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

NCT05934565 | Recruiting DMC

• 1 other identifier: R01AT012166-01A1
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 2

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

Keywords

Mind-Body Exercise; FitBit; Mindful Steps

Outcome Measures

Primary Outcomes (1)

• Change in physical activity

  Daily step counts will be measured as an objective proxy for physical activity using FitBit pedometers (FitBit Inspire 3)

  baseline, months 3, 6, 12, and 15

Secondary Outcomes (9)

• Change in self-efficacy

  baseline, months 3, 6, 12, and 15

• Change in intrinsic motivation

  baseline, months 3, 6, 12, and 15

• Qualitative inquiry

  months 6 and 12

• Change in disease-specific quality-of-life

  baseline, months 3, 6, 12, and 15

• Change in exercise engagement

  baseline, months 3, 6, 12, and 15

Study Arms (2)

Mindful Steps

EXPERIMENTAL

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

Behavioral: Mindful Steps

Usual Care

NO INTERVENTION

Pragmatic usual care (standard care through participant's healthcare provider including pharmacological treatment and general advice for physical activity); educational booklet

Interventions

Mindful Steps BEHAVIORAL

Integrated website, activity tracker, and mind-body training

Mindful Steps

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Brigham and Women's Hospital: collaborator
• VA Boston Healthcare System: collaborator
• University of Michigan: collaborator

Study Sites (2)

VA Boston

Boston, Massachusetts, 02132, United States

RECRUITING

BIDMC

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gloria Yeh

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Testing will be facilitated by study staff who are blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Mind-Body Research, BIDMC General Medicine Division; Associate Professor of Medicine, Harvard Medical School

Model Details: 2-arm parallel remotely delivered randomized controlled trial

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 7, 2023
• Study Start: April 28, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)