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Mindful Steps: Promoting Physical Activity

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ClinicalTrials.gov Identifier: NCT03003780
Recruitment Status : Completed
First Posted : December 28, 2016
Last Update Posted : January 9, 2023
Sponsor:
Information provided by (Responsible Party):
Gloria Y. Yeh, Beth Israel Deaconess Medical Center

Study Description
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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).

Condition or disease Intervention/treatment Phase
Copd Heart Failure Behavioral: Mindful Steps Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindful Steps: Coupling Technology and Mind-Body Exercise to Facilitate Physical Activity in Patients With Cardiopulmonary Disease
Actual Study Start Date : January 2, 2019
Actual Primary Completion Date : July 6, 2021
Actual Study Completion Date : July 6, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Mindful Steps
Web-based behavioral intervention
 Behavioral: Mindful Steps
Integrated website, activity tracker, and mind-body training
No Intervention: Usual Care


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility [ Time Frame: 6 months ]
    intervention acceptability (qualitative interview)


Secondary Outcome Measures :
  1. Self-efficacy [ Time Frame: baseline, months 3, 6, 9 and 12 ]
    change in self-efficacy between time points (exercise self-efficacy scale)

  2. Physical activity [ Time Frame: baseline, months 3,6,9, and 12 ]
    change in physical activity between time points (physical activity questionnaire)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003780


Locations
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United States, Massachusetts
BIDMC
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gloria Y. Yeh, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03003780    
Other Study ID Numbers: 2016P000368
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: January 9, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases