- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05366803
Women's Health Initiative Silent Atrial Fibrillation Recording Study (WHISH STAR)
May 4, 2022 updated by: Marco Perez, Stanford University
Women's Health Initiative Strong and Healthy Silent Atrial Fibrillation Recording Study
The purpose of the WHISH STAR study is to investigate whether or not those who are randomized to exercise intervention have higher rates of atrial fibrillation on review of medical records and, in a subset, on screening with a cardiac ECG patch monitor.
We will also study whether those with a known history of AF have any changes in AF hospitalizations due to exercise.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The Silent Atrial Fibrillation Recording study (STAR) study is an ancillary study of the NIH-funded Women's Health Initiative Strong and Healthy (WHISH).
The purpose of the Women's Health Initiative Strong and Healthy study (WHISH) is to investigate if light to moderate exercise decreases incident atrial fibrillation (AF) among women over 65 who have no baseline AF.
The purpose of the STAR study is to investigate the effect of exercise intervention on incident atrial fibrillation ascertained with diagnostic codes.
In a subset of women, subclinical atrial fibrillation will be ascertained with cardiac patch ECG monitoring technology (iRhythm's ZIO® XT Patch).
This subgroup of WHISH study participants will undergo an 8 day cardiac patch recording at baseline, six (6) months, and one (1) year.
Study Type
Interventional
Enrollment (Actual)
1257
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 100 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Subjects already enrolled in the parent WHISH study.
- Subjects who are at high risk of developing atrial fibrillation.
Exclusion Criteria:
- Subjects who have had atrial fibrillation at baseline.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physical Activity Intervention
The Physical Activity Intervention Group will receive guidance on being physically active, including aerobics, flexibility, balance, strength, and decreased sedentary time.
The primary resource is the National Institute of Aging Go4Life exercise and physical activity materials.
The materials are based on the United States national guidelines for physical activity for older adults.
Participants will wear the Zio patch monitor (electrocardiographic loop monitoring device) for 8 days at baseline, as well as at 6 months and again at one year, for a total of 3 times.
|
The PA intervention will consist of a multimodal activity program of aerobics, balance, strength, flexibility.
The intervention will involve encouraging participants to increase all forms of PA throughout the day and to decrease sedentary time, such as sitting.
This may include activities such as leisure sports, gardening, use of stairs instead of escalators, leisurely walks with friends, and less use of remote control devices.The intervention is conducted primarily by mail with website support and resources available.
|
No Intervention: Usual Activity Control
Participants will wear the Zio patch monitor (electrocardiographic loop monitoring device) for 8 days at baseline, as well as at 6 months and again at one year, for a total of 3 times.
Participants carry about their normal activities during this period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Incidence of Atrial Fibrillation Due to Exercise
Time Frame: One year
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One year
|
Number of Participants without Clinically Diagnosed Atrial Fibrillation (AF) Found to have Silent AF with Prolonged ECG Patch Monitoring
Time Frame: One year
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One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marco Perez, MD, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 8, 2017
Primary Completion (Actual)
February 11, 2020
Study Completion (Actual)
February 11, 2020
Study Registration Dates
First Submitted
May 4, 2022
First Submitted That Met QC Criteria
May 4, 2022
First Posted (Actual)
May 9, 2022
Study Record Updates
Last Update Posted (Actual)
May 9, 2022
Last Update Submitted That Met QC Criteria
May 4, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 40082
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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