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Mindful Steps 2.0: Promoting Physical Activity in Patients With COPD and HF
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.
Conditions:
🦠 Chronic Obstructive Pulmonary Disease 🦠 Chronic Heart Failure
🗓️ Study Start (Actual) 30 June 2024
🗓️ Primary Completion (Estimated) 30 June 2028
✅ Study Completion (Estimated) 30 June 2028
👥 Enrollment (Estimated) 136
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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).

    Exclusion Criteria:

    • * 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
Ages Eligible for Study: 40 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 22 June 2023
  • First Submitted that Met QC Criteria 28 June 2023
  • First Posted 7 July 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 June 2023
  • Last Update Posted 7 July 2023
  • Last Verified June 2023
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