Mindful Steps: Promoting Physical Activity
Mindful Steps: Coupling Technology and Mind-Body Exercise to Facilitate Physical Activity in Patients With Cardiopulmonary Disease
1 other identifier
interventional
42
1 country
1
Brief 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. The second phase will pilot test this new intervention in a longitudinal study (subjects randomized to intervention or usual care).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2016
CompletedFirst Posted
Study publicly available on registry
December 28, 2016
CompletedStudy Start
First participant enrolled
January 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2021
CompletedJanuary 9, 2023
January 1, 2023
2.5 years
December 13, 2016
January 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Feasibility
intervention acceptability (qualitative interview)
6 months
Secondary Outcomes (2)
Self-efficacy
baseline, months 3, 6, 9 and 12
Physical activity
baseline, months 3,6,9, and 12
Study Arms (2)
Mindful Steps
EXPERIMENTALWeb-based behavioral intervention
Usual Care
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BIDMC
Boston, Massachusetts, 02215, United States
Related Publications (2)
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.
PMID: 41147625DERIVEDLitrownik 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.
PMID: 33913819DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
December 13, 2016
First Posted
December 28, 2016
Study Start
January 2, 2019
Primary Completion
July 6, 2021
Study Completion
July 6, 2021
Last Updated
January 9, 2023
Record last verified: 2023-01