Mindful Steps: Promoting Physical Activity
Primary Purpose
Copd, Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindful Steps
Sponsored by
About this trial
This is an interventional treatment trial for Copd
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- BIDMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindful Steps
Usual Care
Arm Description
Web-based behavioral intervention
Outcomes
Primary Outcome Measures
Feasibility
intervention acceptability (qualitative interview)
Secondary Outcome Measures
Self-efficacy
change in self-efficacy between time points (exercise self-efficacy scale)
Physical activity
change in physical activity between time points (physical activity questionnaire)
Full Information
NCT ID
NCT03003780
First Posted
December 13, 2016
Last Updated
January 6, 2023
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03003780
Brief Title
Mindful Steps: Promoting Physical Activity
Official Title
Mindful Steps: Coupling Technology and Mind-Body Exercise to Facilitate Physical Activity in Patients With Cardiopulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
July 6, 2021 (Actual)
Study Completion Date
July 6, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Copd, Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindful Steps
Arm Type
Experimental
Arm Description
Web-based behavioral intervention
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Mindful Steps
Intervention Description
Integrated website, activity tracker, and mind-body training
Primary Outcome Measure Information:
Title
Feasibility
Description
intervention acceptability (qualitative interview)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Self-efficacy
Description
change in self-efficacy between time points (exercise self-efficacy scale)
Time Frame
baseline, months 3, 6, 9 and 12
Title
Physical activity
Description
change in physical activity between time points (physical activity questionnaire)
Time Frame
baseline, months 3,6,9, and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Facility Information:
Facility Name
BIDMC
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33913819
Citation
Litrownik 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.
Results Reference
derived
Learn more about this trial
Mindful Steps: Promoting Physical Activity
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