Recruiting

Mindful Steps

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT05934565

Conditions

Chronic Obstructive Pulmonary Disease

Chronic Heart Failure

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Mindful Steps

Study Details

Brief summary:

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 ID

NCT05934565

Start date

Apr 28, 2025

Status verified date

May, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Mindful Steps

Integrated website, activity tracker, and mind-body training

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Gloria Yeh

(617) 667-2845gyeh@bidmc.harvard.edu

Locations

VA Boston

Recruiting

Boston, Massachusetts, United States, 02132

BIDMC

Recruiting

Boston, Massachusetts, United States, 02215

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

May 28, 2025

Last verified

May, 2025

Keywords

  • Mind-Body Exercise
  • FitBit
  • Mindful Steps

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2025-05-28.