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

Stanford University

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Behavioral: Physical Activity

Study type: Interventional

Funder types: Other

Identifiers

NCT05366803

40082

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,257 patients

Sex: Female

Ages: 65 to 100 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,257 participants in 2 patient groups

Physical Activity Intervention

Experimental group

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.

Treatment:

Behavioral: Physical Activity

Usual Activity Control

No Intervention group

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.