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

Overview

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).

Interventions

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

Primary outcome measures

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

Secondary outcome measures (9)

• Change in self-efficacy [Time frame: baseline, months 3, 6, 12, and 15]
• Change in intrinsic motivation [Time frame: baseline, months 3, 6, 12, and 15]
• Qualitative inquiry [Time frame: months 6 and 12]
• Change in disease-specific quality-of-life [Time frame: baseline, months 3, 6, 12, and 15]
• Change in exercise engagement [Time frame: baseline, months 3, 6, 12, and 15]
• Change in sedentary behaviors/time [Time frame: baseline, months 3, 6, 12, and 15]
• Change in dyspnea [Time frame: baseline, months 3, 6, 12, and 15]
• Change in fatigue [Time frame: baseline, months 3, 6, 12 and 15]
• Change in mindful awareness [Time frame: baseline, months 3, 6, 12 and 15]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 2 centers

• VA Boston — Boston
• BIDMC — Boston

Identifiers

NCT: NCT05934565 · R01AT012166-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗