Women's Health Initiative Silent Atrial Fibrillation Recording Study

NCT ID: NCT05366803

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1257 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-08
• Study Completion Date: 2020-02-11

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Physical Activity

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical Activity

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Marco Perez

Associate Professor of Medicine (Cardiovascular Medicine)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marco Perez, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

References

Lin JY, Larson J, Schoenberg J, Sepulveda A, Tinker L, Wheeler M, Albert C, Manson JE, Wells G, Martin LW, Froelicher V, LaMonte M, Kooperberg C, Hlatky MA, Greenland P, Stefanick ML, Perez MV. Serial 7-Day Electrocardiogram Patch Screening for AF in High-Risk Older Women by the CHARGE-AF Score. JACC Clin Electrophysiol. 2022 Dec;8(12):1523-1534. doi: 10.1016/j.jacep.2022.08.024. Epub 2022 Oct 26.

Reference Type: DERIVED

PMID: 36543503 (View on PubMed)

Other Identifiers

40082

Identifier Type: -

Identifier Source: org_study_id