RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mindful Steps: Coupling Technology and Mind-Body Exercise to Facilitate Physical Activity in Chronic Cardiopulmonary Disease

Quick Facts

Study Start:2025-04-28
Study Completion:2028-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05934565

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Medical clearance from provider to participate in an exercise program
  3. * Have an active email account; access to a computer device (desktop, laptop, tablet, or smartphone that supports the Fitbit app).
  1. * COPD or HF exacerbation in the previous month
  2. * Inability to ambulate
  3. * Inability to collect at least 7 of 14 days of baseline step counts
  4. * Current participation in a cardiac or pulmonary rehabilitation program

Contacts and Locations

Study Contact

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

Study Locations (Sites)

VA Boston
Boston, Massachusetts, 02132
United States
BIDMC
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

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

Study Start Date2025-04-28
Study Completion Date2028-06-30

Study Record Updates

Study Start Date2025-04-28
Study Completion Date2028-06-30

Terms related to this study

Keywords Provided by Researchers

  • Mind-Body Exercise
  • FitBit
  • Mindful Steps

Additional Relevant MeSH Terms

  • Chronic Obstructive Pulmonary Disease
  • Chronic Heart Failure