Mindful Steps: Promoting Physical Activity

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03003780
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 29.9
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Copd; Heart Failure	Behavioral: Mindful Steps	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Mindful Steps: Coupling Technology and Mind-Body Exercise to Facilitate Physical Activity in Patients With Cardiopulmonary Disease
• Actual Study Start Date: Jan 2, 2019
• Anticipated Primary Completion Date: Jul 1, 2021
• Anticipated Study Completion Date: Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindful Steps Web-based behavioral intervention	Behavioral: Mindful Steps; Integrated website, activity tracker, and mind-body training
No Intervention: Usual Care

Outcome Measures

Primary Outcome Measures

1. Feasibility [6 months]

   intervention acceptability (qualitative interview)

Secondary Outcome Measures

1. Self-efficacy [baseline, months 3, 6, 9 and 12]

   change in self-efficacy between time points (exercise self-efficacy scale)

2. Physical activity [baseline, months 3,6,9, and 12]

   change in physical activity between time points (physical activity questionnaire)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BIDMC	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Beth Israel Deaconess Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gloria Y. Yeh, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT03003780
• Other Study ID Numbers: 2016P000368
• First Posted: Dec 28, 2016
• Last Update Posted: Feb 26, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Feb 26, 2020