Clinical trial NCT05934565: Mindful Steps 2.0: Promoting Physical Activity in Patients With COPD and HF
Official title: Mindful Steps: Coupling Technology and Mind-Body Exercise to Facilitate Physical Activity in Chronic Cardiopulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Chronic Heart Failure
Keywords: Mind-Body Exercise
FitBit
Mindful Steps
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: VA Boston Healthcare System
name: University of Michigan
First posted: 2023-07-07
Enrollment: 136
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-arm parallel remotely delivered randomized controlled trial
Primary purpose: TREATMENT

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.

Detailed description: This is a 2-arm parallel remotely delivered RCT. A total of 136 participants with COPD and/or HF will be randomized in a 1:1 ratio to one of 2 arms in a pragmatic design: 1) Mindful Steps multi-modal intervention, or 2) usual care (including an education booklet on walking). Subjects will participate in the intervention for 12 months. Testing will occur at baseline, 3, 6, 12 (end intervention), and 15 months (post-intervention follow up) for all participants. Physical activity as measured by pedometer (i.e., daily step counts) at 12 months is the primary outcome to assess the efficacy of the Mindful Steps intervention. Secondary outcomes include cognitive-behavioral measures that may relate to behavior change in a conceptual model (self-efficacy, intrinsic motivation, mindful awareness/interoception) as well as patient-centered clinical outcomes (HRQL, dyspnea, fatigue, PA engagement, sedentary behavior).

Eligibility criteria: 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

Primary outcomes:
measure: Change in physical activity
timeFrame: baseline, months 3, 6, 12, and 15
Secondary outcomes:
measure: Change in self-efficacy
timeFrame: baseline, months 3, 6, 12, and 15
measure: Change in intrinsic motivation
timeFrame: baseline, months 3, 6, 12, and 15
measure: Qualitative inquiry
timeFrame: months 6 and 12
measure: Change in disease-specific quality-of-life
timeFrame: baseline, months 3, 6, 12, and 15
measure: Change in exercise engagement
timeFrame: baseline, months 3, 6, 12, and 15
measure: Change in sedentary behaviors/time
timeFrame: baseline, months 3, 6, 12, and 15
measure: Change in dyspnea
timeFrame: baseline, months 3, 6, 12, and 15
measure: Change in fatigue
timeFrame: baseline, months 3, 6, 12 and 15
measure: Change in mindful awareness
timeFrame: baseline, months 3, 6, 12 and 15
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston
state: Massachusetts
city: Boston
country: United States
facility: BIDMC
state: Massachusetts
Study officials:
References: