Study Name:
Mindful Steps: A Web-Based Mind-Body Exercise Intervention to Promote Physical Activity in Chronic Cardiopulmonary Disease
Targeted Disease(s):
COPD
Purpose of Study:
This is a two arm randomized control trial. 136 participants with either COPD or heart failure will be randomly assigned to one of two arms at a 1:1 ratio. One arm is the Mindful Steps multimodal intervention which includes elements of mind-body exercise and an online platform to set goals and track physical activity. The second arm is standard of care treatment including an education booklet on walking. Subjects will participate in the study for 12 months with testing at baseline, 3 months, 6 months, 9 months, 12 months, and 15 months. Physical activity (daily step count), as measured by a pedometer at 12 months is the primary outcome and will be used to verify the efficacy of the Mindful Steps multimodal intervention. Secondary outcomes of interest include clinical outcomes (HQRL, dyspnea, fatigue, PA engagement, sedentary behavior) and behavioral changes (self-efficacy, intrinsic motivation, awareness, and introspection).
Study Dates:
June 30, 2024 - June 30, 2028
Study Location:
Nationwide
Funding Source:
NIH
Contact:
Brianna Wang
617-754-1410
mindfulsteps@bidmc.harvard.edu
ClinicalTrails.gov Identifier:
NCT05934565
