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Women's Health Initiative Silent Atrial Fibrillation Recording Study (WHISH STAR)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation

Eligibility Criteria

65 Years - 100 Years (Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physical Activity Intervention

Usual Activity Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Incidence of Atrial Fibrillation Due to Exercise
Number of Participants without Clinically Diagnosed Atrial Fibrillation (AF) Found to have Silent AF with Prolonged ECG Patch Monitoring

Secondary Outcome Measures

Full Information

First Posted
May 4, 2022
Last Updated
May 4, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05366803
Brief Title
Women's Health Initiative Silent Atrial Fibrillation Recording Study
Acronym
WHISH STAR
Official Title
Women's Health Initiative Strong and Healthy Silent Atrial Fibrillation Recording Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 8, 2017 (Actual)
Primary Completion Date
February 11, 2020 (Actual)
Study Completion Date
February 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1257 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Activity Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Activity Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Incidence of Atrial Fibrillation Due to Exercise
Time Frame
One year
Title
Number of Participants without Clinically Diagnosed Atrial Fibrillation (AF) Found to have Silent AF with Prolonged ECG Patch Monitoring
Time Frame
One year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The participants are all older women, since the parent study is a post-menopausal study from the Women's Health Initiative.
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Perez, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Women's Health Initiative Silent Atrial Fibrillation Recording Study

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