Mindful Steps: Promoting Physical Activity

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003780
• Other study ID #: 2016P000368
• Status: Completed
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: July 6, 2021

Study information

• Verified date: January 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a developmental project with two phases. The first phase will adapt an existing web-based intervention to incorporate mind-body exercises to develop a multi-modal intervention to promote physical activity in patients with COPD and HF. The second phase will pilot test this new intervention in a longitudinal study (subjects randomized to intervention or usual care).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 6, 2021
• Est. primary completion date: July 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of COPD OR clinical diagnosis of HF syndrome (New York Heart Association Class 1-3)
• Able to participate in an exercise program
• Have an active email account and access to a computer with internet connection

Exclusion Criteria:

• COPD or HF exacerbation in the previous month
• Inability to ambulate
• Clinical signs of unstable cardiovascular disease
• Hypoxemia during 6MWT
• Inability to collect at least 7 of 14 days of baseline step counts
• Current participation in a cardiac or pulmonary rehabilitation program.

Related Conditions & MeSH terms

• Copd
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
United States	BIDMC	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	intervention acceptability (qualitative interview)	6 months
Secondary	Self-efficacy	change in self-efficacy between time points (exercise self-efficacy scale)	baseline, months 3, 6, 9 and 12
Secondary	Physical activity	change in physical activity between time points (physical activity questionnaire)	baseline, months 3,6,9, and 12