CopdNCT03003780
Mindful Steps: Promoting Physical Activity
A study testing Mindful Steps in people with Copd and Heart Failure, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This is a developmental project with two phases. The first phase will adapt an existing web-based intervention to incorporate mind-body exercises to develop a multi-modal intervention to promote physical activity in patients with COPD and HF. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Copd, 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
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2019to 6 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 OR clinical diagnosis of HF syndrome (New York Heart Association Class 1-3)
- Able to participate in an exercise program
- Have an active email account and access to a computer with internet connection
Who cannot join
- COPD or HF exacerbation in the previous month
- Inability to ambulate
- Clinical signs of unstable cardiovascular disease
- Hypoxemia during 6MWT
- 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
1 site in 1 country.
About this study
Official title: Mindful Steps: Coupling Technology and Mind-Body Exercise to Facilitate Physical Activity in Patients With Cardiopulmonary Disease
This is a developmental project with two phases. The first phase will adapt an existing web-based intervention to incorporate mind-body exercises to develop a multi-modal intervention to promote physical activity in patients with COPD and HF. The second phase will pilot test this new intervention in a longitudinal study (subjects randomized to intervention or usual care).
- Conditions
- Copd, Heart Failure
- Being tested
- Mindful Steps
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure
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 | Web-based behavioral intervention Receives: Behavioral: Mindful Steps |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
intervention acceptability (qualitative interview)
Measured: 6 months
Secondary outcomes (2)
Self-efficacy
change in self-efficacy between time points (exercise self-efficacy scale)
Measured: baseline, months 3, 6, 9 and 12
Physical activity
change in physical activity between time points (physical activity questionnaire)
Measured: baseline, months 3,6,9, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study start2 Jan 2019
- Primary completion6 Jul 2021
- Study completion6 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gloria Y. Yeh, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003780
- Sponsor's protocol ID
- 2016P000368
- Status last verified
- Jan 2023
- First submitted
- 13 Dec 2016
- Last updated
- 9 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kraemer KM, Litrownik D, Wayne PM, Richardson CR, Bhomia N, Kadri R, Rist PM, Ngo L, Moy ML, Yeh GY. Promoting Walking in Cardiopulmonary Disease With Mindful Steps: Pilot Feasibility Randomized Controlled Trial of a Web-Based, Pedometer-Mediated Mind-Body Intervention. JMIR Form Res. 2025 Oct 28;9:e74118. doi: 10.2196/74118.
PubMed 41147625Litrownik D, Gilliam EA, Wayne PM, Richardson CR, Kadri R, Rist PM, Moy ML, Yeh GY. Development of a Novel Intervention (Mindful Steps) to Promote Long-Term Walking Behavior in Chronic Cardiopulmonary Disease: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Apr 29;10(4):e27826. doi: 10.2196/27826.
PubMed 33913819
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. 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 Patients With Cardiopulmonary Disease
- ClinicalTrials.gov ID
- NCT03003780
- Acronym / sponsor ID
- 2016P000368
- Conditions
- Copd, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 6 Jul 2021 (actual)
- Study completion
- 6 Jul 2021 (actual)
- First posted
- 28 Dec 2016 (estimated)
- 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.
This is a developmental project with two phases. The first phase will adapt an existing web-based intervention to incorporate mind-body exercises to develop a multi-modal intervention to promote physical activity in patients with COPD and HF. The second phase will pilot test this new intervention in a longitudinal study (subjects randomized to intervention or usual care).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Steps | Experimental | Behavioral: Mindful StepsWeb-based behavioral intervention |
| Usual Care | No intervention | – |
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 OR clinical diagnosis of HF syndrome (New York Heart Association Class 1-3)
- Able to participate in an exercise program
- Have an active email account and access to a computer with internet connection
Key exclusion criteria (6 listed)
- COPD or HF exacerbation in the previous month
- Inability to ambulate
- Clinical signs of unstable cardiovascular disease
- Hypoxemia during 6MWT
- Inability to collect at least 7 of 14 days of baseline step counts
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
Feasibility
Time frame: 6 months
intervention acceptability (qualitative interview)
2 secondary outcomes
Self-efficacy
Time frame: baseline, months 3, 6, 9 and 12
Physical activity
Time frame: baseline, months 3,6,9, and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Derived from this study: PubMed 41147625Kraemer KM, Litrownik D, Wayne PM, Richardson CR, Bhomia N, Kadri R, Rist PM, Ngo L, Moy ML, Yeh GY. Promoting Walking in Cardiopulmonary Disease With Mindful Steps: Pilot Feasibility Randomized Controlled Trial of a Web-Based, Pedometer-Mediated Mind-Body Intervention. JMIR Form Res. 2025 Oct 28;9:e74118. doi: 10.2196/74118.
- Derived from this study: PubMed 33913819Litrownik D, Gilliam EA, Wayne PM, Richardson CR, Kadri R, Rist PM, Moy ML, Yeh GY. Development of a Novel Intervention (Mindful Steps) to Promote Long-Term Walking Behavior in Chronic Cardiopulmonary Disease: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Apr 29;10(4):e27826. doi: 10.2196/27826.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Copd and Heart Failure, run by Beth Israel Deaconess Medical Center at 1 site 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 6 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: finished, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03003780, which also lists 2 linked publications.
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 9 Jan 2023.