Chronic Obstructive Pulmonary DiseaseNCT05934565
Mindful Steps 2.0: Promoting Physical Activity in Patients With COPD and HF
A study testing Mindful Steps in people with Chronic Obstructive Pulmonary Disease and Chronic Heart Failure, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Chronic Heart Failure
- What is being tested?
- Mindful Steps
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Apr 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
VA Boston
Boston, Massachusetts, 02132
- Recruiting
BIDMC
Boston, Massachusetts, 02215
About this study
Official title: 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.
Read the 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).
- Being tested
- Mindful Steps
- Keywords
- Mind-Body Exercise, FitBit, Mindful Steps
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful StepsBehavioural
Integrated website, activity tracker, and mind-body training
| Study group | Role | What they receive |
|---|---|---|
| Mindful Steps | Experimental | 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 Receives: Behavioral: Mindful Steps |
| Usual Care | No intervention | Pragmatic usual care (standard care through participant's healthcare provider including pharmacological treatment and general advice for physical activity); educational booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity
Daily step counts will be measured as an objective proxy for physical activity using FitBit pedometers (FitBit Inspire 3)
Measured: baseline, months 3, 6, 12, and 15
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, months 3, 6, 12 and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start28 Apr 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm parallel remotely delivered randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, VA Boston Healthcare System, University of Michigan
- Responsible party
- Principal investigator, Gloria Y. Yeh, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934565
- Sponsor's protocol ID
- R01AT012166-01A1
- Status last verified
- Sep 2026
- First submitted
- 22 Jun 2023
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Steps: Coupling Technology and Mind-Body Exercise to Facilitate Physical Activity in Chronic Cardiopulmonary Disease
- ClinicalTrials.gov ID
- NCT05934565
- Acronym / sponsor ID
- R01AT012166-01A1
- Keywords
- Mind-Body Exercise, FitBit, Mindful Steps
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, VA Boston Healthcare System, University of Michigan
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2-arm parallel remotely delivered randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Mindful Steps | Experimental | Behavioral: Mindful StepsMulti-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 |
| Usual Care | No intervention | –Pragmatic usual care (standard care through participant's healthcare provider including pharmacological treatment and general advice for physical activity); educational booklet |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful StepsIntegrated website, activity tracker, and mind-body training | Behavioural | Mindful Steps |
Primary outcome
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)
9 secondary outcomes
Change in self-efficacy
Time frame: baseline, months 3, 6, 12, and 15
Change in intrinsic motivation
Time frame: baseline, months 3, 6, 12, and 15
Qualitative inquiry
Time frame: months 6 and 12
Change in disease-specific quality-of-life
Time frame: baseline, months 3, 6, 12, and 15
Change in exercise engagement
Time frame: baseline, months 3, 6, 12, and 15
Change in sedentary behaviors/time
Time frame: baseline, months 3, 6, 12, and 15
Change in dyspnea
Time frame: baseline, months 3, 6, 12, and 15
Change in fatigue
Time frame: baseline, months 3, 6, 12 and 15
Change in mindful awareness
Time frame: baseline, months 3, 6, 12 and 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Steps in people with Chronic Obstructive Pulmonary Disease and Chronic Heart Failure, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gloria Yeh ((617) 667-2845, gyeh@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical activity (time frame: baseline, months 3, 6, 12, and 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.