Mindful Steps 2.0: Promoting Physical Activity in Patients With COPD and HF

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT05934565
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mindful Steps — BEHAVIORAL
    Integrated website, activity tracker, and mind-body training

Study Details

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.

Key Dates

Start date
Apr 28, 2025
Status verified
May 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
136 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mindful Steps
    Multi-modal web intervention including: pedometer with individualized step-count goals, motivational and educational content, online community forum, mind-body videos (short themed clips that support walking, plus library of mind-body exercises), online group mind-body exercise classes, star incentive system; educational booklet
  • No Intervention: Usual Care
    Pragmatic usual care (standard care through participant's healthcare provider including pharmacological treatment and general advice for physical activity); educational booklet

Primary Outcome Measure

Change in physical activity [ Time Frame: baseline, months 3, 6, 12, and 15 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
BIDMCBostonMassachusetts02215-
VA BostonBostonMassachusetts02132-

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