Physical Activity Clinical Trial
Official title:
Physical Activity Telehealth Intervention After Percutaneous Coronary Procedures
Verified date | August 2023 |
Source | University of Nebraska |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to test the feasibility of using targeted daily cell phone interaction to facilitate behavior change for physical activity in previously-sedentary individuals who have recently undergone a percutaneous coronary intervention (PCI).
Status | Completed |
Enrollment | 50 |
Est. completion date | September 1, 2014 |
Est. primary completion date | September 1, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - First-time PCI cardiac revascularization - Age of 19 years or older - Residing in a rural community - Previously sedentary - Physician approval to participate in this study - Oriented to person, place, and time - Able to see and hear (able to read the screen of a cell phone, and hear audio over a cell phone) - Able to speak and read English. Exclusion Criteria: - Residing in area of Nebraska that does not have cell phone transmission - Physical impairments limiting participation in physical activity and exercise following PCI - Evaluated by their physician to be TOO HIGH RISK for moderate physical activity as proposed in this study |
Country | Name | City | State |
---|---|---|---|
United States | Bryan LGH Medical Center | Lincoln | Nebraska |
United States | Nebraska Heart Hospital | Lincoln | Nebraska |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska | National Institute of Nursing Research (NINR) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility Aspects of the Physical Activity Telehealth Intervention | Evaluate the feasibility of each component of this pilot study, in order to refine the intervention for a larger clinical trial. This will include: Evaluate all aspects of implementation (numbers of subjects contacted, enrollment, attrition; problems and solutions identified using the telehealth platform, time for delivery; subject acceptance and perception). Evaluate feasibility of the data collection methods (time required for data collection, missing data, reliability estimates of outcomes). Estimate effect sizes for sample size determinations for a future, larger clinical trial. |
6 months | |
Secondary | Physical Activity Measures | Pilot test the impact of the Physical Activity Promotion Telehealth Intervention in post-PCI patients over time compared to patients receiving attention only, on the following outcomes: Movement through the stages of readiness for physical activity. Behavior change constructs (self efficacy for exercise, decisional balance, and use of processes for change). Amount of physical activity (estimated energy expenditure per day as measured by the actigraph accelerometer) and exercise (reported minutes exercising per day). |
6 months |
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