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Mindful Steps: Promoting Physical Activity

Primary Purpose

Copd, Heart Failure

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mindful Steps

About this trial

This is an interventional treatment trial for Copd

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

BIDMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindful Steps

Usual Care

Arm Description

Web-based behavioral intervention

Outcomes

Primary Outcome Measures

Feasibility

intervention acceptability (qualitative interview)

Secondary Outcome Measures

Self-efficacy

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

Physical activity

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

Full Information

NCT ID

NCT03003780

First Posted

December 13, 2016

Last Updated

January 6, 2023

Sponsor

Beth Israel Deaconess Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03003780

Brief Title

Mindful Steps: Promoting Physical Activity

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

January 2, 2019 (Actual)

Primary Completion Date

July 6, 2021 (Actual)

Study Completion Date

July 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Copd, Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mindful Steps

Arm Type

Experimental

Arm Description

Web-based behavioral intervention

Arm Title

Usual Care

Arm Type

No Intervention

Intervention Type

Behavioral

Intervention Name(s)

Mindful Steps

Intervention Description

Integrated website, activity tracker, and mind-body training

Primary Outcome Measure Information:

Title

Feasibility

Description

intervention acceptability (qualitative interview)

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Self-efficacy

Description

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

Time Frame

baseline, months 3, 6, 9 and 12

Title

Physical activity

Description

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

Time Frame

baseline, months 3,6,9, and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

BIDMC

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33913819

Citation

Litrownik D, Gilliam EA, Wayne PM, Richardson CR, Kadri R, Rist PM, Moy ML, Yeh GY. Development of a Novel Intervention (Mindful Steps) to Promote Long-Term Walking Behavior in Chronic Cardiopulmonary Disease: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Apr 29;10(4):e27826. doi: 10.2196/27826.

Results Reference

derived

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Mindful Steps: Promoting Physical Activity

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