inquiry

    Time frame: months 6 and 12

    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.

  4. Change in disease-specific quality-of-life

    Time frame: baseline, months 3, 6, 12, and 15

    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.

  5. Change in exercise engagement

    Time frame: baseline, months 3, 6, 12, and 15

    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.

  6. Change in sedentary behaviors/time

    Time frame: baseline, months 3, 6, 12, and 15

    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.

  7. Change in dyspnea

    Time frame: baseline, months 3, 6, 12, and 15

    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.

  8. Change in fatigue

    Time frame: baseline, months 3, 6, 12 and 15

    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.

  9. Change in mindful awareness

    Time frame: baseline, months 3, 6, 12 and 15

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gloria Yeh

CONTACT

[email protected]

(617) 667-2845

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Brigham and Women's Hospital
  • University of Michigan
  • VA Boston Healthcare System

Registry information

Official study title

Mindful Steps: Coupling Technology and Mind-Body Exercise to Facilitate Physical Activity in Chronic Cardiopulmonary Disease

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 7, 2023
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.